HIV-1 RNA, Qualitative TMA; HIV Ag/Ab, 4th Generation with reflexes
HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes:
HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes - This test is used to help diagnose HIV-1 and HIV-2 infection, including acute infection, and to differentiate HIV-1 from HIV-2. It is consistent with the HIV diagnostic algorithm proposed by the Centers for Disease Control and Prevention [2]. It can be used in adults, including pregnant women, and in children at least 2 years old.
This test allows detection of acute HIV-1 infection based on the presence of p24 antigen, before seroconversion occurs, allowing for earlier diagnosis than with previous tests. It can also detect HIV-1 and HIV-2 post-seroconversion, based on antibodies. If the HIV-1/HIV-2 antigen/antibody test is positive, an antibody-based HIV-1/HIV-2 test is done (at additional charge) to confirm infection and identify whether it is caused by HIV-1 or HIV-2. However, the HIV-1/HIV-2 differentiation test will be negative during acute infection (prior to development of specific antibodies). If the antibody-based HIV-1/HIV-2 test is negative, the blood specimen will be reflex-tested for the presence of HIV-1 RNA (at additional charge) to identify patients with acute HIV-1 infection [1].
The United States Preventive Services Task Force (USPSTF) recommends HIV screening for all pregnant women, and for individuals between 15 and 65 years of age who live in regions with an HIV prevalence of >0.1% [2]. In addition, antigen/antibody-based HIV testing is recommended for high-risk individuals who want to begin pre-exposure prophylaxis (PrEP) therapy, because HIV-positive patients who start PrEP without knowing their HIV status face an elevated risk of antiretroviral resistance [3,4].
Because 40% of new HIV infections are transmitted unknowingly by people unaware of their HIV status, early diagnosis is important to reduce HIV transmission [5]. Antigen/antibody-based HIV screening assays have >99.7% sensitivity and >99.3% specificity for HIV infection and can identify most (>80%) acute infections that would otherwise require nucleic acid testing for detection [6,7].
HIV-1 RNA, Qualitative, Real-Time PCR:
HIV-1 RNA, Qualitative, Real-Time PCR - HIV-1 Qualitative is an in vitro nucleic acid amplification test for the qualitative detection of human immunodeficiency virus type 1 (HIV-1) RNA in human serum and plasma by PCR. The test is intended to be used as an aid in diagnosis of HIV-1 infection. Detection of HIV-1 nucleic acid is indicative of HIV-1 infection. The presence of HIV-1 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 is indicative of acute or primary HIV-1 infection. The HIV-1 Qualitative PCR may also be used as an additional test to confirm the presence of HIV-1 infection in an individual with specimens reactive for HIV-1 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 in pediatric subjects and pregnant women. This assay is not intended to be used for monitoring patient status, or for screening donors of blood, plasma, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for HIV.
* This volume does not allow for repeat testing
Centrifuge and separate serum from cells within 24 hours after collection
Whole Blood
Frozen serum in Serum separator tube (SST) in situ
Transport
* This volume does not allow for repeat testing
Centrifuge and separate serum from cells within 24 hours after collection
Whole Blood
Transport
HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes: Negative
HIV-1 RNA, Qualitative, Real-Time PCR: Not Detected
Antibody Differentiation assay is Indeterminate or Negative, HIV-1 RNA, Qualitative, TMA will be ordered and charged
HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes:
HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes - This test is used to help diagnose HIV-1 and HIV-2 infection, including acute infection, and to differentiate HIV-1 from HIV-2. It is consistent with the HIV diagnostic algorithm proposed by the Centers for Disease Control and Prevention [2]. It can be used in adults, including pregnant women, and in children at least 2 years old.
This test allows detection of acute HIV-1 infection based on the presence of p24 antigen, before seroconversion occurs, allowing for earlier diagnosis than with previous tests. It can also detect HIV-1 and HIV-2 post-seroconversion, based on antibodies. If the HIV-1/HIV-2 antigen/antibody test is positive, an antibody-based HIV-1/HIV-2 test is done (at additional charge) to confirm infection and identify whether it is caused by HIV-1 or HIV-2. However, the HIV-1/HIV-2 differentiation test will be negative during acute infection (prior to development of specific antibodies). If the antibody-based HIV-1/HIV-2 test is negative, the blood specimen will be reflex-tested for the presence of HIV-1 RNA (at additional charge) to identify patients with acute HIV-1 infection [1].
The United States Preventive Services Task Force (USPSTF) recommends HIV screening for all pregnant women, and for individuals between 15 and 65 years of age who live in regions with an HIV prevalence of >0.1% [2]. In addition, antigen/antibody-based HIV testing is recommended for high-risk individuals who want to begin pre-exposure prophylaxis (PrEP) therapy, because HIV-positive patients who start PrEP without knowing their HIV status face an elevated risk of antiretroviral resistance [3,4].
Because 40% of new HIV infections are transmitted unknowingly by people unaware of their HIV status, early diagnosis is important to reduce HIV transmission [5]. Antigen/antibody-based HIV screening assays have >99.7% sensitivity and >99.3% specificity for HIV infection and can identify most (>80%) acute infections that would otherwise require nucleic acid testing for detection [6,7].
HIV-1 RNA, Qualitative, Real-Time PCR:
HIV-1 RNA, Qualitative, Real-Time PCR - HIV-1 Qualitative is an in vitro nucleic acid amplification test for the qualitative detection of human immunodeficiency virus type 1 (HIV-1) RNA in human serum and plasma by PCR. The test is intended to be used as an aid in diagnosis of HIV-1 infection. Detection of HIV-1 nucleic acid is indicative of HIV-1 infection. The presence of HIV-1 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 is indicative of acute or primary HIV-1 infection. The HIV-1 Qualitative PCR may also be used as an additional test to confirm the presence of HIV-1 infection in an individual with specimens reactive for HIV-1 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 in pediatric subjects and pregnant women. This assay is not intended to be used for monitoring patient status, or for screening donors of blood, plasma, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for HIV.
1. Moyer V, USPTF. Ann Intern Med. 2013;159:51-60.
2. CDC. New CDC recommendations for HIV testing in laboratories. https://www.cdc.gov/nchhstp/newsroom/docs/2014/hiv-testing-labs-flowchart.pdf. Published June 2014. Accessed May 20, 2019.
3. CDC. PrEP. https://www.cdc.gov/hiv/basics/prep.html. Published February 2019. Accessed May 20, 2019.
4. Livant E, et al. J Clin Virol. 2017;94:15-21.
5. CDC. HIV testing. https://www.cdc.gov/hiv/testing/index.html. Published March 2019. Accessed May 20, 2019.
6. Nasrullah M, et al. AIDS. 2013;27:731-737.
7. Chavez P, et al. J Clin Virol. 2011;52(Suppl 1):S51-S55.
1 to 5 days
86701 (Reflexes 87535), 86702; 87535 If HIV Antigen and Antibody, 4th Generation Screen is Repeatedly Reactive, then HIV-1/2 Antibody Differentiation will be performed at an additional charge (CPT code(s): 86701, 86702). If HIV-1/2 Antibody Differentiation is Indeterminate or Negative, then HIV-1 RNA, Qualitative Real-Time PCR will be performed at an additional charge (CPT code(s): 87535).