Analysis of the optimal cut-point for HIV-p24 antigen testing to diagnose HIV infection in HIV-exposed children from resource-constrained settings

Tamhane, Mayur C.; Gautney, Brad; Shiu, Carlum; Segaren, N.; Jeannis, L.; Eustache, C.; Simeon-Fadois, Y.; Chen, Y.H.; D, de la Rosa; Irivinti, S.; Thompson, C.B.; Khamadi, Samoel; Siberry, George K.; Persaud, Deborah

doi:10.1016/j.jcv.2011.01.012

Cited by 4 publications

(3 citation statements)

References 21 publications

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“…Early diagnosis of HIV allows health care providers to offer optimal care and treatment of HIV-infected children, assists in decision-making on infant feeding, and reduces illness-related stress in mothers and families. The increasing efficacy and coverage of Prevention of Mother-to-Child Transmission of HIV (PMTCT) interventions have resulted in the majority of children born to HIV-infected mothers being HIV-free [ 5 ]. Consequently, identification of infected children before the illness is possible through routine diagnostic testing of all exposed infants.…”

Section: Introductionmentioning

confidence: 99%

Early Infant Diagnosis Sample Management in Mashonaland West Province, Zimbabwe, 2017

Mugauri

Mugurungi

Chadambuka³

et al. 2018

AIDS Research and Treatment

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Background In 2016, Mashonaland West Province had 7.4% (520) dried blood spot (DBS) samples for early infant diagnosis (EID) rejected by the Zimbabwe National Microbiology Reference Laboratory (NMRL). The samples were suboptimal, delaying treatment initiation for HIV-infected children. EID is the entry point to HIV treatment services in exposed infants. We determined reasons for DBS sample rejections and suggested solutions. Methods A cause-effect analysis, modelled on Ishikawa, was used to identify factors impacting DBS sample quality. Interviewer-administered questionnaires and evaluation of sample collection process, using Standard Operating Procedure (SOP) was conducted. Rejected samples were reviewed. Epi Info™ was used to analyze findings. Results Eleven (73.3%) facilities did not adhere to SOP and (86.7%) did not evaluate DBS sample quality before sending for testing. Delayed feedback (up to 4 weeks) from NMRL extended EID delay for 14 (93.3%) of the facilities. Of the 53 participants, 62% knew valid sample identification. Insufficient samples resulted in most rejections (77.9%). Lack of training (94.3%) and ineffective supervision (69.8%) were also cited. Conclusion Sample rejections could have been averted through SOP adherence. Ineffective supervision, exacerbated by delayed communication of rejections, extended EID delay, disadvantaging potential ART beneficiaries. Following this study, enhanced quality control through perstage evaluations was recommended to enhance DBS sample quality.

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Section: Introductionmentioning

confidence: 99%

Early Infant Diagnosis Sample Management in Mashonaland West Province, Zimbabwe, 2017

Mugauri

Mugurungi

Chadambuka³

et al. 2018

AIDS Research and Treatment

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“…Currently, third generation tests have lower false-positive rates compared to fourth generation tests, suggesting that laboratory-based screening should instead be used for those at high risk of infection [137]. Tamhane et al suggested adjusting positive readout thresholds in order to optimize a modified ELISA for a given prevalence (using receiver-operator curves) but this approach would be difficult to implement in simple PoC tests [161]. Use in resource-poor settings.…”

