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Available Tests

Specimen Sources, Test List by Alphebetical Order ->

Gynecology / Urology

  • 150 Actinomyces europaeus by Real-Time PCR
    • Clinical significance: Although Actinomyces species can be found as normal flora of the mouth they are also considered opportunistic pathogens in infections associated with human bite wounds, abscesses, infections of the eye and mouth, as well as the gastrointestinal, genital, and urinary tracts. A. europaeus has been associated with cystitis and is often recovered from abscesses of various body sites. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 143 Actinomyces israelii by Real-Time PCR
    • Clinical significance: Actinomyces israelii is a filamentous anaerobic gram-positive bacteria. The infection begins as an inflammatory soft tissue mass, which can enlarge into an abscess-like swelling. All species of Actinomyces are normal commensal inhabitants of the oral and buccal cavities in humans. The anaerobic actinomycetes are not transmitted sexually and are not generally considered as part of the normal vaginal flora. Colonization in the female genital tract is stimulated greatly by the presence of a foreign body, such as intrauterine contraceptive devices (IUCDs), hairpins, and even surgical sutures. Colonization may be asymptomatic or minimally symptomatic, presenting only as shedding of actinomycotic granules into the vaginal fluid. The clinical presentation includes foul-smelling vaginal discharge, intermittent pelvic pain, abnormal bleeding and one or more pelvic masses. In the acute phase, pelvic abscesses are often unilateral, involving a single fallopian tube and ovary. Single or multiple abscesses may form in the uterine wall, usually surrounding an embedded IUCD. The most extensive disease may present with a frozen or “woody” pelvis demonstrating extensive adhesions and scarring as part of the inflammatory response. A subset of genital actinomyces cases will present with some abnormalities of vaginal fluids on PAP smear. Anaerobic actinomycetes are successfully cultured in only about 10% of those cases investigated, which makes molecular amplification techniques a more feasible option for the clinical diagnosis of vaginal actinomyces. The anaerobic actinomycetes are considered universally susceptible to penicillin, which is the drug of choice if antibiotic therapy is needed.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 149 Actinomyces turicensis by Real-Time PCR
    • Clinical significance: Actinomyces turicensis is a gram positive facultative anaerobe that is a commensal part of the oropharynx, gastrointestinal tract, and female genital tract. Although Actinomyces species are not considered to be pathogenic by nature, but rather part of the normal flora, they are capable of colonizing and establishing pathogenic infections within neighboring tissues upon a breach in the integrity of the mucosal membranes that typically sequester them resulting in the chronic condition Actinomycosis. A. turicensis is one of the more commonly isolated species of the genus Actinomyces known to induce the Actinomycosis, a condition which is characterized by abscess formation, tissue fibrosis, and draining sinuses. While, clinically, infections of the oral and cervicofacial region are the most common, Actinomycosis also frequently occurs within the thoracic, abdominopelvic, and central nervous system compartments.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 222 Adenovirus by Real-Time PCR
    • Clinical significance: Adenoviruses cause a number of self-limiting, but often highly infectious, diseases that affect multiple organs, most commonly those associated with the respiratory and genitourinary tracts. Adenovirus is a relatively harmless pathogen in healthy individuals, but can cause a variety of symptoms in young children and the immunocompromised. Transmission can occur from direct, person-to-person contact or through contact with a contaminated surface or object. Adenovirus infections are usually asymptomatic and may cause a variety of symptoms, including: respiratory problems, gastroenteritis, pink eye, pharyngoconjunctival fever, skin rashes, and genitourinary tract infections including cervicitis, urethritis and hemorrhagic cystitis. The most severe cases of adenovirus infection may result in pneumonia, croup, and bronchitis. In this assay DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 142 Atopobium vaginae by Real-Time PCR
    • Clinical significance: Atopobium vaginae, a facultative, anaerobic bacteria, is the first of a group of previously unremarked microorganisms that has recently become associated with Bacterial Vaginosis (BV) following the advent of PCR-based diagnostics. Mounting evidence has demonstrated a direct link between the presence of A. vaginae and BV, a condition which left untreated, may lead to adverse conditions such as pelvic inflammatory disease, preterm birth, and postpartum endometritis. Abnormal vaginal micro flora has also been associated with increased susceptibility to HIV, Chlamydia trachomatis, and Neisseria gonorrhoeae infections. The detection of A. vaginae by PCR has been shown to be as sensitive for BV as the detection of Gardnerella vaginalis (96% and 99% respectively). However, A. vaginalis was demonstrated to be more specific for BV than is G. vaginalis (77% and 35% respectively). In this assay DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 133 Bacterial Vaginosis Panel by Real-Time PCR

    • 132 Gardnerella vaginalis by Real-Time PCR
      124 Mobiluncus mulieris and M. curtisii by Real-Time PCR
      125 Bacteroides fragilis by Real-Time PCR

    • Clinical significance: Bacterial Vaginosis (BV) is a polymicrobial syndrome characterized by a change in the vaginal micro flora from a healthy ecosystem dominated by Lactobacillus species to a pathogenic ecosystem dominated by Gram-negative and –positive anaerobic bacteria. BV diagnosis is complicated by the polymicrobial nature of the condition and the fact that this syndrome is often asymptomatic. Serious consequences of BV include increased STD/HIV acquisition, preterm labor, and infections following obstetric and gynecologic surgery. While the mechanism of BV is not understood, the presence of specific bacterial species, including Gardnerella vaginalis, Prevotella, and Mobiluncus species are currently used as diagnostic indicators. Other microorganisms, such as Ureaplasma urealyticum, Mycoplasma, Bacteroides species, and A. vaginae have been shown to be associated with BV in medical research publications but their presence in the vagina is not yet considered to be a diagnostic indicator of BV by the CDC. In this assay DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 125 Bacteroides fragilis by Real-Time PCR
    • Clinical significance: Bacteroides fragilis is an anaerobic bacteria that is commonly associated with Bacterial Vaginosis (BV). BV is a leading cause of abnormal vaginal discharge and odor. BV constitutes a massive microecologic alteration of the vaginal flora that is characterized by: (1) decreased or absent Lactobacillus spp., (2) a logarithmically increased concentration of Gardnerella vaginalis (> 10^8 to 10^11 CFU/g) and (3) logarithmically increased concentrations of a set of potentially pathogenic bacteria, including Bacteroides spp. In this assay, DNA is extracted from the specimen and subjected to Real-Time PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 147 Bacteroides ureolyticus by Real-Time PCR
    • Clinical significance: Bacteroides ureolyticus is an obligate anaerobic gram-negative rod-shaped bacterium that was first described in clinical specimens in 1948. It is the most commonly detected Bacteroides strain after B. fragilis. Identification of this organism from infections within the buccal cavity, intestinal tract, urogenital tract, and blood has been reported. It has also been isolated from mixed cultures of infections involving nearly every organ system in humans. B. ureolyticus is associated with ulcerative lesions of both the external and internal genitalia, including the perineal area, as well as abscesses and has been implicated in non-gonoccocal urethritis (NGU); one study reported its identification in 50% of the evaluated men with confirmed NGU. It is thought to cause damage to the urethral mucosa via its expression of an endotoxin. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 551 Candida albicans by Real-Time PCR
    • Clinical significance: Between 70% to 90% of yeast strains isolated from the vagina belong to the species Candida albicans. C. albicans is one of the major causes of Candida Vaginitis (CV). In the United States, CV is currently the second most common cause of vaginal infection, with bacterial vaginosis the most common diagnostic entity. CV affects most females at least once during their lives at an estimated rate of 70% to 75%, of whom 40% to 50% will experience a recurrence. Studies indicate that CV is a frequent diagnosis among young women, affecting as many as 15% to 30% of symptomatic women visiting a clinician; by the age of 25, half of all college women will have experienced at least one episode of CV. C. albicans and C. glabrata represent the most common fungal causes of both complicated and uncomplicated urinary tract infections. In this assay, DNA is extracted from the specimen and subjected to Real-Time PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 581 Candida albicans fluconazole resistance by X-Plate Technology™

    • Only performed after a #551 is positive. Charges will be the total of tests #551 + #581.

