Test Code LAB4202 SYPHILIS IgG ANTIBODY W/REFLEX TO RPR SCREEN
Specimen Type
Preferred Sample: Serum (SST, Gold, Corvac, Tiger, Red Top Tube)
Alternative Sample: EDTA Plasma (Lavender Top Tube)
Specimen Volume
1 mL
Minimum Volume
0.5 mL
Turnaround Time
3 Days
Test Schedule
Monday, Wednesday, Friday
Sample Stability
Serum: 5 days at 2-8°C; 1 year at -15 to -20oC Plasma: 2 days at 2-8oC
Method
CAPTIATM ELISA
Reference Ranges
Negative
Analyte | Non Reactive | Equivocal | Reactive |
SYPHILIS, IgG | <0.9 | >0.9 to <1.1 | > 1.1 |
Synonyms
syphilisT, Treponema pallidum
CPT Codes
86780
Specimen Rejection
Do not use lipemic, hemolyzed, or turbid specimens.
Interpretation
Treponemal Result CAPTIA™ Syphilis - IgG |
Non-Treponemal Result (NT) |
Report/interpretation for all except neonates or infants.2 |
Negative (nonreactive) Antibody Index ≤ 0.9 |
Nonreactive |
No serological evidence of infection with T. Pallidum (incubating or early primary syphilis cannot be excluded). |
Negative (nonreactive) Antibody Index ≤ 0.9 |
Reactive |
Current infection unlikely, probability of biological false positive secondary to other medical conditions (febrile diseases, immunizations, IV DU, autoimmune diseases, etc.). Recommend repeat testing (non-treponemal and treponemal by other test method). |
Positive (reactive) Antibody Index ≥ 1.1 |
Nonreactive |
Probably past infection or potential cross-reactivity with other spirochetes/related antigens; additional testing appropriate to clinical findings/history;1 possibility of false negative non-treponemal (NT) due to prozone and late syphilis or neurosyphilis. |
Positive (reactive) Antibody Index ≥ 1.1 |
Reactive |
Presumptive evidence of current infection (or inadequately treated infection, persistent infection, reinfection, or biological false positive if prior history); additional testing consistent with clinical assessment.1 |
Negative (nonreactive) Antibody Index ≤ 0.9 |
Not done |
Current or past infection unlikely; cannot exclude incubating or early syphilis. |
1 Quantitative non-treponemal testing; clinical history; repeated (sequential) serological testing for changes in titer. 2 HIV-infected individuals may have delayed seroreactivity or negative serology. |
Limitations
- Results from CAPTIA™ Syphilis-G should be considered in the context of all available clinical and laboratory data.
- A CAPTIA™ Syphilis-G non-reactive result does not preclude the possibility of:
(a) a very recent infection (within the last 2-3 weeks) with T.pallidum. (b) an old, successfully cured infection with T. pallidum (for example >10 years previous). - CAPTIA™ Syphilis-G may be reactive with sera from patients with Yaws (T. pallidum subspecies pertenue) or Pinta (T. carateum).
- 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.
- When performing clinical lab assays, any sera giving reactive or equivocal results must be supplemented with a quantitative non-treponemal test (such as RPR and VDRL) to distinguish active disease and assist in ruling out false positives. The CAPTIA™ Syphilis-G is a treponemal assay, therefore patients with previously treated syphilis will be positive on the assay.
- The use of CAPTIA™ Syphilis-G as an initial screening test for blood donors may result in higher numbers of reactive donors who may not be currently infected compared to screening donors with standard, non-treponemal assays. It is recommended that CAPTIA™ Syphilis-G repeat reactive specimens be tested by methods capable of indicating the current disease status of the donor e.g. RPR and VDRL tests.
- AIDS patients with impaired immunity and who are co-infected with syphilis may react falsely nonreactive in treponemal and non-treponemal tests.
- Reactive treponemal IgG antibody test results usually remain reactive for a lifetime; therefore, antibody indices cannot not be used to determine response to therapy.