Sexual Health & STDs

Sexual Health & STDs

Hepatitis B surface antigen (HBsAg) is a distinctive serological marker of acute or chronic hepatitis B infection. HBsAg is the first antigen to appear following infection with HBV and is generally detected 1-10 weeks after the onset of clinical symptoms. HBsAg assays are routinely used to diagnose suspected HBV infection and monitor the status of infected individuals to determine whether the infection has resolved or the patient has become a chronic carrier of the virus. In patients that recover from HBV infection, HBsAg is undetectable 3-5 months after the onset of infection. In patients with chronic HBV infection, HBsAg remains detectable for life. Prenatal HBsAg screening has been recommended so that newborns from HBV carrier mothers may obtain prophylactic treatment. Persistence of HBsAg, without anti-HBs, with combinations of positivity of anti-HBc, HBeAg, or anti-HBe indicates infectivity and need for investigation for chronic persistent or chronic aggressive hepatitis.

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Hepatitis B core antigen (HBcAg), found in liver cells, does not circulate in the bloodstream. However, IgM and IgG antibodies to HBcAg can be detected serologically in HBV infected individuals. Anti-HBc IgM is detectable first and remains detectable for approximately six months. Shortly after the IgM response, anti-HBc IgG appears and can remain detectable indefinitely. The presence of anti-HBc IgM and anti-HBc IgG is characteristic of acute infection, while the presence of anti-HBc IgG without anti-HBc IgM is characteristic of chronic or recovered stages of HBV infection. Anti-HBc Total assays detect both IgM and IgG anti-HBc responses. Most often levels of anti-HBc will coincide with detectable levels of other HBV markers. Rarely, anti-HBc may be the only detectable HBV marker. This may occur during the brief period when hepatitis B surface antigen (HBsAg) has been cleared from the bloodstream and before antibodies to hepatitis B surface antigen (anti-HBs) become detectable. For this reason, the use of anti-HBc Total assays to detect acute infection is not recommended. Anti-HBc Total assays should be used in conjunction with other marker assays to assess current or past exposure to HBV.

Sexual Health & STDs

Anti-HBs usually can be detected several weeks to several months after HBsAg is no longer found, and it may persist for many years or for life after acute infection has been resolved. It may disappear in some patients, with only antibody to core remaining. Patients with this antibody are not overtly infectious. Presence of the antibody without the presence of the antigen is evidence for immunity from reinfection, with virus of the same subtype.

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Treponemal antibody (CIA)RPRRPR titerTreponemal antibody (TPPA)InterpretationNonreactiveNot doneNot doneNot doneNo laboratory evidence of syphilis. If recent exposure is suspected, submit a new sample for testing in 2-4 weeks.ReactiveNonreactiveNot doneNonreactiveTreponemal antibodies not confirmed. Inconclusive for syphilis; potentially early syphilis, possible false positive. If recent exposure is suspected, submit a new sample for testing in 2-4 weeks. If clinical suspicion is low no further evaluation is necessary.ReactiveNonreactiveNot doneReactiveTreponemal antibodies detected. Consistent with past or current (potentially early) syphilis. Clinical evaluation should be performed to identify current signs and symptoms or past history of infection. If past history of treatment reported, no further management is needed unless symptomatic or recent exposure suspected. If no symptoms or past history of treatment, and if recent exposure is suspected, submit a new sample for testing in 2-4 weeks.ReactiveReactive1:1 or greaterNot doneTreponemal and nontreponemal antibodies detected. Consistent with past or current syphilis. Clinical evaluation should be performed to identify current signs and symptoms or past history of infection.

Sexual Health & STDs

Hepatitis A virus (HAV) is a picornavirus primarily transmitted via the fecal-oral route. HAV replicates in the liver and is shed in high concentrations in feces from 2-3 weeks before to 1 week after the onset of clinical illness. IgM antibody typically becomes detectable within 5-10 days of the onset of symptoms, usually peaks within 1 month of illness, and decreases to undetectable levels within 6 months of infection. Many cases of HAV are subclinical, particularly in children. Antibody produced in response to HAV infection persists for life and confers protection against reinfection. The presence of IgM antibody to HAV is diagnostic of acute HAV infection. A positive test for total anti-HAV indicates immunity to HAV infection but does not differentiate active from resolved HAV infection. Although usually not sensitive enough to detect the low level of protective antibody after vaccination, anti-HAV tests also might be positive after hepatitis A vaccination.

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IgM antibodies to Hepatitis A suggest a current, acute or recent Hepatitis A infection.

Sexual Health & STDs

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Sexual Health & STDs, Infectious Diseases

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Sexual Health & STDs, Infectious Diseases

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Sexual Health & STDs

Set up and reported Monday thru Friday.