Section: Lessons Learntmentioning

confidence: 99%

p24 revisited

Gray

Bain

Varsaneux

et al. 2018

Aids

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: Despite major advances in HIV testing, early detection of infection at the point of care (PoC) remains a key challenge. Although rapid antibody PoC and laboratory-based nucleic acid amplification tests dominate the diagnostics market, the viral capsid protein p24 is recognized as an alternative early virological biomarker of infection. However, the detection of ultra-low levels of p24 at the PoC has proven challenging. Here we review the landscape of p24 diagnostics to identify knowledge gaps and barriers and help shape future research agendas. Five hundred and seventy-four research articles to May 2018 that propose or evaluate diagnostic assays for p24 were identified and reviewed. We give a brief history of diagnostic development, and the utility of p24 as a biomarker in different populations such as infants, the newly infected, those on preexposure prophylaxis and self-testers. We review the performance of commercial p24 assays and consider elements such as immune complex disruption, resource-poor settings, prevalence, and assay antibodies. Emerging and ultrasensitive assays are reviewed and show a number of promising approaches but further translation has been limited. We summarize studies on the health economic benefits of using antigen testing. Finally, we speculate on the future uses of high-performance p24 assays, particularly, if available in self-test format.

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“…The Prevention of Mother-to-Child Transmission of HIV (PMTCT) program has added value to the efficiency and wide reach of interventions which has resulted in the huge number of exposed infants born without the virus [16]. Nevertheless, early detection of infants before disease strikes can be achieved through routine diagnostic checks of all exposed infants, prioritizing TAT, since prolonged TAT may result in mortality.…”

Section: Introductionmentioning

confidence: 99%

Quality Indicator Measures as It Affects Turnaround Time (TAT) in A Molecular Laboratory in Port Harcourt, Rivers State

et al. 2021

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Background: Turnaround Time (TAT) is an important Quality Indicator in the medical laboratory. The Rivers State University Teaching Hospital (RSUTH) Polymerase Chain Reaction (PCR) laboratory was enrolled in the process of World Health Organisation (WHO) - Regional Office for Africa (AFRO) accreditation by FHi360 in preparation for the ISO 15189 accreditation in 2016. One of the services rendered in the laboratory is Early Infant Diagnosis (EID)/Dried Blood Spots (DBS) in Human Immunodeficiency Virus (HIV) exposed infants. Clinicians depend on these results to determine the next step for the management of HIV exposed Infants. This study is aimed at assessing the rate of sample rejection (SR), determine the effect of specific intervention on this rate and the effect of SR on TAT. Method: It involves the assessment of samples delivered to the RSUTH PCR Laboratory from January 2019 to March 2020. A baseline rate of sample rejection was established from January to July 2019. Interventional measures were put in place such as introducing the national algorithm for rejection and acceptance of samples, training was also done for EID sample collectors and a final assessment of changes in the rate of sample rejection was determined at the final period of January to March 2020.Results: During the baseline period, sample rejection rate started at 5% in February and went back to 0% in March. In April however, the rate of rejection increased to 9%. There was a decline in rejection rate to 5% and 7% in May and June respectively. A sudden spike in rejection occurred in July at a rate of 19%. The major reasons for sample rejection were DBS cards with insufficient blood spots, DBS cards with clots present in spots, DBS cards that have serum rings and grossly haemolysed DBS. After baseline data was collected and interventions put in place. Sample rejection rate drastically reduced to 1%, 0% and 0% respectively from January to March which is way below the maximum threshold of 2% as advocated by WHO. At baseline EID, TAT was longer than a month, however; with SR, the TAT increased to about seven weeks. The final assessment in March from this study showed a significant reduction in sample rejection to 0%.Conclusion and recommendations: This study has shown that quality improvement is achievable if interventional tools are utilized promptly. This will result in shorter TAT; fewer samples rejected and therefore prompt treatment of exposed infants thus reducing morbidity and mortality due to HIV.

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Analysis of the optimal cut-point for HIV-p24 antigen testing to diagnose HIV infection in HIV-exposed children from resource-constrained settings

Cited by 4 publications

References 21 publications

Early Infant Diagnosis Sample Management in Mashonaland West Province, Zimbabwe, 2017

Early Infant Diagnosis Sample Management in Mashonaland West Province, Zimbabwe, 2017

p24 revisited

Quality Indicator Measures as It Affects Turnaround Time (TAT) in A Molecular Laboratory in Port Harcourt, Rivers State

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