Test Details
Methodology
See individual test components.
Result Turnaround Time
1 - 4 days
Use
Screen for and diagnose sexually transmitted infections and blood borne pathogens including syphilis, hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Testing aligns with current guidelines and recommendations.
Special Instructions
This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
If reflex test is performed, additional charges/CPT code(s) may apply.
HIV p24 Antigen/Antibody With Reflex to Confirmation [083935] requires a dedicated, unopened, gel-barrier tube or red-top tube sent directly to the testing facility.
Specimen Requirements
Test Includes
RPR with reflex to quantitative RPR and confirmatory Treponema pallidum antibodies; HIV p24 Antigen/Antibody with reflex to confirmation; HBV screening and diagnosis (HBsAg, anti-HBs, HBc-total with reflex to IgM); HCV antibody with reflex to quantitative real-time PCR; Chlamydia trachomatis NAA, Neisseria gonorrhoeae NAA, and Trichomonas vaginalis NAA. If reflex testing is performed, additional charges/CPT code(s) may apply.
Limitations
Some of the assays in this panel have not been FDA cleared or approved for the screening of blood or plasma donors, nor have assay performance characteristics been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age.
References
Specimen
Serum and swab or urine
Volume
Swab or 2 mL urine, 8 mL serum
Container
Aptima® (Gen-Probe®) Endocx/ureth swab or urine, gel-barrier tube
Storage Instructions
See individual test components.
Causes for Rejection
Hemolysis; lipemia; received outside of specimen and/or storage and/or labeling requirements; aliquot received for HIV testing; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; Aptima® urine transport >30 days from collection; Aptima® urine transport with incorrect specimen volume; Aptima® swab transport >60 days from collection; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; Aptima® transport device with multiple swabs
Collection Instructions
Serum specimen: Usual blood collection technique.
Ct/GC: Option 1: Gen-Probe® Aptima® endocervical or vaginal swab.
Endocervical swab: Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white-shaft swab in the package with red printing). Discard this swab. Insert the specimen collection swab (blue-shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents. Recap the swab specimen transport tube tightly.
Vaginal Swab:
Care Provider Specimen: Collect vaginal fluid sample using the Gen-Probe® Aptima® vaginal swab kit by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.
Patient Self-Collection: Partially open the package of the Gen-Probe® Aptima® vaginal swab kit. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima® swab specimen collection kit. Remove the swab. Carefully insert the swab into the vagina about two inches past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube, and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.
Ct/GC: Option 2: Urine Specimen: The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Female patients should not cleanse the labial area prior to providing the specimen. Add urine to the Aptima® Combo 2 urine collection device. The final volume must be between the two black lines on the device (about 2 mL).
Stability Requirements
Test Number | Sample Type | Room Temperature | Refrigerated | Frozen | Freeze/thaw Cycles |
---|---|---|---|---|---|
144473 | Serum or plasma | 14 days | 14 days | 14 days | Stable x3 |
144050 | Serum or plasma | Antibody test: 24 hours PCR test: 24 hours | Antibody test: 6 days PCR test: 72 hours | Antibody test: 14 days PCR test: 6 weeks | N/A N/A |
012005 | Serum | 14 days | 14 days | 14 days | Stable x3 |
083935 | Serum | 48 hours | 14 days | 14 days | Stable x5 |
183160 | Swab or urine | Aptima® swab: 60 days Aptima® urine: 30 days | Aptima® swab: 60 days Aptima® urine: 30 days | N/A | N/A |
LOINC® Map
Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
---|---|---|---|---|---|---|
144027 | STI Profile, CT/NG/TV | 006510 | HBsAg Screen | 5196-1 | ||
144027 | STI Profile, CT/NG/TV | 006408 | Hep B Surface Ab, Qual | 22322-2 | ||
144027 | STI Profile, CT/NG/TV | 006718 | Hep B Core Ab, Tot | 13952-7 | ||
144027 | STI Profile, CT/NG/TV | 006719 | Rfx to HBc IgM | 77202-0 | ||
144027 | STI Profile, CT/NG/TV | 006720 | Interpretation | 56850-1 | ||
144027 | STI Profile, CT/NG/TV | 144035 | HCV Ab | 40726-2 | ||
144027 | STI Profile, CT/NG/TV | 006072 | RPR | 20507-0 | ||
144027 | STI Profile, CT/NG/TV | 083936 | HIV Ab/p24 Ag Screen | 56888-1 | ||
144027 | STI Profile, CT/NG/TV | 183161 | Chlamydia by NAA | 43304-5 | ||
144027 | STI Profile, CT/NG/TV | 183162 | Gonococcus by NAA | 43305-2 | ||