Sexual Health & STDs

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Sexual Health & STDs

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Sexual Health & STDs

Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningoencephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.

Sexual Health & STDs

Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningoencephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.

Sexual Health & STDs

This assay does not distinguish between Total B Core Antibody IgG and IgM detected before or at the onset of symptoms; however, such reactivity can persist for years after illness, and may even outlast anti-HBS. Occasionally Hepatitis B Core Antibody may be the only marker of either current or past Hepatitis B infection. HBV vaccination leads to development of HBsAb but not to HBcAb.

Sexual Health & STDs

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Sexual Health & STDs

This is a non-treponemal screening test for syphilis. False positive results may occur due to systemic lupus erythematosus, leprosy, brucellosis, atypical pneumonia, typhus, yaws, pinta, or pregnancy. Monitoring of RPR is helpful in assessing effectiveness of therapy.

Infectious Diseases, Sexual Health & STDs

Varicella-Zoster Virus (VZV) causes chicken pox and when reactivated, potentially decades later, causes shingles. Twenty percent of adults will develop shingles, a rash or blister of the skin that may cause severe pain. Varicella-Zoster IgG, EIA reliably measures immunity due to previous infection, but is unsuitable for detection of post-vaccination immune status.

Infectious Diseases, Sexual Health & STDs

Surface antigen usually appears in the serum after an incubation period of 1 to 6 months following exposure to Hepatitis B virus and peaks shortly after onset of symptoms. It typically disappears within 1 to 3 months. Persistence of Hepatitis B Surface Antigen for greater than 6 months is a prognostic indicator of chronic Hepatitis B infection.

Sexual Health & STDs

This assay is used to determine immune status for Hepatitis B as ≥10 mIU/mL as per CDC Guidelines.

Sexual Health & STDs

Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningoencephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV Type 2 is more commonly associated with genital tract and neonatal infections, while HSV Type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.

Sexual Health & STDs, Infectious Diseases

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Sexual Health & STDs, Infectious Diseases

UreaplasmaandMycoplasmacan be isolated from urethral and genital swabs and from urine of sexually active individuals. Sixty percent or more of all women asymptomatically carryU urealyticumin their genital tract. Usual prevalence of these organisms in patients with urethral symptoms also is high; thus, conclusions regarding the etiologic role of an isolate in a given patient are difficult to make. Nevertheless,Ureaplasma urealyticumhas been associated with cases of nongonococcal urethritis.

Sexual Health & STDs, Infectious Diseases

This is a non-treponemal screening test for syphilis. False positive results may occur due to systemic lupus erythematosus, leprosy, brucellosis, atypical pneumonia, typhus, yaws, pinta, or pregnancy. Monitoring of RPR is helpful in assessing effectiveness of therapy.

Sexual Health & STDs

Anti-HBc IgM increases rapidly, peaks during the acute infection stage of HBV infection, and then falls to a relatively low level as the patient recovers or becomes a chronic carrier. Anti-HBc IgM is useful in the diagnosis of acute HBV infection even when HBsAg concentrations are below the sensitivity of the diagnostic assay. The presence of anti-HBc IgM and anti-HBc IgG is characteristic of acute infection, while the presence of anti-HBc IgG without anti-HBc IgM is characteristic of chronic or recovered stages of HBV infection. The use of other viral markers such as HBsAg, anti-HBs, and anti-HBc total to differentiate acute from chronic hepatitis B is inconclusive because most of these markers are alsoseen in chronic infection.

Sexual Health & STDs

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Sexual Health & STDs

Hepatitis B core-specific IgM class antibody has been detected in most acute infections and is a reliable marker for acute disease. In some cases, hepatitis B core IgM antibody may be the only specific marker for the diagnosis of acute infection with hepatitis B virus.

Sexual Health & STDs

The detection of anti-HBs is indicative of a prior immunologic exposure to the antigen or vaccine. To determine immune status as ≥10 mIU/mL as per CDC guidelines, please order Hepatitis B Surface Antibody, Quantitative.

Sexual Health & STDs

The appearance of anti-HBe in patients who have previously been HBeAg positive indicates a reduced risk of infectivity. Failure of appearance implies disease activity and probable chronicity but patients with HBeAb may have chronic hepatitis. Chronic HBsAg carriers can be positive for either HBeAg or anti-HBe, but are less infectious when anti-HBe is present. HBe can persist for years, but usually disappears earlier than anti-HBs or anti-HBc. Anti-HBe has not been found as the sole serologic marker for hepatitis B infection.

Sexual Health & STDs

HBe antigen becomes detectable shortly after HBsAg is detectable and is an indicator of active infection and replicating virus. The disappearance of HBeAg and the appearance of anti-HBe together with other HBV markers allow the clinician to determine a prognosis, and to follow the progression of the disease from acute to chronic or recovered status.

