Viral load assay performs comparably to early infant diagnosis assay to diagnose infants with HIV in Mozambique: a prospective observational study

Introduction: We determine the level of adherence to the revised Kenya early infant diagnosis (EID) algorithm during implementation of a point-of-care (POC) EID project. Methods: Data before (August 2016 to July 2017) and after (August 2017 to July 2018) introduction of POC EID were collected retrospectively from the national EID database and registers for 33 health facilities. We assessed the number of HIV-infected infants who underwent confirmatory testing and received baseline viral load test and proportion of infants with an initial negative result who had a subsequent test. Results and Discussion: Significantly higher number of infants accessed confirmatory testing (94.2% versus 38.6%; P < .0001) with POC EID. Baseline viral load test and follow-up testing at 6 months, although higher with POC EID, were not significantly different from the pre-POC EID intervention period. Conclusion: The POC EID implementation has the potential to increase proportion of infants who receive confirmatory testing, thus reducing the risk of false-positive results.

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Results of Baseline Assessments of Two Viral Load and Early Infant Diagnosis Laboratories in Gaza Province, Mozambique

American Journal of Clinical Pathology ◽

10.1093/ajcp/aqz115.001 ◽

2019 ◽

Vol 152 (Supplement_1) ◽

pp. S79-S79

Author(s):

Augusto Nhabomba ◽

Mariamo Assane ◽

Noorbebi Adamo ◽

Octavia Benzane ◽

Isabel Pinto ◽

...

Keyword(s):

Viral Load ◽

Scale Up ◽

Hiv Prevalence ◽

Internal Quality ◽

Early Infant Diagnosis ◽

Hiv Viral Load ◽

Early Infant ◽

Sample Management ◽

Basic Infrastructure

Abstract Following the WHO 2013 recommendations for routine HIV viral load (VL) testing as the tool to monitor antiretroviral therapy, countries have prepared for massive testing scale-up. However, developing countries that also bear the highest HIV prevalence often lack qualified human resources and basic infrastructure. Mozambique has established 13 VL laboratories, including 2 in the province with the highest overall HIV prevalence, Gaza. The challenges to VL testing implementation and this rapid scale-up demand an urgent investment toward laboratory accreditation to ensure accurate and reliable VL results. To identify gaps and areas for improvement where additional resources may be needed to provide high-quality VL testing services, the CDC developed a VL and Early Infant Diagnosis (EID) scorecard (106 points; 5 levels). The scorecard evaluates 9 key areas, including (1) Personnel, (2) Facility/Environment, (3) Safety, (4) Procurement/Inventory, (5) Sample Management, (6) Equipment, (7) Process Control, (8) M&E Documents and Records, and (9) Internal Quality Audits/Quality Indicators. These 9 essential areas cover the pretesting, testing, and posttesting phases along the continuum of care for HIV patients. Baseline assessments in the two VL and EID laboratories in Gaza Province, Carmelo Molecular Laboratory and Xai-Xai Molecular Laboratory, were recently conducted. Personnel standards and M&E documentation represented strengths across both laboratories, with over 70% of the master list of M&E documents having been developed and in use. The overall gaps identified included poor segregation and prioritization of higher VL results (>1,000 cp/mL), lack of internal audits, and no follow-up of nonconformities. Both laboratories scored in the level 2 range, with a total of 68 points (Carmelo) and 78 points (Xai-Xai). Considering this is a baseline assessment, we conclude that both labs are on an excellent path toward accreditation; however, additional laboratory quality mentorship is needed in order to reach accreditation standards.

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