    • Clinical significance: In the United States, fungal infections have increased significantly over the past three decades. Candida albicans remains the primary species involved in Candida infections, 40% to 70%. Candida Vaginitis (CV) affects most females at least once during their lives, at an estimated rate of 70% to 75%. Identifying the species and the antimicrobial susceptibility of an isolate involved in infection is imperative for the proper course of treatment. If an isolate is resistant or susceptible-dose dependent, treatment with azole antifungals is ineffective and can increase resistance rapidly. C. albicans isolates are resistant in approximately 1% to 10% of cases.
      • Method:
      • X-Plate Technology™
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • Up to 72 hours due to reflex testing
  • 576 Candida dubliniensis by Real-Time PCR
    • Clinical significance: First described in 1995, Candida dubliniensis is reported to have been previously misidentified as Candida albicans. It is associated with oral candidiasis and has been recovered from the vaginal tract of women. Although it is closely related to C. albicans, its differences in virulence and its ability to rapidly develop resistance to traditional antifungal agents makes it clinically relevant. C. dubliniensis is an opportunistic infection that is of particular concern in immunocompromised patients. The use of molecular techniques, such as PCR, enables the clinician to differentiate C. dubliniensis from other species of Candida to facilitate diagnosis and proper treatment. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 559 Candida glabrata by Real-Time PCR
    • Clinical significance: C. glabrata has emerged as the second most common cause of invasive fungal infection and is the leading non-albicans species involved in Candida Vaginitis (CV), accounting for up to 20% of infections in immune-competent women. It is thought that the widespread use of topical antifungals, especially in short courses, may contribute to selection for non-albicans yeasts, which are less susceptible to these agents. C. glabrata has also been shown to intrinsically exhibit low level resistance but has the ability to rapidly acquire high level resistance to antifungals. C. glabrata is associated with CV and affects most females at least once during their lives at an estimated rate of 70% to 75%, of whom 40% to 50% will experience a recurrence. In the United States CV is currently the second most common cause of vaginal infections, with bacterial vaginosis the most common. Most studies indicate that CV is a frequent diagnosis among young women, affecting as many as 15% to 30% of symptomatic women visiting a clinician; by the age 25 years, half of all college women will have experienced at least one episode of CV. C. albicans and C. glabrata represent the most common fungal causes of both complicated and uncomplicated urinary tract infections. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 579 Candida glabrata azole resistance (CDR1) by Quantitative PCR
    • This test has been replaced by Test 581: Candida glabrata fluconazole resistance by X-Plate Technology™
  • 582 Candida glabrata fluconazole resistance by X-Plate Technology™

    • Only performed after a #559 is positive. Charges will be the total of tests #559 + #582.

    • Clinical significance: In the United States, fungal infections have increased significantly over the past three decades, especially amongst non-albicans species. Although Candida albicans remains the primary species involved in Candida infections (40% to 70%), Candida glabrata is now recognized as the second most common cause of infection, 10% to 30%. Candida Vaginitis (CV) affects most females at least once during their lives, at an estimated rate of 70% to 75%. The widespread use of azole antifungals may be a contributing factor in the emergence of non-albicans species. Identifying the species and the antimicrobial susceptibility of an isolate involved in infection is imperative for the proper course of treatment. Surveillance programs performed over the past few decades have demonstrated that azole resistance is becoming very common among C. glabrata and other non-albicans species. If an isolate is resistant or susceptible-dose dependent, treatment with azole antifungals is ineffective and can increase resistance rapidly.
      • Method:
      • X-Plate Technology™
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • Up to 72 hours due to reflex testing
  • 578 Candida kefyr by Real-Time PCR
    • Clinical significance: Candida kefyr is one of the six strains of Candida, of approximately 154 species, that is commonly associated with infections in humans. This species, previously reported in the literature by the obsolete name of Candida pseudotropicalis, has been reported as an emerging pathogen. Candidiasis has a wide clinical spectrum, capable of affecting almost any organ or system in the body. Infections range from localized, superficial infections to dissemination in the blood stream. Considered to be a relatively rare infection, found in approximately 1% of fungal isolates reported, C. kefyr infections have been documented from burn wounds, blood and vaginal infections. More recently, the frequency of C. kefyr infections has increased within oncohematologic patients, particularly those with neutropenic, myeloid and lymphoblastoid leukemias. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 566 Candida krusei by Real-Time PCR
    • Clinical significance: Candida krusei, which has traditionally been implicated in urinary tract infections, has recently been associated with certain instances of fungal vaginitis, particularly recurrent fungal vaginitis. Candida Vaginitis (CV) resulting from C. krusei infection is often chronic due to the organism’s inherent resistance to conventional anti-fungal therapies, necessitating the need for prolonged treatment courses. The incidence of C. krusei fungemia within leukemic populations has been on the rise within recent years, doubling within a five year span, and is highly lethal within the neutropenic subpopulation receiving fluconazole prophylaxis. As a result, treatment needs to be initiated quickly and aggressively. The use of molecular techniques, such as Real-Time PCR, enables the clinician to differentiate C. krusei from other species of Candida to facilitate diagnosis and proper treatment. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 577 Candida lusitaniae by Real-Time PCR
    • Clinical significance: Candida lusitaniae is considered a nosocomial bloodstream pathogen that is becoming increasingly associated with Candidemia. It is an opportunistic infection and therefore is associated with immunocompromised individuals. C. lusitaniae is known to enter the host through the urogenital and respiratory tracts or through intravascular catheters. It is also quite resistant to amphotericin B, a common antifungal treatment. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 558 Candida parapsilosis by Real-Time PCR
    • Clinical significance: C. parapsilosis accounts for 1% of vaginal yeast isolates. It is thought that the widespread use of topical azole antifungals, especially in short courses, may contribute to selection for non-albicans yeasts, which are less susceptible to these agents than C. albicans. C. parapsilosis is associated with Candida Vaginitis (CV). CV affects most females at least once during their lives at an estimated rate of 70% to 75%, of whom 40% to 50% will experience a recurrence. In the United States CV is currently the second most common cause of vaginal infections, with bacterial vaginosis the most common diagnostic entity. Studies indicate that CV is a frequent diagnosis among young women, affecting as many as 15% to 30% of symptomatic women visiting a clinician; by the age of 25, half of all college women will have experienced at least one episode of CV. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 583 Candida parapsilosis fluconazole resistance by X-Plate Technology™

    • Only performed after a #558 is positive. Charges will be the total of tests #558 + #583.