Sexual Health & STDs

HBeAb appears in the early convalescence of HBV infection. With carrier state and chronic hepatitis, HBeAb may not develop.

Infectious Diseases, Sexual Health & STDs

Hepatitis C Virus (HCV) is a major cause of hepatitis. The clinical symptoms of an HCV infection are variable. Infection with HCV results in a chronic infection in 50 to 80% of cases. The "window" between HCV acquisition and seroreactivity is highly variable; up to six months.

Sexual Health & STDs

HBeAg indicates active HBV replication. Infectivity is evaluated based on HBeAg and HBsAg. When HBeAg persists much longer than 10 weeks, the patient is likely to develop chronic hepatitis and be a carrier.

Sexual Health & STDs, Infectious Diseases

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See table.HAV antibody testing interpretation chartHAV Total AntibodyHAV IgMCommentsNegativeNot doneNo evidence of vaccination or previous infection;Susceptible to Hepatitis A infectionPositiveNot doneConsistent with recent or remote Hepatitis A infection or antibody response to HAV vaccinationPositiveNegativeConsistent with resolved Hepatitis A infection or antibody response to HAV vaccinationPositivePositiveConsistent with active Hepatitis A infection

Sexual Health & STDs

HAV antibody indicates prior or acute infection with, or immunization to, Hepatitis A virus.

Sexual Health & STDs

Individuals with the antiphospholipid antibody syndrome (APS) have an increased risk for stroke, myocardial infarction, venous thrombosis, thromboembolism, thrombocytopenia, and/or recurrent miscarriages. In 1999, an international consensus conference found that one criterion for the serologic diagnosis of “definite antiphospholipid syndrome” is the presence of anticardiolipin antibody of IgG and/or IgM isotype, at medium or high titer, on two or more occasions, at least 6 weeks apart.3The presence of ACA of moderate to high titer for IgG is strongly associated with both arterial and venous thrombosis and recurrent pregnancy loss.2,4,5The IgM isotype of ACA has also been shown to be associated with venous thrombosis.4Other studies found that ACA of the IgA isotype at moderate to high titer can also be associated with increased risk of APS.2,6ACA antibodies are quite common in the general population and are not always associated with APS. Studies indicate that there is a higher prevalence of IgM positives than IgG in the general population with these isotypes occurring in 9.4% and 6.5% of the population, respectively.7The incidence of these ACA is even higher in normal pregnancy with detection rates of 17% for IgM and 10.6% for IgG.8Many of these antibodies are transient and not associated with APS. The diagnosis of APS should not be made on the basis of a single ACA result but rather on repeated positive results obtained at least six weeks apart.1The Venereal Disease Research Laboratory (VDRL) agglutination test that has been used for decades in the diagnosis of syphilis is based on the detection of antibodies to cardiolipin.9The first solid-phase immunoassays for ACA were developed in the early 1980s.9These solid-phase assays are at least 100-fold more sensitive than the classical VDRL assay and produce many more positive results. In general, ACA are considered to be more sensitive than lupus anticoagulants (LA) for the detection of APS.4The ACA test is positive in 80% to 90% of patients with APS,10and ACA are implicated in approximately five times more cases of APS than are LA;2however, LA are considered to be more specific for APS than ACA.2,10Due to the heterogeneity of antibodies associated with APS, both LA and ACA testing is recommend when APS is suspected.4,11ACA are frequently observed in patients with other autoimmune disorders and malignancies. Individuals with ACA secondary to these other conditions are at increased risk of developing APS. A variety of therapeutic drugs can induce the production of ACA. These drug-induced antibodies may be clinically significant if they persist.2,12

Sexual Health & STDs

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Sexual Health & STDs

HIV-1 infection results in a decrease of CD4 T cells, an increase of CD8 T cells, a decrease in the CD4:CD8 ratio, and a progressive destruction of immune function. In HIV-1 seropositive patients, enumeration of CD4 T cells may be used for prognostic purposes and to monitor disease progression and antiretroviral therapy.

Sexual Health & STDs

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Infectious Diseases, Sexual Health & STDs

Varicella-Zoster Virus (VZV) causes chicken pox and when reactivated, potentially decades later, causes shingles. Twenty percent of adults will develop shingles, a rash or blister of the skin that may cause severe pain.

Sexual Health & STDs

The FTA-ABS is a specific treponemal assay to detect antibody toT. pallidum.The FTA-ABS becomes reactive 4-6 weeks after infection. Unlike the nontreponemal tests, once the FTA-ABS test becomes reactive, it will remain reactive for many years. Since the reactivity found with the FTA-ABS does not indicate response to therapy, it is not suitable for monitoring treatment. The FTA-ABS test does not distinguish between syphilis and other treponematoses such as yaws, pinta and bejil.

