STD - Comprehensive

The STD - Comprehensive panel contains 4 tests with 12 biomarkers.

The STD - Comprehensive panel contains the following tests:

  • Chlamydia/Neisseria gonorrhoeae RNA, TMA
  • RPR (Monitor) with Reflex to Titer
  • Herpes Simplex Virus 1/2 (IgG), Type-Specific Antibodies (HerpeSelect®)
  • Hepatitis Panel, General

Due to the consultation and reporting requirements, we are unable to offer HIV testing at this time.

Chlamydia/Neisseria gonorrhoeae RNA, TMA

Patient Preparation 

Urine specimen: The patient should not have urinated for at least one hour prior to specimen collection. Female patients should not cleanse the labial area prior to providing the specimen.

Urine: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen. Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the APTIMA® specimen transport within 24 hours of collection and before being assayed. Use tube provided in the urine specimen collection kit for urine specimens. The fluid (urine plus transport media) level in the urine tube must fall within the clear pane on the tube label.

 

Clinical Significance

C. trachomatis infections are the leading cause of sexually transmitted diseases in the United States. C. trachomatis is 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 of Chlamydialinfections are severe if left untreated. Approximately half of Chlamydial infections 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.

Herpes Simplex Virus 1/2 (IgG), Type-Specific Antibodies (HerpeSelect®) 

HSV 1 IGG, TYPE SPECIFIC AB

HSV 2 IGG, TYPE SPECIFIC AB

Diagnose HSV infection when lesions are absent; determine HSV type

Reference Range(s)

Index Interpretation

<0.90 Negative

0.90-1.09 Equivocal

>1.09 Positive

This assay utilizes recombinant type-specific antigens to differentiate HSV-1 from HSV-2 infections. A index positive result cannot distinguish between recent and past infection. If recent HSV infection is suspected but the results are negative or equivocal, the assay should be repeated in 4-6 weeks. The performance index characteristics of the assay have not been established for pediatric populations, immunocompromised patients, or neonatal screening.

Limitations

Individuals infected with HSV may not exhibit detectable IgG antibody in the early stages of infection.

Clinical Significance

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.

 

Syphilis RPR ( RPR (Monitor) with Reflex to Titer)

Reference Range(s)

Non-Reactive

Clinical Significance

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.

IMPORTANT

A positive RPR screen must be followed by a specific treponemal antibody test (e.g., FTA-ABS):

A positive result on the second method confirms the screening result and the affected person is diagnosed with syphilis.

A negative result on the treponemal test may mean that the initial RPR test was falsely positive. Further testing and investigation may be done to determine the cause of the false positive.

Limitations

False-positive results have been associated in patients with infections, pregnancy, autoimmune disease, old age, Gaucher disease, and malignancy.

Hepatitis Panel, General

Hepatitis A Antibody, Total; Hepatitis B Surface Antibody, Qualitative; Hepatitis B Surface Antigen with Reflex Confirmation; Hepatitis B Core Antibody, Total; Hepatitis C Antibody with Reflex to HCV, RNA, Quantitative, Real-Time PCR

Hepatitis B Surface Antigen with Reflex Confirmation: Positive samples will be confirmed based on the manufacturer's FDA approved recommendations at an additional charge (CPT code(s): 87341).


If Hepatitis C Antibody is reactive, Hepatitis C Viral RNA, Quantitative, Real-Time PCR will be performed at an additional charge (CPT code(s): 87522).

The following is a list of what is included in the item above. Click the test(s) below to view what biomarkers are measured along with an explanation of what the biomarker is measuring.

Also known as: ChlamydiaNeisseria gonorrhoeae RNA TMA, CT/GC APTIMA®, CT/GC TMA, CT/NG APTIMA®, CT/NG TMA, Hologic

Chlamydia Trachomatis

This test is looking for evidence of infection by the bacterium Chlamydia trachomatis. Chlamydia is the most common bacterial sexually transmitted disease (STD) in the United States. About 75% of infected women and 50% of infected men have no symptoms; some may experience only mild symptoms. For women, symptoms, if they occur, include bleeding between menstrual periods and after sexual intercourse, abdominal pain, painful intercourse, and an abnormal vaginal discharge. For men, symptoms include pus or milky discharge from the penis and inflammation of the prostate (prostatitis) or of the rectal area (proctitis). Both sexes can experience painful or frequent urination.

Neisseria Gonorrhoeae

The test is looking for presence of the bacterium Neisseria gonorrhoeae, which causes the sexually transmitted disease gonorrhea. The Centers for Disease Control and Prevention (CDC) estimates that more than 700,000 people in the U.S. get new gonorrheal infections each year. While many men with gonorrhea will experience symptoms, most women do not, or will mistake gonorrhea symptoms for a bladder or other vaginal infection. For men, symptoms usually appear within 2 to 5 days of infection but can take up to 30 days. Women who experience symptoms usually do so within 10 days of infection.

Also known as: Hepatitis Panel General

Confirmation

Hepatitis A Ab, Total

Hepatitis B Core Ab Total

Hepatitis B Surface

Hepatitis B Surface

Hepatitis C Antibody

The Hepatitis C Antibody Test, sometimes called the Anti-HCV Test, looks for antibodies to the Hepatitis C virus. Antibodies are chemicals released into the bloodstream when someone gets infected.

Signal To Cut-Off

Also known as: Herpes Simplex Virus 12 IgG TypeSpecific Antibodies HerpeSelect

Hsv 1 IgG Type Specific

Herpes simplex virus testing is performed to identify an acute herpes infection or to detect herpes antibodies, an indication of a previous exposure to herpes. One of the most common viral infections, herpes simplex virus (HSV) exists as two main types, HSV-1 and HSV-2. Both types are contagious and periodically cause small fever blisters (vesicles) that break to form open lesions. HSV-1 primarily causes blisters or "cold sores" around the oral cavity and mouth, while HSV-2 usually causes lesions around the genital area; however, either one can affect the oral or genital area.

Hsv 2 IgG Type Specific

Herpes simplex virus testing is performed to identify an acute herpes infection or to detect herpes antibodies, an indication of a previous exposure to herpes. One of the most common viral infections, herpes simplex virus (HSV) exists as two main types, HSV-1 and HSV-2. Both types are contagious and periodically cause small fever blisters (vesicles) that break to form open lesions. HSV-1 primarily causes blisters or "cold sores" around the oral cavity and mouth, while HSV-2 usually causes lesions around the genital area; however, either one can affect the oral or genital area.

Also known as: RPR Monitor with Reflex to Titer, Syphilis

Rpr (Monitor)

RPR (rapid plasma reagin) is a screening test for syphilis. It looks for antibodies that are present in the blood of people who have the disease.
*Process times are an estimate and are not guaranteed. The lab may need additional time due to weather, holidays, confirmation/repeat testing, or equipment maintenance.