    • Clinical significance: In the United States, fungal infections have increased significantly over the past three decades, especially amongst non-albicans species. Candida Vaginitis (CV) affects most females at least once during their lives, at an estimated rate of 70% to 75%. The widespread use of azole antifungals may be a contributing factor in the emergence of non-albicans species. Identifying the species and the antimicrobial susceptibility of an isolate involved in infection is imperative for the proper course of treatment. Surveillance programs performed over the past few decades have demonstrated that azole resistance is becoming very common among non-albicans species. If an isolate is resistant or susceptible-dose dependent, treatment with azole antifungals is ineffective and can increase resistance rapidly. Candida parapsilosis typically are not resistant to azoles, however approximately 1% of isolates are resistant.
      • Method:
      • X-Plate Technology™
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • Up to 72 hours due to reflex testing
  • 557 Candida tropicalis by Real-Time PCR
    • Clinical significance: Candida tropicalis accounts for 1% to 5% of vaginal yeast isolates and may be associated with a higher rate of recurrence after standard treatment. Although C. tropicalis is still very susceptible to azole antifungals, an increase in resistance has been observed in the US. It is thought that the widespread use of topical azole antifungals, especially in short courses, may contribute to selection for non-albicans yeasts, which are less susceptible to these agents than C. albicans. C. tropicalis is associated with Candida Vaginitis (CV). CV affects most females at least once during their lives, at an estimated rate of 70% to 75%, of whom 40% to 50% will experience a recurrence. In the United States CV is currently the second most common cause of vaginal infections, with bacterial vaginosis the most common diagnostic entity. Studies indicate that CV is a frequent diagnosis among young women, affecting as many as 15% to 30% of symptomatic women visiting a clinician; by the age of 25, half of all college women will have experienced at least one episode of CV. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 584 Candida tropicalis fluconazole resistance by X-Plate Technology™

    • Only performed after a #557 is positive. Charges will be the total of tests #557 + #584.

    • Clinical significance: In the United States, fungal infections have increased significantly over the past three decades, especially amongst non-albicans species. Candida Vaginitis (CV) affects most females at least once during their lives, at an estimated rate of 70% to 75%. The widespread use of azole antifungals may be a contributing factor in the emergence of non-albicans species. Identifying the species and the antimicrobial susceptibility of an isolate involved in infection is imperative for the proper course of treatment. Surveillance programs performed over the past few decades have demonstrated that azole resistance is becoming very common among non-albicans species. If an isolate is resistant or susceptible-dose dependent, treatment with azole antifungals is ineffective and can increase resistance rapidly.
      • Method:
      • X-Plate Technology™
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • Up to 72 hours due to reflex testing
  • 574 Candida utilis by Real-Time PCR
    • Clinical significance: Candida utilis has traditionally been described as an industrially significant yeast. However, it was recently implicated in a case of recurrent urinary tract infection and candidemia and has also been associated with fungal keratitis. The use of molecular techniques, such as Real-Time PCR, enables the clinician to differentiate C. utilis from other species of Candida to facilitate diagnosis and proper treatment. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 560 Candida Vaginitis Panel by Real-Time PCR

    • 551 Candida albicans by Real-Time PCR
      557 Candida tropicalis by Real-Time PCR
      558 Candida parapsilosis by Real-Time PCR
      559 Candida glabrata by Real-Time PCR

    • Clinical significance: The incidence of vulvovaginal candidiasis (VVC) is poorly documented, particularly since VVC is not a reportable entity. Regrettably, without laboratory confirmation, VVC is misdiagnosed in as many as 50% of cases. Seventy to ninety percent of yeast strains isolated from the vagina belong to the species of Candida albicans. Other vaginal yeast strains isolated include C. glabrata, C. parapsilosis, and C. tropicalis, accounting for the remaining VVC cases in the United States. Vulvovaginal candidiasis accounts for about one-third of all the vaginitis cases seen in private practices. Patients with VVC generally complain of perivaginal pruritus, often with little or no discharge. Currently, VVC diagnosis is based on the addition of 10% potassium hydroxide to vaginal discharge on a slide (the “whiff” test). However, the whiff test fails to elicit a confirmatory odor in most women with VVC. Direct microscopic examination of wet mount vaginal discharge fails to reveal the fungi in 30% to 50% of infected women. A commercially available latex agglutination test has a limited sensitivity of 60%. MDL has developed a highly sensitive and specific PCR based assay that can differentiate among the four VCC-causing pathogens. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 105 Chlamydia trachomatis by Real-Time PCR
    • Clinical significance: Chlamydia trachomatis is the causative agent of the disease Chlamydia and is the most common sexually transmitted bacterial agent. In women this bacterium causes cervicitis, urethritis, endometritis and salpingitis. In more complicated cases, C. trachomatis infections may result in tubal scarring, infertility, and ectopic pregnancy. In men it causes urethritis and proctatitis. If left untreated, Chlamydia may develop into lymphogranuloma venereum. Other forms of infection also seen are trachoma, the most preventable form of blindness, and conjunctivitis in neonates. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 554 Cryptococcus neoformans by Real-Time PCR
    • Clinical significance: Cryptococcus neoformans is found in aged pigeon droppings, such as those accumulated on window ledges and rooftops. Infection is commonly seen in AIDS and transplant patients on immunosuppressive therapies and primarily manifests as a respiratory infection causing severe pneumonia. It also causes central nervous system disturbances and skin lesions that may be non-specific but are often the first sign of infection. India ink smears can be useful as supportive evidence of infection but are not definitive. A combination of culture and smears with antibody or antigen detection assays are traditionally used. Molecular methods, such as PCR, offer a rapid route of diagnosis with increased sensitivity and specificity. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 1201 Cystic Fibrosis Gene Carrier Screening by Bio-Plex Analysis
    • Clinical significance: Cystic Fibrosis (CF) is an autosomal recessive inheritable disease that afflicts approximately 30, 000 people within the United States and 70, 000 worldwide, with 1, 000 new cases diagnosed each year. Due to its recessive inheritable pattern, people may be carriers of the disease, having inherited a defective gene but not exhibiting symptoms. It is estimated that an additional ten million, or one in every thirty-one Americans, are carriers. Carrier status occurs more frequently within Ashkenazi Jewish and Caucasians of European descent populations, each of which has a one in twenty-nine carrier risk rate. The defective gene responsible for CF was identified in 1989 as the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene. The CFTR protein serves as a chloride channel within epithelial cells; disruption of its function induces an electrolyte imbalance that results in excess sodium chloride levels in sweat, a hallmark and diagnostic indicator of disease, and is believed to cause the thickening of fluids in the lungs and digestive tract. Since its discovery, more than 1, 500 mutations have been defined within the CFTR gene. Both the American College of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics (ACMG) have developed guidelines for genetic testing to include twenty-three of the most common CFTR mutations. The ?F508 mutation accounts for approximately two-thirds of all mutant CF alleles worldwide and 70% of the CF cases within the United States, while the W1282X mutation predominates within the Ashkenazi Jewish population. The MDL Cystic Fibrosis Gene Carrier Screening by Bio-Plex Analysis evaluates thirty-two possible point mutations. Reflexive testing for six additional mutations is automatically initiated following positive identification of either the ?F508 or R117H mutations. In this assay DNA is extracted and subjected to single nucleotide polymorphism analyses by Bio-Plex.
      • Method:
      • Bio-Plex Analysis
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 207 Cytomegalovirus (CMV) by Real-Time PCR
    • Clinical significance: Cytomegalovirus (CMV) infects 50% to 80% of Americans by the age of 40 and is known to cause mild or asymptomatic infection in most healthy individuals. The virus is spread from person-to-person through most bodily fluids. Congenital infection, which occurs when an infected mother passes the infection along to the fetus, may result in hearing, vision, neurologic and developmental problems shortly after birth. CMV viral shedding can be detected in the vaginal secretions of infected women. The use of molecular techniques, such as Real-Time PCR, enables the clinician to detect this viral shedding thus enabling diagnosis and treatment prior to delivery. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 205 Epstein-Barr virus (EBV) by Real-Time PCR
    • Clinical significance: EBV is the causative agent of infectious mononucleosis, which occurs primarily in late adolescence and early adulthood. It is characterized by malaise, fever, hepatosplenomegally, lymphadenopathy, and abdominal discomfort. EBV has also been associated with post-transplant lymphoma, Burkitt’s lymphoma, and nasopharyngeal carcinoma. Reactivations of this disease are suspected in chronic fatigue syndrome. EBV is one of the most common human viruses and it is estimated that worldwide as many as 80% to 90% of all adults have at one time been infected. Although it is normally a self-limiting infection, complications can occur, such as splenomegaly, hepatitis, pericarditis, or central nervous system involvement. In certain rare instances, EBV infections may be fatal. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 141 Escherichia coli by Real-Time PCR
    • Clinical significance: Escherichia coli (E. coli) are facultative anaerobic Gram-negative rods that normally live as commensal (i.e. non-pathogenic) organisms on the skin and within the gastrointestinal tract of humans and animals. Certain strains, referred to as uropathogenic E. coli (UPEC), exit the GI tract, colonize the perineum and, when they come in contact with the urethra, ascend into the bladder to cause a urinary tract infection (UTI). UPEC is also the cause of more than 90% of urinary tract infections (UTI), which primarily occur in young, sexually active women. However, UPEC is also the cause of 78% of male UTI, and is a significant cause of prostatitis. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 132 Gardnerella vaginalis by Real-Time PCR
    • Clinical significance: Gardnerella vaginalis is a Gram-variable anaerobic bacteria that can be present at low numbers as a normal constituent of the vaginal flora of some women. G. vaginalis is often present at high levels in women with Bacterial Vaginosis (BV) and the presence of this microorganism can be used to diagnose BV, usually in conjunction with a decrease in the numbers of Lactobacillus, and the presence of Mobiluncus species. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 115 Genital Ulcer Disease Panel (HSV-1 & HSV-2) (H. ducreyi, T. pallidum) by Real-Time PCR

