Sexually Transmitted Infections (STI) Profile, With CT/NG NAA

CPT: 86592; 86704; 86706; 86803; 87340; 87389; 87491; 87591
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Synonyms

  • Chlamydia
  • Gonorrhea
  • HBV
  • HCV
  • Hepatitis
  • HIV
  • Syphilis

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 and Neisseria gonorrhoeae NAA. If reflex testing is performed, additional charges/CPT code(s) may apply.


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.

Note: Client must clearly label the site/source of each Chlamydia/Gonococcus Nucleic Acid Amplification specimen.

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.


Expected Turnaround Time

1 - 4 days


Related Documents


Specimen Requirements


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


Collection

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).


Storage Instructions

See individual test components.


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

183194

Swab or urine

Aptima® swab: 60 days

Aptima® urine: 30 days

Aptima® swab: 60 days

Aptima® urine: 30 days

N/A

N/A


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


Test Details


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, and Neisseria gonorrhoeae. Testing aligns with current guidelines and recommendations.


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.


Methodology

See individual test components.


References

AAP Committee on Fetus and Newborn and ACOG Committee on Obstetric Practice. Guidelines for Perinatal Care. Kilpatrick SJ, Papile LA, Macones GA, eds. 8th edition, September 2017.
Centers for Disease Control and Prevention (CDC). Hepatitis B. CDC website: www.cdc.gov/hepatitis/hbv/index.htm. Accessed March 2022.
Centers for Disease Control and Prevention (CDC), The American College of Obstetrics and Gynecologists. Screening and Referral Algorithm for Hepatitis B Virus (HBV) Infection Among Pregnant Women. CDC website: https://www.cdc.gov/hepatitis/hbv/pdfs/prenatalhbsagtesting_508.pdf. Accessed March 2022.
Schillie S, Vellozzi C, Reingold A, et al. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018; 67(1):1-31.29939980
U.S. Department of Health and Human Service. 2020. Sexually Transmitted Infections: National Strategic Plan for the United States 2021-2025. Washington, DC. Accessed March 2022 at https://www.hhs.gov/sites/default/files/STI-National-Strategic-Plan-2021-2025.pdf.
U.S. Preventive Services Task Force: Screening for Hepatitis B Virus Infection in Pregnant Women: Recommendation Statement. Am Fam Physician. 2020 Jan 15;101(2):112-114.31939639

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
144082 STI Profile, CT/NG 006510 HBsAg Screen 5196-1
144082 STI Profile, CT/NG 006408 Hep B Surface Ab, Qual 22322-2
144082 STI Profile, CT/NG 006718 Hep B Core Ab, Tot 13952-7
144082 STI Profile, CT/NG 006719 Rfx to HBc IgM 77202-0
144082 STI Profile, CT/NG 006720 Interpretation 56850-1
144082 STI Profile, CT/NG 144035 HCV Ab 40726-2
144082 STI Profile, CT/NG 006072 RPR 20507-0
144082 STI Profile, CT/NG 083936 HIV Ab/p24 Ag Screen 56888-1
144082 STI Profile, CT/NG 188078 Chlamydia trachomatis, NAA 43304-5
144082 STI Profile, CT/NG 188086 Neisseria gonorrhoeae, NAA 43305-2
144082 STI Profile, CT/NG 019054 PDF N/A
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 016105 HBsAg Confirmation 016105 HBsAg Confirmation 7905-3
Reflex Table for Rfx to HBc IgM
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 Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 144030 Interpretation: 144030 Interpretation: 13955-0
Reflex Table for HCV Ab
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 2 550352 HCV RNA (International Units) 550353 HCV RNA (International Units) IU/mL 11011-4
Reflex Table for HCV Ab
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 2 550352 HCV RNA (International Units) 550354 HCV log10 log10 IU/mL 38180-6
Reflex Table for HCV Ab
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 Table for HCV Ab
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 Table for HCV Ab
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 Table for RPR
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 006464 RPR, Quant. 006464 RPR, Quant. titer 31147-2
Reflex Table for RPR
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 Table for RPR
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 Table for HIV Ab/p24 Ag Screen
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 Table for HIV Ab/p24 Ag Screen
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 Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083964 HIV-1/HIV-2 Qualitative RNA 139826 HIV-1 RNA 25835-0
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083964 HIV-1/HIV-2 Qualitative RNA 139827 HIV-2 RNA 69353-1
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083964 HIV-1/HIV-2 Qualitative RNA 083965 Final Interpretation 85380-4
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083964 HIV-1/HIV-2 Qualitative RNA 083944 HIV 1/2 Supplemental Ab Test N/A
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083962 HIV-1/HIV-2 Qualitative RNA 139826 HIV-1 RNA 25835-0
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083962 HIV-1/HIV-2 Qualitative RNA 139827 HIV-2 RNA 69353-1
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083962 HIV-1/HIV-2 Qualitative RNA 083963 Final Interpretation 85380-4
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083962 HIV-1/HIV-2 Qualitative RNA 083944 HIV 1/2 Supplemental Ab Test N/A
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083966 HIV-1/HIV-2 Qualitative RNA 139826 HIV-1 RNA 25835-0
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083966 HIV-1/HIV-2 Qualitative RNA 139827 HIV-2 RNA 69353-1
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083966 HIV-1/HIV-2 Qualitative RNA 083967 Final Interpretation 85380-4
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083966 HIV-1/HIV-2 Qualitative RNA 083944 HIV 1/2 Supplemental Ab Test N/A

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