144027 | STI Profile, CT/NG/TV | 188053 | Trich vag by NAA | 46154-1 | ||
144027 | STI Profile, CT/NG/TV | 019054 | 11502-2 | |||
Order Code | 144027 | |||||
Order Code Name | STI Profile, CT/NG/TV | |||||
Order Loinc | ||||||
Result Code | 006510 | |||||
Result Code Name | HBsAg Screen | |||||
UofM | ||||||
Result LOINC | 5196-1 | |||||
Order Code | 144027 | |||||
Order Code Name | STI Profile, CT/NG/TV | |||||
Order Loinc | ||||||
Result Code | 006408 | |||||
Result Code Name | Hep B Surface Ab, Qual | |||||
UofM | ||||||
Result LOINC | 22322-2 | |||||
Order Code | 144027 | |||||
Order Code Name | STI Profile, CT/NG/TV | |||||
Order Loinc | ||||||
Result Code | 006718 | |||||
Result Code Name | Hep B Core Ab, Tot | |||||
UofM | ||||||
Result LOINC | 13952-7 | |||||
Order Code | 144027 | |||||
Order Code Name | STI Profile, CT/NG/TV | |||||
Order Loinc | ||||||
Result Code | 006719 | |||||
Result Code Name | Rfx to HBc IgM | |||||
UofM | ||||||
Result LOINC | 77202-0 | |||||
Order Code | 144027 | |||||
Order Code Name | STI Profile, CT/NG/TV | |||||
Order Loinc | ||||||
Result Code | 006720 | |||||
Result Code Name | Interpretation | |||||
UofM | ||||||
Result LOINC | 56850-1 | |||||
Order Code | 144027 | |||||
Order Code Name | STI Profile, CT/NG/TV | |||||
Order Loinc | ||||||
Result Code | 144035 | |||||
Result Code Name | HCV Ab | |||||
UofM | ||||||
Result LOINC | 40726-2 | |||||
Order Code | 144027 | |||||
Order Code Name | STI Profile, CT/NG/TV | |||||
Order Loinc | ||||||
Result Code | 006072 | |||||
Result Code Name | RPR | |||||
UofM | ||||||
Result LOINC | 20507-0 | |||||
Order Code | 144027 | |||||
Order Code Name | STI Profile, CT/NG/TV | |||||
Order Loinc | ||||||
Result Code | 083936 | |||||
Result Code Name | HIV Ab/p24 Ag Screen | |||||
UofM | ||||||
Result LOINC | 56888-1 | |||||
Order Code | 144027 | |||||
Order Code Name | STI Profile, CT/NG/TV | |||||
Order Loinc | ||||||
Result Code | 183161 | |||||
Result Code Name | Chlamydia by NAA | |||||
UofM | ||||||
Result LOINC | 43304-5 | |||||
Order Code | 144027 | |||||
Order Code Name | STI Profile, CT/NG/TV | |||||
Order Loinc | ||||||
Result Code | 183162 | |||||
Result Code Name | Gonococcus by NAA | |||||
UofM | ||||||
Result LOINC | 43305-2 | |||||
Order Code | 144027 | |||||
Order Code Name | STI Profile, CT/NG/TV | |||||
Order Loinc | ||||||
Result Code | 188053 | |||||
Result Code Name | Trich vag by NAA | |||||
UofM | ||||||
Result LOINC | 46154-1 | |||||
Order Code | 144027 | |||||
Order Code Name | STI Profile, CT/NG/TV | |||||
Order Loinc | ||||||
Result Code | 019054 | |||||
Result Code Name | ||||||
UofM | ||||||
Result LOINC | 11502-2 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 016105 | HBsAg Confirmation | 016105 | HBsAg Confirmation | 7905-3 | |
Reflex 1 | ||||||
Order Code | 016105 | |||||
Order Name | HBsAg Confirmation | |||||
Result Code | 016105 | |||||
Result Name | HBsAg Confirmation | |||||
UofM | ||||||
Result LOINC | 7905-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 016881 | Hep B Core Ab, IgM | 016881 | Hep B Core Ab, IgM | 24113-3 | |
Reflex 1 | ||||||
Order Code | 016881 | |||||
Order Name | Hep B Core Ab, IgM | |||||
Result Code | 016881 | |||||
Result Name | Hep B Core Ab, IgM | |||||
UofM | ||||||
Result LOINC | 24113-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 144030 | Interpretation: | 144030 | Interpretation: | 13955-0 | |
Reflex 1 | ||||||
Order Code | 144030 | |||||
Order Name | Interpretation: | |||||
Result Code | 144030 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 13955-0 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 550362 | HCV RT-PCR, Quant (Non-Graph) | 550338 | Hepatitis C Quantitation | IU/mL | 11011-4 |
Reflex 1 | ||||||
Order Code | 550362 | |||||
Order Name | HCV RT-PCR, Quant (Non-Graph) | |||||
Result Code | 550338 | |||||
Result Name | Hepatitis C Quantitation | |||||
UofM | IU/mL | |||||
Result LOINC | 11011-4 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 550362 | HCV RT-PCR, Quant (Non-Graph) | 550338 | Hepatitis C Quantitation | IU/mL | 11011-4 |
Reflex 1 | ||||||
Order Code | 550362 | |||||
Order Name | HCV RT-PCR, Quant (Non-Graph) | |||||
Result Code | 550338 | |||||
Result Name | Hepatitis C Quantitation | |||||
UofM | IU/mL | |||||
Result LOINC | 11011-4 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 550362 | HCV RT-PCR, Quant (Non-Graph) | 550339 | HCV log10 | log10 IU/mL | 38180-6 |
Reflex 1 | ||||||
Order Code | 550362 | |||||
Order Name | HCV RT-PCR, Quant (Non-Graph) | |||||
Result Code | 550339 | |||||
Result Name | HCV log10 | |||||
UofM | log10 IU/mL | |||||
Result LOINC | 38180-6 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 550362 | HCV RT-PCR, Quant (Non-Graph) | 550314 | Test Information: | 19147-8 | |
