Early Detection of Perinatal Human Immunodeficiency Virus (HIV) Type 1 Infection Using HIV RNA Amplification and Detection

Steketee, Richard W.; Abrams, Elaine J.; Thea, Donald M.; Brown, Teresa M.; Lambert, Genevieve; Orloff, Sherry L.; Weedon, Jeremy; Bamji, Mahrukh; Schoenbaum, Ellie E.; Rapier, Jennifer; Kalish, Marcia L.

doi:10.1093/infdis/175.3.707

Cited by 114 publications

(35 citation statements)

References 11 publications

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“…65,67 HIV-1 RNA assays have been assessed to be at least as sensitive as, or more sensitive than, HIV-1 DNA assays among young infants. 52,59,[66][67][68]71 Similarly high specificity by 6 to 12 weeks of age (as compared with HIV-1 DNA assays or HIV-1 culture) has been observed among nonbreastfed infants. 52,59,65,68,72 HIV-1 RNA assays are now commonly used to diagnose HIV-1 infection in infants.…”

Section: Hiv-1 Naatsmentioning

confidence: 95%

“…These assays are available as "standard" or "ultrasensitive" assays, and the lower limit of detection possible when using the ultrasensitive assays is in the range of 50 to 75 HIV-1 copies per mL of plasma. Numerous studies of the use of HIV-1 RNA assays for the diagnosis of HIV-1 infection in pediatric populations have been conducted, 52,59,[65][66][67][68][69][70][71][72][73][74][75] with the reported sensitivity of testing (Table 3) for such assays ranging from 25% to 50% within the first few days of life to 100% by 6 to 12 weeks of age. 65,67 HIV-1 RNA assays have been assessed to be at least as sensitive as, or more sensitive than, HIV-1 DNA assays among young infants.…”

Section: Hiv-1 Naatsmentioning

confidence: 99%

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Diagnosis of HIV-1 Infection in Children Younger Than 18 Months in the United States

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2007

Pediatrics

118

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The objectives of this technical report are to describe methods of diagnosis of HIV-1 infection in children younger than 18 months in the United States and to review important issues that must be considered by clinicians who care for infants and young children born to HIV-1–infected women. Appropriate HIV-1 diagnostic testing for infants and children younger than 18 months differs from that for older children, adolescents, and adults because of passively transferred maternal HIV-1 antibodies, which may be detectable in the child's bloodstream until 18 months of age. Therefore, routine serologic testing of these infants and young children is generally only informative before the age of 18 months if the test result is negative. Virologic assays, including HIV-1 DNA or RNA assays, represent the gold standard for diagnostic testing of infants and children younger than 18 months. With such testing, the diagnosis of HIV-1 infection (as well as the presumptive exclusion of HIV-1 infection) can be established within the first several weeks of life among nonbreastfed infants. Important factors that must be considered when selecting HIV-1 diagnostic assays for pediatric patients and when choosing the timing of such assays include the age of the child, potential timing of infection of the child, whether the infection status of the child's mother is known or unknown, the antiretroviral exposure history of the mother and of the child, and characteristics of the virus. If the mother's HIV-1 serostatus is unknown, rapid HIV-1 antibody testing of the newborn infant to identify HIV-1 exposure is essential so that antiretroviral prophylaxis can be initiated within the first 12 hours of life if test results are positive. For HIV-1–exposed infants (identified by positive maternal test results or positive antibody results for the infant shortly after birth), it has been recommended that diagnostic testing with HIV-1 DNA or RNA assays be performed within the first 14 days of life, at 1 to 2 months of age, and at 3 to 6 months of age. If any of these test results are positive, repeat testing is recommended to confirm the diagnosis of HIV-1 infection. A diagnosis of HIV-1 infection can be made on the basis of 2 positive HIV-1 DNA or RNA assay results. In nonbreastfeeding children younger than 18 months with no positive HIV-1 virologic test results, presumptive exclusion of HIV-1 infection can be based on 2 negative virologic test results (1 obtained at ≥2 weeks and 1 obtained at ≥4 weeks of age); 1 negative virologic test result obtained at ≥8 weeks of age; or 1 negative HIV-1 antibody test result obtained at ≥6 months of age. Alternatively, presumptive exclusion of HIV-1 infection can be based on 1 positive HIV-1 virologic test with at least 2 subsequent negative virologic test results (at least 1 of which is performed at ≥8 weeks of age) or negative HIV-1 antibody test results (at least 1 of which is performed at ≥6 months of age). Definitive exclusion of HIV-1 infection is based on 2 negative virologic test results, 1 obtained at ≥1 month of age and 1 obtained at ≥4 months of age, or 2 negative HIV-1 antibody test results from separate specimens obtained at ≥6 months of age. For both presumptive and definitive exclusion of infection, the child should have no other laboratory (eg, no positive virologic test results) or clinical (eg, no AIDS-defining conditions) evidence of HIV-1 infection. Many clinicians confirm the absence of HIV-1 infection with a negative HIV-1 antibody assay result at 12 to 18 months of age. For breastfeeding infants, a similar testing algorithm can be followed, with timing of testing starting from the date of complete cessation of breastfeeding instead of the date of birth.