Sexual Health & STDs

This assay detects presence of both IgG and IgM antibodies to the hepatitis B core (anti-HBc) antigen. If positive, it reflexes to further detect only the presence of IgM anti-HBc. When both the total anti-HBc and IgM anti-HBc are positive, it is indicative of acute HBV infection. A positive total anti-HBc with negative IgM anti-HBc is indicative of either acute or past Hepatitis B infection. Total anti-HBc may be the only HBV marker detected in past infection. Anti-HBc antibodies, both total and IgM, are absent from HBV vaccinated people.

Sexual Health & STDs

Primary infection by EBV causes infectious mononucleosis, usually a self-limiting disease in children and young adults. Infection with EBV can cause lymphoproliferative disorders including tumors. IgG recognizing Early Antigen D typically appears within a month after clinical presentation and is transient, lasting only 3-4 months. Persistently elevated levels suggest reactivation or persistence of EBV infection.

Sexual Health & STDs

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Sexual Health & STDs

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Sexual Health & STDs

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Sexual Health & STDs

This test is intended to be used as the primary screening test for the diagnosis of infection withChlamydia trachomatisorNeisseria gonorrhoeaeand is required for screening all potential semen or egg donors for in vitro fertilization or other reproductive procedures; reactive results may be sufficient to consider a donor ineligible.

Sexual Health & STDs

C. trachomatisinfections are the leading cause of sexually transmitted diseases in the United States.C. trachomatisis known to cause cervicitis, pelvic inflammatory disease (PID), epididymitis and proctitis. It is also the most frequent cause of non-gonococcal urethritis in men. Among women, the consequences ofChlamydialinfections are severe if left untreated. Approximately half ofChlamydialinfections are asymptomatic.⁠⁠⁠⁠⁠⁠⁠Neisseria gonorrhoeae(gonococci) is the causative agent of gonorrhea. In men, this disease generally results in anterior urethritis accompanied by purulent exudate. In women, the disease is most often found in the cervix, but the vagina and uterus may also be infected.

Sexual Health & STDs

Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningoencephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.

Sexual Health & STDs

Candidiasis is a fungal infection that may cause localized or systemic disease. The severity of infection is broad extending to life threatening. Acute or convalescent titers should be compared.

Sexual Health & STDs, Infectious Diseases

Identification ofTreponema pallidumantibodies may aid in the diagnosis of syphilis.

Sexual Health & STDs

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Sexual Health & STDs

HHV-6 is a distinct herpes virus that typically causes a self-limiting illness in patients who are not immunocompromised. In some patients, especially if immumocompromised, HHV-6 can cause febrile convulsions in infants, encephalitis mononucleosis-like symptoms, and hepatitis.

Sexual Health & STDs

This panel may be helpful in the diagnosis of acute or recent infection with hepatitis A virus (HAV), hepatitis B virus (HBV), and hepatitis C virus (HCV), the 3 most common pathogens of viral hepatitis in the United States [1].Acute symptoms and signs are similar among HAV, HBV, and HCV infection and may include fever, fatigue, loss of appetite, nausea, abdominal discomfort, dark urine, pale stools, and jaundice [1-4]. This panel may help establish diagnosis of these 3 viral hepatitis infections in symptomatic patients.This panel includes 4 tests with reflexes: HAV IgM antibody, hepatitis B surface antigen (HBsAg) with reflex to confirmation, hepatitis B core IgM antibody (HBcAb IgM), and HCV antibody with reflex to HCV RNA quantitative real-time PCR.The section below outlines the roles of the analytes assessed with this panel.HAV IgM: Presence indicates current or recent infection or recent vaccination. A negative result indicates absence of acute infection [2].HBsAg with reflex confirmation: Presence indicates that a person has a current HBV infection and is infectious [3].HBcAb IgM: Presence indicates HBV infection within the preceding 4 to 6 months (ie, acute/recent infection) [3].HCV antibody with reflex to HCV RNA: Presence (with detectable HCV RNA) indicates current infection. A positive result with a "not detected" HCV RNA reflex result may indicate a resolved infection or a biological false-positive antibody screening test [4].The results of the test in the panel should be interpreted in the context of pertinent clinical history and physical examination findings.References1. Viral Hepatitis Surveillance - United States, 2019. Centers for Disease Control and Prevention. Accessed January 16, 2021.https://www.cdc.gov/hepatitis/statistics/2019surveillance/pdfs/2019HepSurveillanceRpt.pdf2. Nelson NP, et al.MMWR Recomm Rep. 2020;69(5):1-38.3. Roush SW, et al. Chapter 22: laboratory support for surveillance of vaccine-preventable diseases. In: Roush SW, et al, eds.Manual for the Surveillance of Vaccine-Preventable Diseases.Centers for Disease Control and Prevention. Reviewed June 3, 2021. Accessed January 16, 2022.https://www.cdc.gov/vaccines/pubs/surv-manual/chpt22-lab-support.html4. Centers for Disease Control and Prevention.MMWR Morb Mortal Wkly Rep. 2013;62(18):362-365.