    • 110 Treponema pallidum by Real-Time PCR
      122 Haemophilus ducreyi by Real-Time PCR
      126 Herpes subtype (HSV-1 & HSV-2) by Real-Time PCR

      When sampling a crusted over lesion, moisten the swab with sterile saline solution prior to swabbing.

    • Clinical significance: The three major causes of Genital Ulcer Disease (GUD) in the United States are Herpes simplex virus, Treponema pallidum (syphilis), and Haemophilus ducreyi (chancroid). Currently, the diagnosis of GUD is based primarily on the clinical presentation of the ulcer itself. However, agent-specific diagnosis based solely on clinical evaluations are often obscured by multiple and mixed infections. As treatment options vary, it is medically necessary to identify the causative agent of GUD. In this assay, DNA is extracted from the specimen and subjected to PCR amplification for these three pathogens. The Herpes subtype assay, if positive, will determine whether the virus detected was HSV-1, HSV-2, or both HSV-1 and HSV-2.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 1112 Group A Streptococcus by Real-Time PCR
    • Clinical significance: Streptococcus pyogenes (Group A Streptococcus) is a gram positive extracellular bacteria that colonizes the throat and skin. It is the cause of many human diseases which range from mild skin infections to invasive life threatening disease. Group A Streptococcus is the most common cause of bacterial pharyngitis (Strep throat) and is also associated with scarlet fever, impetigo, Streptococcal toxic shock syndrome and necrotizing fasciitis. Autoimmune mediated post infection sequelae such as rheumatic fever, rheumatic heart disease, glomerulonephritis and reactive arthritis can potentially result in disability or death. Group A Streptococcus has been shown to infect the vaginal mucosa and uterus leading to sever disease or septicemia. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 122 Haemophilus ducreyi by Real-Time PCR

    • When sampling a crusted over lesion, moisten the swab with sterile saline solution prior to swabbing.

    • Clinical significance: H. ducreyi is the causative agent of the sexually transmitted disease soft chancre or chancroid. It is most commonly diagnosed in males, probably due to the asymptomatic or inapparent infection that often occurs in females. It typically takes 5 to 7 days after exposure for symptoms to present, but may take as long as several weeks. A tender, small, solid, raised skin lesion will develop with a red base that may develop into a raised sore containing pus. It may then become an open ulcer within 2 days. These lesions are generally limited to the genitalia or perianal area. The lesion erodes to form a painful ulcer and swelling of lymph nodes in the groin area (bubo) in approximately 50% of patients. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 113 Herpes simplex virus (HSV) viral load by Real-Time PCR

    • Only performed after a #126 is positive. Charges will be the total of tests #126 + #113.

