Test Details
Methodology
Electrochemiluminescience immunoassay (ECLIA)
Result Turnaround Time
1 - 3 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This test is used for qualitative detection of IgG antibodies specific to HSV type 2. This test is intended for sexually active individuals and pregnant individuals as an aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lesions or associated disease manifestations, particularly in primary infection. The predictive value of positive an negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The detection of HSV-2 IgG antibodies in a single sample indicates a previous exposure to HSV-2 but does not give information as to the site of HSV infection or the timing of exposure.
Limitations
A negative test result does not completely rule out the possibility of an infection with HSV 2. Individuals may not exhibit any detectable IgG antibodies at the early state of acute infection. False negative results may occur when the HSV virus is glycoprotein G (gG) deficient (0.2% HSV isolates were gG deficient). False-positive results may occur. Repeat testing, or testing by a different method, may be indicated in some settings (e.g., patients with low likelihood of HSV-2 infection). The results in HIV patients, in patients undergoing immunosuppressive therapy, or in patients with other disorders leading to immune suppression, should be interpreted with caution. Specimens from neonates, cord blood, pretransplant patients or body fluids other than serum and plasma, such as urine, saliva or amniotic fluid, have not been tested. The results should be assessed in conjunction with the patient's medical history, clinical examination and other findings.
Specimen Requirements
Specimen
Serum
Volume
1.0 mL
Minimum Volume
0.4 mL (Note: This volume does not allow for repeat testing.)
Container
Red-top tube, gel-barrier tube or serum transfer tube
Collection Instructions
If tube other than a gel-barrier is used, transfer separated serum to a plastic transport tube.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 2 days |
| Refrigerated | 7 days |
| Frozen | 12 weeks |
| Freeze/thaw cycles | Stable x5 |
Storage Instructions
Refrigerate.
Causes for Rejection
Gross hemolysis; obvious microbial contamination and/or received outside of specimen and/or storage and/or requirements; heat-inactivated samples
References
Miller JM, Binnicker MJ, Campbell S, et al. Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2024 Update by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM). Clin Infect Dis. 2024 Mar 5:ciae104. PubMed 38442248
Workowski KA, Bachmann LH, Chan PH, et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recom Rep. 2021 Jul 23;70(4):1-187. PubMed 34292926
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 164098 | HSV-2 Ab, IgG | 5209-2 | 164097 | HSV 2 IgG, Type Spec | 43180-9 | |
| Order Code | 164098 | |||||
| Order Code Name | HSV-2 Ab, IgG | |||||
| Order Loinc | 5209-2 | |||||
| Result Code | 164097 | |||||
| Result Code Name | HSV 2 IgG, Type Spec | |||||
| UofM | ||||||
| Result LOINC | 43180-9 |