Infectious Diseases, Sexual Health & STDs

Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningoencephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.

Infectious Diseases, Sexual Health & STDs

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Infectious Diseases, Sexual Health & STDs

In patients who are immunocompromised, CMV may cause disseminated, severe disease. CMV is also the most common cause of congenital viral infection in humans. Quantitative PCR methods may be useful in monitoring CMV replication in immunosuppressed patients. This is a quantitative molecular test, with a linear range of 34.5-10,000,000 IU/mL (1.54-7.00 log IU/mL).

Sexual Health & STDs

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Sexual Health & STDs

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Sexual Health & STDs

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Sexual Health & STDs

Chlamydophila pneumoniaeis a common cause of infantile and community-acquired pneumonia.

Sexual Health & STDs

Chlamydia trachomatisis the most common sexually transmitted bacterial infection. Up to 70% of women and 30% of men may be asymptomatic. Infection may lead to tubal pregnancy, pelvic inflammatory disease and infertility. Other organs may also become affected.

Sexual Health & STDs

HIV-1 DNA PCR is a sensitive method for detection of pro-viral DNA. It has been used in the management of perinatal HIV infection. HIV-1 RNA has recently been confirmed equally as sensitive and specific for this purpose.

Sexual Health & STDs

C. trachomatisis associated with infections of the mucous membranes of the urogenital system, the upper respiratory tract and the eye. It may be sexually transmitted; resulting diseases include urethritis, cervicitis, salpingitis, epididymitis, proctitis and lymphogranuloma venereum.C. pneumoniaeis associated with both upper and lower respiratory infections. Infections of the upper respiratory tract and eye usually occur in newborns exposed at parturition. In adults, eye infection may be transmitted by hand after contact with secretions. Isolation by tissue culture is recommended when testing individuals for legal purposes.

Sexual Health & STDs

Neisseria gonorrhoeaeis considered a pathogen whenever isolated and its identification is important in initiating appropriate therapy to prevent the spread of the infection as well as the serious sequelae.

Sexual Health & STDs

This assay is intended for the qualitative detection ofChlamydia trachomatisandNeisseria gonorrhoeaein ocular (conjunctival) specimens from patients suspected of having infectious conjunctivitis caused byC. trachomatisorN. gonorrhoeae. It does not detectChlamydophila (Chlamydia) pneumoniaeor otherChlamydiaspecies.C. trachomatisandN. gonorrhoeaeare two of the most common causes of sexually transmitted infections, and both organisms can cause infectious conjunctivitis. Newborns are especially at risk forC. trachomatisorN. gonorrhoeaeconjunctivitis if born to a mother with a genital infection.Symptoms ofC. trachomatisorN. gonorrhoeaeconjunctivitis may include eye redness, eye lid swelling, and discharge. Symptoms in newborns infected at birth typically appear within two weeks.A Not Detected (negative) result means thatC. trachomatisorN. gonorrhoeaeRNA was not present in the specimen above the limit of detection. A negative result does not rule out the possibility of infection and should not be used as the sole basis for patient management decisions.1. CDC Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR July 23, 2021.2. Conjunctivitis (Pink Eye) in Newborns. Centers for Disease Control and Prevention. Last Reviewed: January 4, 2019.https://www.cdc.gov/conjunctivitis/newborns.html#:~:text=Conjunctivitis%20(Pink%20Eye)%20in%20Newborns&text=Newborns%20with%20symptoms%20of%20conjunctivitis,conjunctivitis%20can%20be%20very%20serious3. Kreisel, K. et al. Keeping an Eye on Chlamydia and Gonorrhea Conjunctivitis in Infants in the United States, 2010-2015. Sex Transm Dis. 2017 Jun; 44(6): 356-358.

