HIV-1 ICD p24 antigen detection in Ugandan infants: Use in early diagnosis of infection and as a marker of disease progression

Guay, Laura; Hom, David L.; Kabengera, Sam; Piwowar‐Manning, Estelle; Kataaha, Peter; Ndugwa, Christopher M.; Marum, Lawrence; Kalyesubula, Israel; Jackson, J. Brooks

doi:10.1002/1096-9071(200012)62:4<426::aid-jmv6>3.0.co;2-s

Cited by 17 publications

(4 citation statements)

References 31 publications

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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%

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: P24 Antigen Assaysmentioning

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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“…Simple laboratory tests such as Total Lymphocyte Count (TLC), hemoglobin estimation, albumin, and HIV p24 antigen have been identified as possible surrogate markers for monitoring disease progression of HIV infected adults and children in developing countries [4,7]. The TLC is an inexpensive and useful marker for staging disease and predicting AIDS progression or death in HIV infected adults [8,9].…”

Section: Introductionmentioning

confidence: 99%

Total Lymphocyte Count: Not a Surrogate Marker for Risk of Death in HIV-Infected Ugandan Children

Musoke¹,

Young²,

Owor³

et al. 2008

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Objectives To determine the utility of Total Lymphocyte Count (TLC) in predicting the 12 month mortality in HIV infected Ugandan children; to correlate TLC and CD4 cell %. Design This is a retrospective data analysis of clinical and laboratory data collected prospectively on 128 HIV infected children in the HIVNET 012 trial. Methods TLC and CD4 cell % measurements were obtained at birth, 14 weeks and 12, 24, 36, 48, and 60 months of age and assessed with respect to risk of death within 12 months. Results Median TLC/ul (CD4 cell %) were 4150 (41%) at birth, 4900 (24%) at 12 months, 4300 (19%) at 24 months, 4150 (19 %) at 36 months, 4100 (18%) at 48 months and 3800 (20%) at 60 months. The highest risk of mortality within 12 months was 34–37% at birth and declined to 13–15% at 24 months regardless of TLC measurement. The correlation between CD4 cell % and TLC was extremely low overall (r = 0.01). Conclusion The TLC did not predict a risk of progression to death within 12 months and therefore TLC alone may not be a useful surrogate marker for determining those children in greatest need for antiretroviral therapy in HIV infected Ugandan children.

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“…Instead, HIV-exposed children were tested at 18 months of age with an HIV enzyme-linked immunosorbent assay to establish their HIV infection status. When the national rollout of ART in the public sector commenced in April 2004, a p24 antigen assay with a sensitivity of 50% [6] was recommended for EID to identify infants for treatment. Although PCR testing was available in three National Health Laboratory Service (NHLS) laboratories in the public health sector, it was considered too expensive and complex and was therefore restricted to clinical trial participants and abandoned children requiring adoption or foster care placement.…”

mentioning

confidence: 99%

Laboratory information system data demonstrate successful implementation of the prevention of mother-to-child transmission programme in South Africa

Sherman

Lilian

Bhardwaj³

et al. 2014

S Afr Med J

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Background. Monitoring the prevention of mother-to-child transmission (PMTCT) programme to identify gaps for early intervention is essential as South Africa progresses from prevention to elimination of HIV infection in children. Early infant diagnosis (EID) by an HIV polymerase chain reaction (PCR) test is recommended at 6 weeks of age for all HIV-exposed infants. The National Health Laboratory Service (NHLS) performs the PCR tests for the public health sector and stores test data in a corporate data warehouse (CDW). Objectives. To demonstrate the utility of laboratory data for monitoring trends in EID coverage and early vertical transmission rates and to describe the scale-up of the EID component of the PMTCT programme. Methods. HIV PCR test data from 2003 to 2012 inclusive were extracted from the NHLS CDW by year, province, age of infant tested and test result and used to calculate EID coverage and early vertical transmission rates to provincial level. Results. Rapid scale-up of EID over the first decade of the PMTCT programme was evident from the 100-fold increase in PCR tests to 350 000 by 2012. In 2012, 73% of the estimated 270 000 HIV-exposed infants requiring an early PCR were tested and the early vertical transmission rate had fallen to 2.4% as a result of successful implementation of the PMTCT programme. Conclusions. Laboratory data can provide real time, affordable monitoring of aspects of the PMTCT programme and assist in achieving virtual elimination of paediatric HIV infection in South Africa.

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HIV-1 ICD p24 antigen detection in Ugandan infants: Use in early diagnosis of infection and as a marker of disease progression

Cited by 17 publications

References 31 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

Total Lymphocyte Count: Not a Surrogate Marker for Risk of Death in HIV-Infected Ugandan Children

Laboratory information system data demonstrate successful implementation of the prevention of mother-to-child transmission programme in South Africa

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