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Print CPT 81001; 85025; 86592; 86762; 86803; 86850; 86900; 86901; 87086; 87340; 87389; 87491; 87591
Synonyms
- Obstetric
- Pregnancy
- Prenatal
- Women's Health
Test Details
Turnaround Time
1 - 4 days
Use
Initial screening profile intended for the first prenatal visit to evaluate health status in early pregnancy. This profile aligns with current clinical guidelines and recommendations (see references).
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.
Test Includes
CBC with platelet count and differential; ABO grouping and Rh typing; antibody screen (includes ID and titer of all irregular antibodies detected); urinalysis, complete with microscopic examination; urine culture, comprehensive; HBsAg screen; rubella antibodies, IgG; syphilis serology (if RPR positive, Treponema pallidum-specific test is performed); HIV p24 antigen/antibody screen with reflex; HCV antibody with reflex to quantitative real-time PCR; Chlamydia trachomatis and Neisseria gonorrhoeae NAAT
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
Specimen Requirements
Information on collection, storage, and volume
Specimen
Serum and whole blood and urine (UA/Culture) and endocervical swab, vaginal swab, or first-void urine (patient should not have urinated for one hour prior to specimen collection)
Volume
9 mL serum, 8 mL whole blood to fill line on Vacutainer® gray top, 10 mL (red/yellow), one swab (endocervical, vaginal, or urethral), 2 mL of a 20 mL to 30 mL urine collection
Container
Gel-barrier tube and lavender-top (EDTA) tube and gray-top Vacutainer® for urine culture and urinalysis transport (red/yellow) and Gen-Probe® Aptima® swab or Aptima® urine specimen transport
Storage Instructions
See individual test components.
Causes for Rejection
Grossly hemolyzed and/or contaminated serum and/or plasma specimens; specimen types other than those listed above; specimens received in containers other than those specified above; specimens received outside of the stated stability requirements; specimens without correct labeling
Collection
Serum specimen: Usual blood collection technique.
Urine (urinalysis and culture): A voided specimen is usually suitable. If the specimen is likely to be contaminated, a clean catch midstream specimen is desirable.
Lavender-top (EDTA): Gently invert lavender top tubes 8-10 times immediately to mix specimen with anticoagulant.
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).