    • Clinical significance: HSV infections are epidemic in the United States. Genital herpes is the most common cause of genital ulcer disease in the developed world. HSV quantitative DNA based assay is performed by quantitative Real-Time PCR. Real-Time PCR is an ultra sensitive assay that utilizes intermolecular controls that coincide with the tested specimen. Evaluation of viral load is essential for patient stratification, predicting clinical outcome, and evaluating disease progression. This assay is performed only after a positive result is obtained from test #126, Herpes subtype (HSV-1 & HSV-2) by Real-Time PCR.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • Up to 72 hours due to reflex testing
  • 126 Herpes subtype (HSV-1 & HSV-2) by Real-Time PCR
    • Clinical significance: HSV infections are epidemic in the United States. Genital herpes is the most common cause of genital ulcer disease in the developed world. HSV-2 is the most common cause of genital ulcers in the United States and is the cause of more than 90% of recurrent disease. Most painful and annoying recurrent genital herpes is due to HSV-2 and almost all recurrent cold sores or fever blisters are due to HSV-1. HSV-1 classically presents as herpes gingivostomatitis, an infection of the oral mucosa. It can also cause conjunctivitis, keratitis, and herpetic whitlow. However, genital herpes also can be caused by HSV-1. It has been documented that as many as one third of herpes infections are due to HSV-1, particularly in adolescents and young adults. This type of genital herpes is much less frequently recurrent and each recurrence usually lasts only a few days. The main application for HSV subtyping is with regard to the clinical issue of recurrent infection. Although antigen detection systems for HSV can be specific and sensitive when applied to the evaluation of clinical genital lesions, the titer of HSV present during asymptomatic reactivations is 10- to 100-fold less than the titer present during symptomatic episodes. Therefore, methods based on the detection of viral proteins in such cases are less sensitive than DNA amplification assays. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 140 HPV Type-Detect® by Real-Time PCR
    • This test has been replaced by Test 152: HPV Type-Detect® 2.0 by Bio-Plex Analysis. (Nov. 11, 2008)
  • 152 HPV Type-Detect® 2.0 by Bio-Plex Analysis
    • Papillomaviruses are a diverse group of viruses that have been found in more than 20 different mammalian species. To date, there are more than 200 known HPV types. HPV infection is very common, though most infected individuals eliminate evidence of the virus without developing clinical manifestations. Thus, very few HPV-infected individuals progress to invasive cervical cancer. HPV type is a well established risk factor determinant for progression to cervical cancer. Over 40 HPV types infect the anogenital tract, 15 of them have been classified as high-risk for development of cervical cancer, 3 have been classified as probable high-risk, 12 have been classified as low-risk and 3 are considered undetermined-risk An HPV type is defined as a complete genome whose L1 gene sequence is at least 10% dissimilar to that of any other HPV type. Each Papillomavirus is highly tropic for a specific epithelium, and has its own degree of oncogenicity. The HPV Type-Detect® 2.0 by Bio-Plex Analysis assay is an improvement upon the current PCR technology for multiplexing by using PCR in combination with a liquid microarray system. HPV Type-Detect® 2.0 targets the L1 major capsid region. This region is a suitable target, because a diverse genetic region is contained within a more conserved region for all the detected HPV subtypes. The assay utilizes PCR to amplify a general region with subsequent detection of specific subtypes utilizing type specific oligonucleotide probes. The multiplexed assay detects and distinguishes between nineteen different subtypes, both high-risk and low-risk.
      • Method:
      • Bio-Plex Analysis
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 102 Human Papillomavirus (HPV) Subtyping (High/Low Risk of Cervical Cancer) by Real-Time PCR
    • This test has been replaced by Test 140: HPV Type-Detect® by PCR. (Oct. 4, 2006)
  • 148 Klebsiella pneumoniae by Real-Time PCR
    • Clinical significance: Klebsiella pneumoniae is a gram-negative, rod-shaped bacterium that belongs to the family Enterobacteriaceae. It is among the most common bacteria encountered by physicians worldwide and has become a well-recognized cause of nosocomial infections, such as pneumonia, urinary tract infections, wound infections and bacteremia, in immunocompromised patients. It is a common cause of human urinary tract infection when there are structural abnormalities or urethral medical instrumentation present. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 121 Leukorrhea Panel (N. gonorrhoeae, C. trachomatis, T. vaginalis) by Real-Time PCR

    • 105 Chlamydia trachomatis by Real-Time PCR
      145 Neisseria gonorrhoeae by Real-Time PCR with reflex to ciprofloxacin resistance by Pyrosequencing
      111 Trichomonas vaginalis by Real-Time PCR

    • Clinical significance: Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis are the major causes of leukorrhea. C. trachomatis is the most common sexually transmitted bacterial agent. In women, C. trachomatis causes cervicitis, urethritis, endometritis, and salpingitis. Prolonged C. trachomatis infection may result in tubal scarring, infertility, and ectopic pregnancy. Neisseria gonorrhoeae is the causative agent of the sexually transmitted disease gonorrhea. In women, the most common symptom of N. gonorrhoeae infection is endocervical infection which, if left untreated, may develop into vulvovaginitis and pelvic inflammatory disease. As a protozoan parasite, Trichomonas vaginalis is the causative agent of the sexually transmitted disease trichomoniasis. T. vaginalis infection is the primary cause of vaginitis, cervicitis and urethritis in women. Routine clinical diagnosis usually depends on microscopic identification of the parasite in wet mount preparations, which are only 60% sensitive as compared to culture-positive women. The sensitivity and specificity of PCR testing for C. trachomatis and N. gonorrhoeae are superior to the HCII (probe-based) assay which has a sensitivity/specificity of 75% / 97%, and 90.8% / 99.3%, respectively. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 136 Lymphogranuloma venereum (LGV) by Real-Time PCR

    • When sampling a crusted over lesion, moisten the swab with sterile saline solution prior to swabbing.

    • Clinical significance: Lymphogranuloma venereum (LGV) is a sexually transmitted Chlamydial disease that should be part of the differential diagnosis for any patient presenting with a genital ulcer and/or inguinal lymphadenopathy. Treatment involves the use of antibiotics to clear the infection and to prevent tertiary sequelae. LGV is caused by C. trachomatis serotypes L1, L2, and L3. C. trachomatis serovars B and D-K are associated with causing non-gonococcal urethritis and cervicitis. While these other serotypes of C. trachomatis are limited to superficial infection of mucous membranes, serotypes L1, L2, and L3 are more invasive and virulent and tend to result in systemic disease.

      LGV occurs in three distinct stages. The first stage is an incubation period of anywhere from three days to six weeks (10 to 14 days average) and is characterized by a painless genital papule which usually disappears after a few days. The onset of the second stage occurs 2 to 6 weeks later and often manifests as unilateral inguinal lymphadenopathy. Constitutional symptoms, such as fever, chills, malaise, myalgias, and arthralgias, are common in this stage of the disease. The third stage may occur years after the initial infection and is termed genitoanorectal syndrome. Women are more likely to present in this stage. Symptoms include fever, pain, tenesmus, pruritus, and purulent or bloody diarrhea. This Real-Time PCR assay is both highly sensitive and specific, capable of differentiating between LGV and C. trachomatis serotypes.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 1118 Methicillin resistant Staphylococcus aureus (MRSA) by conventional PCR
    • Clinical significance: Staphylococcus aureus, often referred to simply as "staph," are bacteria commonly carried on the skin or in the nose of healthy people. Methicillin-resistant Staphylococcus aureus (MRSA), often pronounced “mersa”, is the resistant variant of this bacteria which is resistant to ?-lactam antibiotics such as methicillin, oxacillin, penicillin, and amoxicillin. Risk of infection is greater for patients in hospitals, nursing homes, and other healthcare facilities who have open wounds and/or weakened immune systems. Colonization can occur in the anterior nares, skin, open wounds, and urinary tract. MRSA can be treated with alternate antibiotics which included glycopeptides (vancomycin and teichoplanin), linizolid, and daptomycin. Pre-screening patients upon admission for MRSA will also allow facilities to care for patients accordingly.
      • Method:
      • conventional PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 124 Mobiluncus mulieris and Mobiluncus curtisii by Real-Time PCR
    • Clinical significance: Mobiluncus mulieris and Mobiluncus curtisii are fastidious anaerobic curved Gram-variable bacteria. These bacterial species are not normal constituents of the bacterial flora and their presence in the vagina is a highly specific indicator of Bacterial Vaginosis (BV). Due to their fastidious nature and the low numbers present during BV, their absence from a vaginal specimen is not an indicator of healthy flora. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 128 Molluscum contagiosum virus (MCV) by Real-Time PCR

    • When sampling a crusted over lesion, moisten the swab with sterile saline solution prior to swabbing.

