Prospective Evaluation of Amplification‐Boosted ELISA for Heat‐Denatured p24 Antigen for Diagnosis and Monitoring of Pediatric Human Immunodeficiency Virus Type 1 Infection

Nadal, David; Böni, Jürg; Kind, Christian; Varnier, Oliviero E.; Steiner, Felicitas; Tomasik, Zuzana; Schüpbach, Jörg

doi:10.1086/315012

Cited by 74 publications

(54 citation statements)

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“…Similar results have been observed with subtype B in Switzerland (87% sensitivity and 99% specificity [n ϭ 873]) (19), subtype E in Thailand (100% sensitivity and 100% specificity in 142 samples) (30), subtype C in South Africa (n, 203 [27] and 141 [21]) and Zimbabwe (n ϭ 164 [34] [97 to 98% sensitivity and 97 to 99% specificity]), and multiple subtypes from the Democratic Republic of Congo with either plasma (n ϭ 150) (sensitivity, 92.3%; specificity, 100%) or dried plasma spots (n ϭ 87) (sensitivity and specificity, 100%) (6). Our data con- There has been some concern about the specificity of the Up24 assay with very young (less than 1 month old) infants, as the p24 antigen might cross the placenta and be detected (24).…”

supporting

confidence: 86%

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

et al. 2007

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supporting

confidence: 86%

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

et al. 2007

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“…Many studies of p24 antigen for diagnosis of HIV-1 infection have been conducted over the past several years, 49,[76][77][78][79][80][81][82][83][84][85][86][87][88][89][90][91][92][93] with the sensitivity of the assay increasing with increasingly effective techniques used to dissociate p24 antigen from anti-p24 antibody (immune complex-dissociated p24 antigen detection). 94 In general, p24 antigen assays have been used much less frequently than HIV-1 DNA-or RNA-amplification techniques for diagnosis of HIV-1 infection because of the relatively poor sensitivity of p24 antigen assays and the absence of readily available commercial, FDA-approved reagents.…”

Section: P24 Antigen Assaysmentioning

confidence: 99%

“…It should be noted that the ultrasensitive p24 antigen assay performed on plasma samples for diagnostic purposes has a sensitivity of 97% to 100% within the first 6 months of life. 81,85,89,92 However, this assay has not yet been widely recommended for identification or exclusion of HIV-1 infection in infants in the United States, but it may have a role in infant diagnosis in resource-limited settings.…”

Section: P24 Antigen Assaysmentioning

confidence: 99%

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

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2007

Pediatrics

120

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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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“…Commonly used methods rely on the detection of antibodies to HIV-1 in plasma or sera [2,[7][8][9]. Unfortunately, these techniques are of little value in the earliest stages of infection before the development of antibodies against HIV-1 (average infectious-window period of 25 days; 95% confidence interval: 9-41 days) [10][11][12][13][14] and also in neonates because maternal antibodies can persist in the newborn for up to 12 months or more [5,[15][16][17]. Detection of the major core protein of HIV-1 (p24 Gag) in serum or plasma by an ELISA is specific but does not offer the requisite sensitivity [5,6,[18][19][20][21].…”

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confidence: 99%

Detection of HIV-1 P24 Gag in Plasma by a Nanoparticle-Based Bio-Barcode-Amplification Method

et al. 2008

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Background-Detection of HIV-1 in patients is limited by the sensitivity and selectivity of available tests. The nanotechnology-based bio-barcode-amplification method offers an innovative approach to detect specific HIV-1 antigens from diverse HIV-1 subtypes. We evaluated the efficacy of this protein-detection method in detecting HIV-1 in men enrolled in the Chicago component of the Multicenter AIDS Cohort Study (MACS).

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Prospective Evaluation of Amplification‐Boosted ELISA for Heat‐Denatured p24 Antigen for Diagnosis and Monitoring of Pediatric Human Immunodeficiency Virus Type 1 Infection

Cited by 74 publications

References 23 publications

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

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

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

Detection of HIV-1 P24 Gag in Plasma by a Nanoparticle-Based Bio-Barcode-Amplification Method

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