Sexual Health & STDs

The assay is intended to aid in the diagnosis of vaginitis using clinician-collected and patient-collected vaginal swab specimens from individuals with a clinical presentation consistent with vaginitis. Testing for bacterial vaginosis (BV), vulvovaginal candidiasis and trichomoniasis, as well asChlamydia trachomatisandNeisseria gonorrhoeaeis included.The BV test is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), includingLactobacillus(L. gasseri, L.crispatus, andL. jensenii),Gardnerella vaginalis, andAtopobium vaginae. The assay reports a qualitative result for BV and does not report results for individual organisms.For vulvovaginal candidiasis and trichomoniasis, a real time transcription-mediated amplification (TMA) assay is used to detect and qualitatively report results forCandida speciesgroup (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis, C. glabrata), andTrichomonas vaginalis.ForChlamydia trachomatisandNeisseria gonorrhoeae, A target capture assay for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) fromChlamydia trachomatisand/orNeisseria gonorrhoeaeis utilized.

Sexual Health & STDs, Women's Health

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Sexual Health & STDs

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Sexual Health & STDs

This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment.

Sexual Health & STDs

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Sexual Health & STDs

This test is used to determine the presence of HHV-6 DNA in patients' specimens. Organisms may be detected by PCR prior to detection by immunological methods. PCR provides more rapid results than other methods, including culture.

Sexual Health & STDs

Detection of treponemal antibodies may indicate recent, past, or successfully treated syphilis infections, therefore, the test cannot be used to differentiate between active and cured cases. A reactive syphilis antibody test result may be used to disqualify a potential blood, cell or tissue donor.

Sexual Health & STDs

The TP-PA test is designed to be used as an aid in the confirmation of antibodies to the treponemal organisms that cause syphilis. Other diseases such as yaws or pinta give positive results.

Sexual Health & STDs

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Sexual Health & STDs

Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from mild to fatal. Herpes Simplex Virus Type 1 infection are usually found above the waist. Herpes Simplex Virus Type 2 infections are more commonly seen in association with the genitalia, and surrounding areas, and are usually sexually transmitted. It is important to note however, that both Herpes Simplex types 1 and 2 have been involved in all disease manifestations and locations of the body, following introduction of the virus through broken skin or mucous membranes.

Sexual Health & STDs

This test is designed to be used as an aid in the confirmation of antibodies to the treponemal organisms that cause syphilis in the context of a positive non-treponemal assay. It is not intended to be used as a standalone for diagnosis. For algorithm based syphilis testing, please see TC 90349 Syphilis Antibody Cascading Reflex or TC 36126 RPR (Diagnosis) with Reflex to Titer and Confirmatory Testing.

Sexual Health & STDs

⁠⁠⁠⁠⁠⁠⁠Human herpesvirus 8 (HHV-8) is associated with the development of all forms of Kaposi's Sarcoma as well as with some other rare lymphoproliferative diseases, such as primary effusion lymphoma and multicentric Castleman's disease. Qualitative PCR is often used to aid in diagnosis of an HHV-8 infected individual.

Sexual Health & STDs

RPR is a nontreponemal (lipoidal antigen) test used to screen for syphilis. Positive RPR samples are reflexed to determine titer and to a confirmatory treponemal assay as part of the traditional algorithm. False positive results associated with various medical conditions, including other infections (e.g., HIV), autoimmune conditions, vaccinations, injecting drug use, pregnancy, and older age may occur with the RPR test.This assay may be performed as part of an overall screening regimen for patients considering or who are currently taking HIV PrEP. Please refer to the "Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2021 Update Clinical Practice Guideline" for additional information.

Sexual Health & STDs

This test is used in the diagnosis of human herpesvirus 7 infection. HHV-7 is closely related to HHV-6 and CMV and can reactivate in transplant patients or other immune-compromised individuals. PCR may detect infection earlier than immunological methods and provides more rapid results than culture, but does not provide information on past exposure or immunity. Quantitative measurement may provide information on disease regression. Reportable range is 500 to 10,000,000 copies/mL (2.70 to 7.00 Log copies/mL).

Sexual Health & STDs

This panel includes nucleic acid amplification testing for HSV-1, HSV-2, andTreponema pallidumin genital lesion swabs. Due to the overlapping clinical presentation of herpetic and syphilitic lesions, this panel can be used to aid in the identification of the most common etiological agents causing genital ulcer disease. A positive result is definitive diagnosis for the causative agent and a negative result may require additional testing.

Sexual Health & STDs

This test is used to determine the presence of HHV-6 DNA in patients' specimens. Organisms may be detected by PCR prior to detection by immunological methods. PCR provides more rapid results than other methods, including culture. Reportable range is 500 to 2,000,000 copies/mL (2.70 to 6.30 Log copies/mL).

Sexual Health & STDs

This test is used to determine the presence of HHV-6 DNA in patients' specimens. Organisms may be detected by PCR prior to detection by immunological methods. PCR provides more rapid results than other methods, including culture.