    • Clinical significance: Molluscum contagiosum virus (MCV) is a member of the human pox viruses which produces small raised papules or lesions with central umbilications and a white, firm, curd-like core. Infection occurs commonly in children under 5 years due to casual contact and in young adults due to skin-to-skin contact during sexual intercourse. MCV is a common infection in the United States and accounts for approximately 1% of all undiagnosed skin disorders. Many physician’s find it necessary to differentiate MCV from Human Papillomavirus (HPV) or Herpes simplex virus (HSV) infections, which have greater mortality and morbidity. In this assay, DNA is extracted from a swab sample of lesions actively shedding the virus or biopsies of the actual lesion and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • OneSwab®stable at room temperature; refrigerate others
      • Turn around time:
      • 24-48 hours
  • 129 Mycoplasma genitalium by Real-Time PCR
    • Clinical significance: Mycoplasmas are small (0.2 – 0.3 nm), membrane-bound organisms capable of independent self-replication. The most prevalent strains recoverable from the genital tract are Ureaplasma urealyticum, Mycoplasma hominis and Mycoplasma genitalium. Infants can become colonized with genital mycoplasmas during birth. Mycoplasma genitalium has been associated with non-gonoccocal urethritis, acute endometritis, cervicitis, and pelvic inflammatory disease (PID). Genital mycoplasma infections are usually diagnosed by culture. However, due to it’s fastidious slow-growing nature, M. genitalium may take up to 8 weeks to culture. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 130 Mycoplasma hominis by Real-Time PCR
    • Clinical significance: Mycoplasmas are small (0.2 – 0.3 nm), membrane-bound organisms capable of independent self-replication. The most prevalent strains recoverable from the genital tract are Ureaplasma urealyticum, Mycoplasma hominis and Mycoplasma genitalium. Infants can become colonized with genital mycoplasmas during birth. M. hominis has been linked to pyelonephritis, pelvic inflammatory disease (PID), spontaneous abortion, and postpartum septicemia and fever. Genital mycoplasma infections are usually diagnosed by culture. However, it can take 2 to 5 days to culture M. hominis. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 335 Mycoplasma penetrans by Real-Time PCR
    • Clinical significance: Mycoplasma species are the smallest and genetically simplest self-replicating bacteria. Mycoplasma species are ubiquitous in nature and are widely distributed throughout the animal kingdom. They have recently been associated with certain acute and chronic illnesses and can function as causative agents, cofactors, and opportunistic infectious agents. M. penetrans has been isolated from the urogenital tract and from HIV patients. It is a potential cofactor in AIDS progression. Mycoplasmas have been associated with respiratory illness, urogenital disease, immunosuppressive disease, such as HIV infection, cardiac diseases, arthritic syndromes, tick-borne illness, and chronic fatigue syndrome. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 107 Neisseria gonorrhoeae by Real-Time PCR with reflex to ciprofloxacin resistance by Pyrosequencing
    • This test has been replaced by Test 145: Neisseria gonorrhoeae by Real-Time PCR with reflex to ciprofloxacin resistance by Pyrosequencing. (December 11, 2006)
  • 145 Neisseria gonorrhoeae by Real-Time PCR with reflex to ciprofloxacin resistance by Pyrosequencing
    • Clinical significance: The incidence of drug-resistant strains of Neisseria gonorrhoeae has increased dramatically worldwide. Since 1991, when the first ciprofloxacin resistant strains were isolated, the number of resistant cases has risen to exceed 70% in some Asian countries. Fluoroquinolone-resistant strains are also on the rise in the United States and Canada. Accordingly, the number of failed treatments has risen, with 500 mg doses of ciprofloxacin demonstrating an up to 30% failure rate for gonorrheal strains having a MIC greater than 1.0 ?g/mL. Therefore, the CDC currently does not recommend the use of fluoroquinolones for the treatment of gonorrhea acquired in Asia, the Pacific Islands (including Hawaii), England, Wales, California and other locales with increased quinolone-resistant prevalences. MDL is providing, at no additional charge to the client, an analysis of two codons within the DNA gyrase gene for all N. gonorrhoeae positive OneSwab® and UroSwab® specimens. Mutations in these regions have been associated with ciprofloxacin resistance and result in the recommendation of an alternative drug treatment. In this assay, DNA is extracted from the specimen and subjected to PCR amplification allowing results to be made available to the physician significantly faster than conventional culture based methods.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours, Up to 72 hours due to reflex testing
  • 109 Neisseria gonorrhoeae, Chlamydia trachomatis by Real-Time PCR

    • 105 Chlamydia trachomatis by Real-Time PCR
      145 Neisseria gonorrhoeae by Real-Time PCR with reflex to ciprofloxacin resistance by Pyrosequencing

    • Clinical significance: Genitourinary tract infections due to C. trachomatis and N. gonorrhoeae are a major cause of morbidity in sexually active individuals. In males infections with these pathogens may cause epididymitis and urethritis. In females, they can cause pelvic inflammatory disease (PID), ectopic pregnancy, and infertility. If left untreated, Chlamydia may develop into lymphogranuloma venereum and N. gonorrhoeae may develop into a disseminated gonococcal infection (DGI). In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours; Up to 72 hours due to reflex testing
  • 1119 Panton-Valentine Leukocidin (PVL) DNA by Real-Time PCR

    • (Type IV + #1118 Req.)
      [Community Acquired MRSA = Type IV MRSA+ and PVL+]

      Only performed after a #1118 is positive for Type IV.
      Charges will be the total of tests #1118 + #1119.