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Section: Hiv-1 Naatsmentioning

confidence: 95%

Section: Hiv-1 Naatsmentioning

confidence: 99%

Diagnosis of HIV-1 Infection in Children Younger Than 18 Months in the United States

Read¹

2007

Pediatrics

118

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“…The assay requires only an enzyme immunosorbent assay washer, a reader, a heat block, and an incubator, as opposed to the thermocycler required by nucleic acid technologies. We evaluated the sensitivity and specificity of this assay for early-infancy diagnosis of HIV infection using stored plasma specimens from HIV-exposed infants of 0 to 180 days of age from two U.S. cohorts: the North Carolina Children's AIDS Network cohort (9-11) (n ϭ 154) and the New York City Pediatric AIDS Collaborative Transmission Study (PACTS) cohort (1,4,13,28,29) (n ϭ 648). Selection criteria included sufficient volume to perform the testing.…”

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confidence: 99%

Ultrasensitive p24 Antigen Assay for Diagnosis of Perinatal Human Immunodeficiency Virus Type 1 Infection

et al. 2007

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“…The viral loads of HIV-infected infants may start out low at birth and increase over time (13). Therefore, a more sensitive HIV PCR test can lead to earlier, more accurate diagnosis (14), which can minimize the occurrence of We have demonstrated that the TaqMan HIV-1 Qual Test version v2.0 has increased sensitivity compared to the previously determined sensitivity for the v1.0 assay (15).…”

Section: Discussionmentioning

confidence: 82%

Improved Sensitivity of a Dual-Target HIV-1 Qualitative Test for Plasma and Dried Blood Spots

et al. 2016

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eThe use of nucleic acid detection for HIV type 1 (HIV-1) detection is strongly recommended in infants <18 months of age, in whom serology is unreliable. This study evaluated the Cobas AmpliPrep/Cobas TaqMan HIV-1 Qualitative Test v2.0 (TaqMan HIV-1 Qual Test, v2.0), a dual-target total nucleic acid real-time PCR assay. The limit of detection (LOD) of the new test in plasma and dried blood spots (DBS) was determined with the 2nd International HIV-1 RNA WHO standard. The specificity of the assay was tested with EDTA plasma (n ‫؍‬ 1,301) and DBS from HIV-negative adults (n ‫؍‬ 1,000). The sensitivity was determined using HIV-1-positive samples (n ‫؍‬ 169 adult EDTA plasma, n ‫؍‬ 172 adult DBS, and n ‫؍‬ 100 infant DBS) that included group M, subtypes A to H, CRF01_AE, CRF02_AG, and groups O and N. All positive specimens and a subset of the negative specimens were also tested with the Abbott RealTime HIV-1 Qual assay (RealTime). The LOD of the TaqMan assay was 20 copies/ml in plasma and 300 copies/ml in DBS, with specificities of 99.8% in plasma and 99.9% in DBS. The TaqMan . Although access to early infant diagnosis of HIV is improving, in 2011 only 35% of infants born to HIV-positive mothers were tested within 2 months of birth (1). The Joint United Nations Programme on HIV/AIDS (UNAIDS) call for action has set new targets for 2020, the first of which is for 90% of those infected with HIV to know their status. Improved assays like the one evaluated in this study should assist in increasing access to HIV diagnosis, particularly in a vulnerable pediatric population that requires nucleic acid-based testing (2). Transmission of HIV occurs through sexual contact, exposure to infected blood products (3), and vertical mother-to-child transmission (4). For many infected infants, the progression of AIDS is rapid, and thus, early antiretroviral therapy is crucial for survival. In a randomized, controlled clinical trial in South Africa, it was demonstrated that early HIV diagnosis and early antiretroviral therapy could reduce early infant mortality by 76% and slow HIV progression by 75% (5). Access to HIV testing and early confirmation of a pediatric infection are thus critical for immediate access to treatment and care programs. Nucleic acid testing is particularly important for early diagnosis of infants Յ18 months of age. In this population, serologic tests are unreliable for the identification of true virologic status, because passively transferred maternal HIV type 1 (HIV-1) antibodies may be detectable in the HIV-exposed infant for up to 18 months of life (6) or longer in some instances (7). Thus, the World Health Organization (WHO) strongly recommends that HIV virological testing be used to diagnose HIV infections in infants and children below 18 months of age (8). The regions that are most severely affected by the HIV epidemic, such as sub-Saharan Africa, are often faced with severe resource constraints limiting access to virological testing. The difficulties of cold-chain transfer of collected blood samples from ...

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Early Detection of Perinatal Human Immunodeficiency Virus (HIV) Type 1 Infection Using HIV RNA Amplification and Detection

Cited by 114 publications

References 11 publications

Diagnosis of HIV-1 Infection in Children Younger Than 18 Months in the United States

Diagnosis of HIV-1 Infection in Children Younger Than 18 Months in the United States

Ultrasensitive p24 Antigen Assay for Diagnosis of Perinatal Human Immunodeficiency Virus Type 1 Infection

Improved Sensitivity of a Dual-Target HIV-1 Qualitative Test for Plasma and Dried Blood Spots

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