Sexual Health & STDs

Human herpesvirus-8 (HHV-8) is associated with the development of all forms of Kaposi's sarcoma, as well as with some other rare lymphoproliferative diseases, such as primary effusion lymphoma and multicentric Castleman's disease. Quantitative PCR may be used to monitor the level of viremia in a patient, often in the context of therapy. Reportable range is 1,000 to 10,000,000 copies/mL (3.00 to 7.00 Log copies/mL).

Sexual Health & STDs

Human herpesvirus-8 (HHV-8) is associated with the development of all forms of Kaposi's sarcoma, as well as with some other rare lymphoproliferative diseases, such as primary effusion lymphoma and multicentric Castleman's disease. Quantitative PCR may be used to monitor the level of viremia in a patient, often in the context of therapy. Reportable range is 1,000 to 10,000,000 copies/mL (3.00 to 7.00 Log copies/mL).

Sexual Health & STDs

Positive results are suggestive of neurosyphilis.

Infectious Diseases, Sexual Health & STDs

This test is used for detection of Varicella-Zoster Virus (VZV) DNA in spectrum of clinical samples in individuals suspected or presenting with signs and symptoms of clinical VZV infection. Qualitative VZV PCR results can aid in diagnosis of cutaneous, subcutaneous, and visceral varicella.VZV is a member of the Herpesviridae family that causes two distinct clinical diseases in the infected individual. Varicella, or more commonly chickenpox, is the primary infection and is characterized by a generalized exanthematous rash. After primary infection, VZV characteristically becomes latent. Reactivation of the virus results in herpes zoster, or shingles, which is characterized by a vesicular rash limited to single dermatomes and is often associated with pain and paresthesia. Noncutaneous sites of VZV involvement after chickenpox or reactivation most frequently involve the central nervous system (CNS) and are manifested as acute cerebellar ataxia, encephalitis, meningitis, transverse myelitis, or Reye syndrome. Varicella pneumonitis is a serious complication of chickenpox that may be manifested as tachypnea, cough, dyspnea, and fever. VZV infection in immunocompromised individuals often leads to progressive disease state with involvement of multiple organs, including the lungs, liver, eyes, and central nervous system.This assay detects the VZV DNA in skin lesions, cerebro- spinal fluid (CSF), respiratory and eye specimens and whole blood. Detection of VZV DNA in CSF usually indicates active, not latent, infection. Detection of VZV DNA in appropriate clinical specimens permits rapid and sensitive patient testing.

Sexual Health & STDs

This test is used in the diagnosis of human herpesvirus 7 infection. HHV-7 is closely related to HHV-6 and CMV and can reactivate in transplant patients or other immune-compromised individuals. PCR may detect infection earlier than immunological methods and provides more rapid results than culture, but does not provide information on past exposure or immunity. Quantitative measurement may provide information on disease regression. Reportable range is 500 to 10,000,000 copies/mL (2.70 to 7.00 Log copies/mL).

Sexual Health & STDs

Human herpesvirus-8 (HHV-8) is associated with the development of all forms of Kaposi's sarcoma, as well as some other rare lymphoproliferative diseases, such as primary effusion lymphoma and multicentric castleman's disease. Quantitative PCR may be used to monitor the level of viremia in a patient, often in the context of therapy.

Sexual Health & STDs

This test is used in the diagnosis of human herpesvirus 7 infection. HHV-7 is closely related to HHV-6 and CMV and can reactivate in transplant patients or other immune-compromised individuals. PCR may detect infection earlier than immunological methods and provides more rapid results than culture, but does not provide information on past exposure or immunity. Quantitative measurement may provide information on disease regression. Reportable range is 500 to 10,000,000 copies/mL (2.70 to 7.00 Log copies/mL).

Sexual Health & STDs

Human herpesvirus-8 (HHV-8) is associated with the development of all forms of Kaposi's sarcoma, as well as with some other rare lymphoproliferative diseases, such as primary effusion lymphoma and multicentric Castleman's disease. Quantitative PCR may be used to monitor the level of viremia in a patient, often in the context of therapy. Reportable range is 1,000 to 10,000,000 copies/mL (3.00 to 7.00 Log copies/mL).

Sexual Health & STDs

This test is used to determine the presence of HHV-6 DNA in patients' specimens. Organisms may be detected by PCR prior to detection by immunological methods. PCR provides more rapid results than other methods, including culture. Reportable range is 500 to 2,000,000 copies/mL (2.70 to 6.30 log copies/mL).

Sexual Health & STDs

This test is used to determine the presence of HHV-6 DNA in patients' specimens. Organisms may be detected by PCR prior to detection by immunological methods. PCR provides more rapid results than other methods, including culture. Reportable range is 500 to 2,000,000 copies/mL (2.70 to 6.30 Log copies/mL).