    • Clinical significance: Staph infections, including MRSA, occur most frequently among persons in hospitals and healthcare facilities who have weakened immune systems. Staph and MRSA can also cause illness in persons outside of hospitals and healthcare facilities. MRSA infections that are acquired by persons who have not been hospitalized within the previous year or had a medical procedure are known as community acquired MRSA (CA-MRSA) infections. Staph or MRSA infections in the community usually manifest as skin infections, such as pimples and boils, and occur in otherwise healthy people. CA-MRSA strains were first reported in the late 1990s and were defined by a lack of exposure to the health care setting. In the next several years, it became clear that CA-MRSA infections were caused by strains of MRSA that have different genetic characteristics than other strains. Panton-Valentine leukocidin (PVL) is a cytotoxin which is associated with increased virulence of certain strains of Staphylococcus aureus. It is present in the majority [1] of community-associated Methicillin-resistant Staphylococcus aureus (CA-MRSA) isolates studied and is the cause of necrotic ("flesh-eating") lesions involving the skin or mucosa, including necrotic hemorrhagic pneumonia. The new CA-MRSA strains have rapidly spread in the United States to become the most common cause of cultured skin infections among individuals seeking medical care for these infections at emergency rooms in cities. These strains also commonly cause skin infections in athletes, jail and prison detainees, and soldiers. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • Up to 72 hours due to reflex testing
  • 138 Polyomavirus BK by Real-Time PCR
    • Clinical significance: Polyomavirus BK is a member of the Papovavirus family and infects up to 90% of the general population. After primary infection, which generally occurs in childhood without evident symptoms, the virus can remain latent in the urinary tract. Reactivation can be enhanced by immunosuppressive conditions, leading to overt clinical disease. Renal allograft recipients are particularly sensitive to reactivation as Polyomavirus BK has been implicated widely in dysfunction of the allograft. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 139 Polyomavirus JC by Real-Time PCR
    • Clinical significance: Polyomavirus JC is a double-stranded DNA virus belonging to the Papovavirus family. It is estimated that 60% to 80% of adults in Europe and the United States have antibodies to JC virus, suggesting infectivity rates are quite high. It is proposed that JC virus establishes a latent infection in the kidney after a primary infection. JC virus has been linked to the development of hemorrhagic cystitis, ureteral stenosis and allograft dysfunction in renal transplant recipients. It is also believed to be the primary causative agent of both nephropathies after transplantation and progressive multifocal leukoencephalopathy. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 362 Prevotella Species Group 1 by Real-Time PCR (P. bivia, P. disiens, P. intermedia, P. melaninogenica)
    • Clinical significance: Prevotella species are gram-negative non-motile rod-shaped singular cells that thrive in anaerobic growth conditions. Prevotella species can cause infections of the genital tract, urinary tract, wounds, bites, abscesses, bacteremia, and periodontal problems. Prevotella species involved in the Group 1 assay are Prevotella bivia, Prevotella disiens, Prevotella intermedia, and Prevotella melaninogenica. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 363 Prevotella Species Group 2 by Real-Time PCR (P. corporis, P. albensis)
    • Clinical significance: Prevotella species are gram-negative non-motile rod-shaped singular cells that thrive in anaerobic growth conditions. Prevotella species can cause infections of the genital tract, urinary tract, wounds, bites, abscesses, bacteremia, and periodontal problems. Prevotella species involved in the Group 1 assay are P. corporis and P. albensis. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 146 Proteus mirabilis by Real-Time PCR
    • Clinical significance: Proteus mirabilis, a gram-negative enteric bacterium, is one of the most common gram-negative pathogens encountered in clinical specimens and can cause a variety of community or hospital-acquired illnesses, including urinary tract, wound, and bloodstream infections. P. mirabilis is one of the most common causes of urinary tract infections (UTI) in individuals with long-term indwelling urinary catheters, complicated UTI, and bacteremia among the elderly. Individuals suffering from UTIs caused by P. mirabilis often develop bacteriuria, kidney and bladder stones, catheter obstruction due to stone encrustation, acute pyelonephritis, and fever. In this assay, DNA is extracted from the patient specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 151 Staphylococcus saprophyticus by Real-Time PCR
    • Clinical significance: Staphylococcus saprophyticus is a coagulase-negative Staphylococcus species which is implicated in 10% to 20% of urinary tract infections (UTI). In females between the ages of 17-27, it is the second most common cause of UTIs. It may also reside in the urinary tract and bladder of sexually active females. S. saprophyticus can cause UTIs in men often as a complication of bacterial infections of the prostate gland or kidney. Some of the symptoms may include a burning and frequency of urination, a 'dripping effect' after urination, weak bladder, bloated feeling with sharp razor pains in the lower abdomen around the bladder and ovary areas and razor-like pains during sexual intercourse. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 110 Treponema pallidum (syphilis) by Real-Time PCR

    • When sampling a crusted over lesion, moisten the swab with sterile saline solution prior to swabbing.

    • Clinical significance: Treponema pallidum is the causative agent of the sexually transmitted disease syphilis. The diagnosis of syphilis through traditional culture methods is complicated by the fact that T. pallidum is one of the few major bacterial pathogens of humans that cannot be cultivated on artificial medium. In this assay, we utilize a sensitive technique for T. pallidum identification that is based upon the amplification of the gene encoding the pathogen-specific and highly conserved 47-kDa membrane immunogen (tpp 47). In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 111 Trichomonas vaginalis by Real-Time PCR
    • Clinical significance: Trichomonas vaginalis, a protozoan parasite, is the causative agent of trichomoniasis. The spread of T. vaginalis is usually, but not exclusively, through sexual contact. It is a major cause of vaginitis, cervicitis, and urethritis in women and may cause nongonococcal urethritis, prostatitis, and perhaps other genitourinary tract syndromes in men. Routine clinical diagnosis usually depends on microscopic identification of the parasite in wet mount preparations. Unfortunately, wet mount examination detects only 60% of culture-positive cases in women. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 320 Ureaplasma urealyticum by Real-Time PCR
    • Clinical significance: Ureaplasma, of the family Mycoplasmataceae, are among the smallest free-living bacteria. Colonization, the presence and multiplication of microorganisms without tissue invasion or damage, usually begins at birth with passage through an infected mother’s birth canal. Ureaplasmas have been isolated from the genital tract of 33% of infant girls and from the noses and throats of 15% of infant boys and girls. Carriage of these organisms does not usually persist beyond the age of 2. However, a small portion of pre-pubescent children will remain colonized and asymptomatic. As a result of sexual contact, the incidence of genital Ureaplasmas increases after puberty. In some pregnant women, Ureaplasma infections are considered to be the cause of chorioamnionitis and premature delivery. They are frequently transmitted from mothers to their infants, which may cause a variety of disorders including pneumonia, persistent pulmonary hypertension, and chronic infection of the central nervous system. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 575 Urogenital Candidiasis Panel by Real-Time PCR

    • 551 Candida albicans by Real-Time PCR
      557 Candida tropicalis by Real-Time PCR
      558 Candida parapsilosis by Real-Time PCR

    • Clinical significance: Mycoplasmas are small (0.2 – 0.3 nm), membrane-bound organisms capable of independent self-replication. The most prevalent strains recoverable from the genital tract are Ureaplasma urealyticum, Mycoplasma hominis and Mycoplasma genitalium. Infants can become colonized with genital mycoplasmas during birth. After puberty, colonization with mycoplasmas occurs primarily through sexual contact. Genital mycoplasmas are commonly isolated from gravid women at approximately the same recovery rate as in nonpregnant women with the same degree of sexual activity. Mycoplasmas and Ureaplasmas are strongly associated with infertility, intraamnionic infection, postpartum infection, pelvic inflammatory disease (PID), and histologic chorioamnionitis. Genital mycoplasma infections are usually diagnosed by culture. However, it can takefrom 2 to 5 days or up to 8 weeks to culture M. hominis and M. genitalium, respectively. Subspeciation of human urogenital mycoplasma infections is paramount for successful antimicrobial therapy due to differential antimicrobial susceptibilities. In this assay, DNA is extracted from the specimen and subjected to PCR amplification using a highly sensitive and specific PCR based assay developed by MDL that can differentiate among these Mycoplasma species.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 134 Urogenital Mycoplasma & Ureaplasma Panel by Real-Time PCR

    • 129 Mycoplasma genitalium by Real-Time PCR
      130 Mycoplasma hominis by Real-Time PCR
      320 Ureaplasma urealyticum by Real-Time PCR