Reflex 1 | ||||||
Order Code | 550362 | |||||
Order Name | HCV RT-PCR, Quant (Non-Graph) | |||||
Result Code | 550314 | |||||
Result Name | Test Information: | |||||
UofM | ||||||
Result LOINC | 19147-8 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 550362 | HCV RT-PCR, Quant (Non-Graph) | 550396 | Interpretation: | 62365-2 | |
Reflex 1 | ||||||
Order Code | 550362 | |||||
Order Name | HCV RT-PCR, Quant (Non-Graph) | |||||
Result Code | 550396 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 62365-2 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 006464 | RPR, Quant. | 006464 | RPR, Quant. | titer | 31147-2 |
Reflex 1 | ||||||
Order Code | 006464 | |||||
Order Name | RPR, Quant. | |||||
Result Code | 006464 | |||||
Result Name | RPR, Quant. | |||||
UofM | titer | |||||
Result LOINC | 31147-2 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 012021 | RPR Qn+TP Abs | 006464 | RPR, Quant. | titer | 31147-2 |
Reflex 1 | ||||||
Order Code | 012021 | |||||
Order Name | RPR Qn+TP Abs | |||||
Result Code | 006464 | |||||
Result Name | RPR, Quant. | |||||
UofM | titer | |||||
Result LOINC | 31147-2 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 012021 | RPR Qn+TP Abs | 082371 | Treponema pallidum Antibodies | 47236-5 | |
Reflex 1 | ||||||
Order Code | 012021 | |||||
Order Name | RPR Qn+TP Abs | |||||
Result Code | 082371 | |||||
Result Name | Treponema pallidum Antibodies | |||||
UofM | ||||||
Result LOINC | 47236-5 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 012021 | RPR Qn+TP Abs | 010002 | Interpretation: | 93479-4 | |
Reflex 1 | ||||||
Order Code | 012021 | |||||
Order Name | RPR Qn+TP Abs | |||||
Result Code | 010002 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 93479-4 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083941 | HIV 1 Ab | 68961-2 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083941 | |||||
Result Name | HIV 1 Ab | |||||
UofM | ||||||
Result LOINC | 68961-2 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083942 | HIV 2 Ab | 81641-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083942 | |||||
Result Name | HIV 2 Ab | |||||
UofM | ||||||
Result LOINC | 81641-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083954 | Interpretation: | 80203-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083954 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 80203-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083954 | Interpretation: | 80203-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083954 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 80203-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083954 | Interpretation: | 80203-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083954 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 80203-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083954 | Interpretation: | 80203-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083954 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 80203-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083954 | Interpretation: | 80203-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083954 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 80203-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083954 | Interpretation: | 80203-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083954 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 80203-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083954 | Interpretation: | 80203-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083954 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 80203-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083954 | Interpretation: | 80203-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083954 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 80203-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083954 | Interpretation: | 80203-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083954 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 80203-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083954 | Interpretation: | 80203-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083954 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 80203-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083954 | Interpretation: | 80203-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083954 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 80203-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 083940 | HIV 1/2 Ab Differentiation | 083954 | Interpretation: | 80203-3 | |
Reflex 1 | ||||||
Order Code | 083940 | |||||
Order Name | HIV 1/2 Ab Differentiation | |||||
Result Code | 083954 | |||||
Result Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | 80203-3 |