Sexual Health & STDs

Varicella-Zoster Virus (VZV) is a member of the herpes virus group that causes varicella (chicken pox) and zoster (shingles). Varicella is the primary infection while zoster is caused by reactivation of the latent virus. HSV and VZV infection may be difficult to distinguish clinically. VZV can be recovered from vesicle fluid usually during the first three days of rash. The incubation period of VZV is 14-15 days and clinical signs of varicella include fever and malaise followed by a rash rapidly progressing to macules to papules to vesicles to crusts over the trunk, neck, face, arms and legs. Zoster is characterized by an inflammatory reaction of the posterior nerve root and ganglia accompanied by crops of vesicles over the skin.

Sexual Health & STDs

Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from mild to fatal. Herpes Simplex Virus Type 1 infection are usually found above the waist. Herpes Simplex Virus Type 2 infections are more commonly seen in association with the genitalia, and surrounding areas, and are usually sexually transmitted. It is important to note however, that both Herpes Simplex types 1 and 2 have been involved in all disease manifestations and locations of the body, following introduction of the virus through broken skin or mucous membranes.

Sexual Health & STDs

This test is intended for the qualitative detection of antibodies against Hepatitis E virus (HEV). HEV causes acute viral hepatitis and liver injury worldwide, although it is not commonly acquired in the United States. Diagnosis of acute infection can be achieved through the detection of IgM, whereas IgG may represent remote or past exposure. This test does not detect antibodies against other hepatitis-causing viruses, including Hepatitis A, B, or C.HEV is transmitted via the fecal-oral route, most commonly by consumption of contaminated water or undercooked meat. Signs and symptoms of HEV are similar to other causes of acute viral hepatitis and may include fever, fatigue, nausea, vomiting, jaundice, and dark urine. The disease can be mild and self-limiting, and most individuals recover from illness. Immunocompromised individuals, those with underlying liver conditions, and pregnant women are at increased risk for severe disease, including fulminant hepatitis. Testing is recommended in patients with viral hepatitis symptoms who have traveled to an endemic or outbreak area and/or have tested negative for other etiologies (Hepatitis A, Hepatitis B, Hepatitis C, other hepatotropic viruses, and causes of acute liver injury).Antibodies against HEV can typically be detected within 3-4 weeks after exposure. Anti-IgM declines during early convalescence and may be negative a few months post-exposure while anti-IgG can persist for years. Results should be correlated with patient risk factors and signs and symptoms consistent with Hepatitis E. False positive results can occur in low prevalence populations. False negative results can occur early during infection. If there is a high clinical suspicion for HEV, repeat testing can be performed in 2-4 weeks.References1. Q&As for Health Professionals, Viral Hepatitis, Centers for Disease Control and Prevention.www.cdc.gov/hepatitis/hev/hevfaq.htmPage last reviewed: September 15, 2020.2. Hepatitis E, World Health Organization.www.who.int/news-room/fact-sheets/detail/hepatitis-eLast updated: 20 July 20233. Aggarwal, R. et al. Diagnosis of hepatitis E. Nat Rev Gastroenterol Hepatol. 2013 Jan;10(1):24-33.4. American Academy of Pediatrics, Red Book 2018-2021. Report of the Committee of Infectious Diseases, 31st Edition

Sexual Health & STDs

Offered as part of multiple lab tests

Sexual Health & STDs

DNA testing is analytically more sensitive than culture, especially in patients with encephalitis or meningitis. DNA testing may be useful in diagnosis of infection in neonates. Neonates who have been exposed to HSV can develop disseminated infection and encephalitis. Encephalitis is usually due to HSV I whereas meningitis is usually due to HSV II. DNA testing provides reliable means to define the type.

Sexual Health & STDs

Offered as part of multiple lab tests

Sexual Health & STDs

Offered as part of multiple lab tests

Sexual Health & STDs

Useful in monitoring response to therapy and/or disease progression. Reportable range is 15 to 100,000,000 IU/mL (1.18-8.00 log IU/mL).

Sexual Health & STDs

Useful in monitoring therapy and/or disease progression. Reportable range is 15 to 100,000,000 IU/mL (1.18-8.00 log IU/mL)

Sexual Health & STDs

Offered as part of multiple lab tests

Sexual Health & STDs

Offered as part of multiple lab tests

Sexual Health & STDs

This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of patients with chronic HBV infection undergoing antiviral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment.The cobas® HBV Test is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to confirm the presence of HBV infection.Reportable range is 10 to 1,000,000,000 IU/mL (1.00 to 9.00 Log IU/mL).

Sexual Health & STDs, Infectious Diseases

Offered as part of multiple lab tests

Sexual Health & STDs

Offered as part of multiple lab tests

Sexual Health & STDs

Offered as part of multiple lab tests