    • Clinical significance: Mycoplasmas are small (0.2 – 0.3 nm) membrane bound organisms capable of independent self-replication. The most prevalent strains recoverable from the genital tract are Ureaplasma urealyticum, Mycoplasma hominis and Mycoplasma genitalium. Infants can become colonized with genital mycoplasmas during birth. After puberty, colonization with mycoplasmas occurs primarily through sexual contact. Genital mycoplasmas are commonly isolated from gravid women at approximately the same recovery rate as in nonpregnant women with the same degree of sexual activity. Mycoplasmas and Ureaplasmas are strongly associated with infertility, intraamnionic infection, postpartum infection, pelvic inflammatory disease (PID), and histologic chorioamnionitis. Genital mycoplasma infections are usually diagnosed by culture. However, it can take from 2 to 5 days or up to 8 weeks to culture M. hominis and M. genitalium, respectively. Subspeciation of human urogenital mycoplasma infections is paramount for successful antimicrobial therapy due to differential antimicrobial susceptibilities. In this assay, DNA is extracted from the specimen and subjected to PCR amplification using a highly sensitive and specific PCR based assay developed by MDL that can differentiate among these bacterial species.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 131 Urogenital Mycoplasma Panel by Real-Time PCR

    • 129 Mycoplasma genitalium by Real-Time PCR
      130 Mycoplasma hominis by Real-Time PCR

    • Clinical significance: Mycoplasmas are small (0.2 – 0.3 nm), membrane-bound organisms capable of independent self-replication. The most prevalent strains recoverable from the genital tract are Ureaplasma urealyticum, Mycoplasma hominis and Mycoplasma genitalium. Infants can become colonized with genital mycoplasmas during birth. After puberty, colonization with mycoplasmas occurs primarily through sexual contact. Genital mycoplasmas are commonly isolated from gravid women at approximately the same recovery rate as in nonpregnant women with the same degree of sexual activity. Mycoplasmas and Ureaplasmas are strongly associated with infertility, intraamnionic infection, postpartum infection, pelvic inflammatory disease (PID), and histologic chorioamnionitis. Genital mycoplasma infections are usually diagnosed by culture. However, it can take from 2 to 5 days or up to 8 weeks to culture M. hominis and M. genitalium, respectively. Subspeciation of human urogenital mycoplasma infections is paramount for successful antimicrobial therapy due to differential antimicrobial susceptibilities. In this assay, DNA is extracted from the specimen and subjected to PCR amplification using a highly sensitive and specific PCR based assay developed by MDL that can differentiate among these Mycoplasma species.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours
  • 127 Vaginal Group B Strep by Real-Time PCR

    • Obtaining specimens from both the anorectum and distal vagina increases the sensitivity of testing by a considerable percentage (5% to 25%) over vaginal swabbing alone.

    • Clinical significance: Group-B Streptococcus is the leading cause of neonatal infections, which can result in septicemia, pneumonia and meningitis. It is the most common cause of life-threatening infection in newborns. One out of every twenty babies with GBS dies from the infection. In pregnant women, GBS can cause bladder infections, womb infections, and stillbirths. Most adults are asymptomatic carriers of GBS in the bowel, vagina, bladder or throat. Diagnosis by traditional cultures may take several days to complete. Once diagnosed, GBS can be treated with antibiotics to prevent the spread from mother to baby. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • 24-48 hours
  • 137 Vaginal Group B Strep (GBS) Antibiotic Resistance by Real-Time PCR

    • This test is for patients that are penicillin-allergic and sensitivities are required. Only performed after a #127 is positive. Charges will be the total of tests #127 + #137.

    • Clinical significance: The typical treatment for Group B Streptococcus-infected patients is penicillin G, of which there is no known resistance. However, up to 12% of the population reports allergies to penicillin. Therefore the macrolide (erythromycin) or lincosamide (clindamycin) classes of drugs need to be administered, particularly for those patients who are at high risk for anaphylactic shock. Previous reports cite an increase in resistance of GBS to erythromycin and clindamycin. For instance, in 2003, resistance to erythromycin and clindamycin was reported to be as high as 37% and 17%, respectively.

      The antibiotic resistance mechanisms are most commonly caused by three genes: ermB, ermTR, and mefA. MDL published a study where both the Clinical and Laboratory Standards Institute (formerly NCCLS) 2003 “Performance Standards for Antimicrobial Susceptibility Testing” protocols and a multiplex PCR assay were used to screen for the prevalence of these genes in 222 GBS clinical isolates (Gygax et al. 2006).These isolates were obtained from MDL’s clinical swab samples which were procured with the OneSwab® collection system. Of the 222 GBS clinical isolates, 84 strains (38%) were resistant to erythromycin and 46 strains (21%) were resistant to clindamycin. The multiplex PCR proved to be an efficient method to identify the three major antibiotic resistance genes in GBS. With the presence of these genes on mobile genetic elements, such as plasmids and/or transposons, the passing of these genes from bacteria to bacteria is likely and should be monitored to provide the physician with the vital information needed for proper patient treatment.

      MDL has developed a highly sensitive (94%) and (99%) specific multiplex polymerase chain reaction to identify GBS antibiotic resistance genes from GBS clinical isolates.

      • Method:
      • Real-Time PCR
      • Transport:
      • Stable at room temperature
      • Turn around time:
      • Up to 72 hours due to reflex testing
  • 215 Varicella-zoster virus (VZV) by Real-Time PCR

    • When sampling a crusted over lesion, moisten the swab with sterile saline solution prior to swabbing.

    • Clinical significance: Varicella-Zoster Virus (VZV), also known as HHV3, is a member of the neurotrophic alpha herpesvirus family, which is considered to be the most infectious of the human herpes viruses. The alpha herpesviruses’ possess factors that increase their infectivity, including short reproductive cycles, the ability to replicate in multiple cell types and the ability to induce high levels of host cell tissue destruction quite rapidly. Humans serve as the alpha herpesviruses’ only natural reservoir, which means transmission is person-to-person through either the aerosolization of virus in nasopharyngeal secretions or more directly by contact with vesicle fluids or respiratory secretions. Primary infections result in chickenpox and 95% occur during childhood. Presenting symptoms include rash, low-grade fever, headaches and malaise. Patients with chickenpox remain infective until the last skin lesion has dried and crusted over. Those who are infected during adulthood experience a greater number of complications and account for nearly half of all chickenpox-related deaths. Neonates and pregnant women are particularly susceptible to severe primary VZV infections. Complications associated with VZV infection include bacterial superinfections of the skin and lower respiratory tract. Diagnosis is typically based on clinical presentation, but in some instances, particularly immunocompromised individuals, clinical evaluation is necessary. Because VZV is capable of establishing a latent state within the sensory ganglia, infection is life-long and viral reactivation in the form of shingles or Ramsay Hunt Syndrome is possible at any age. Shingles occur in approximately 20% of the adult population at least once in their lives, with 1% experiencing multiple reactivations. Vaccination with the live attenuated Oka strain of VZV, Varivax, is available and recommended for adults over the age of sixty for the prevention of shingles. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.
      • Method:
      • Real-Time PCR
      • Turn around time:
      • 24-48 hours

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Medical Diagnostic Laboratories, L.L.C.
2439 Kuser Road
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 Hamilton, NJ 08690
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