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1. Discrepant test findings in Early Infant Diagnosis of HIV in a National Reference Laboratory in Kenya: Challenges and Opportunities for Programs

Author

Alex Maiyo, Matilu Mwau, Nancy Ndung'u, Vincent Okoth, Elphas Okapesi, Samoel Khamadi, Stella Vihenda, Sheila Kageha, Silvia Kadima, and Elizabeth Nyambura

Subjects
medicine.medical_specialty, Human immunodeficiency virus (HIV), HIV Infections, Reference laboratory, medicine.disease_cause, Polymerase Chain Reaction, Sensitivity and Specificity, Specimen Handling, Internal medicine, medicine, Humans, False Positive Reactions, Child, Dried blood, Blood Specimen Collection, business.industry, HIV, Infant, Reproducibility of Results, Prevention of mother to child transmission, Viral Load, Kenya, Antiretroviral therapy, Test (assessment), Early Diagnosis, Infectious Diseases, Child, Preschool, DNA, Viral, Pediatrics, Perinatology and Child Health, Immunology, HIV-1, RNA, Viral, Female, Reagent Kits, Diagnostic, Indeterminate, business, Viral load, Program Evaluation
Abstract

BACKGROUND In Kenya, the availability of a cheap diagnostic service for HIV-exposed infants has helped scale-up access to treatment, and provided a means by which programs that support Prevention of Mother to Child Transmission of HIV can be evaluated. As expected for any large testing program, discrepant and indeterminate results present a significant challenge. METHODS Dried Blood Spots were collected from health centers countrywide and couriered to four laboratories for tests. Results were dispatched either by email, telephone, GSM SMS printer or courier. Between 2006 and 2009, tests were conducted with the Manual Roche v. 1.5 Assay. In 2010 the labs switched fully to the Cobas® AmpliPrep/ Cobas® TaqMan® HIV-1 Qual automated Roche Test. RESULTS Between 2006 and 2010, the KEMRI CVR EID Lab conducted 64 591 HIV tests in on children

Published
2011
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2. Evaluation of PIMA™® Point of Care Technology for CD4 T Cell Enumeration in Kenya

Author

Mary Waihenya, Jackson Hungu, Lucy Okubi, Carolyne Kirwaye, Najma Salim Abubakr, Silvia Kadima, Matilu Mwau, Ephantus Njagi, Ferdinard Adungo, and Judi Lusike

Subjects
Adult, CD4-Positive T-Lymphocytes, Male, Pediatrics, medicine.medical_specialty, Drugs and Devices, Viral Diseases, Adolescent, Coefficient of variation, Immune Cells, Point-of-Care Systems, lcsh:Medicine, Cell Count, Medical Devices, Young Adult, Diagnostic Medicine, Internal medicine, Enumeration, Medicine, Humans, lcsh:Science, Child, Point of care, Aged, Immune status, Multidisciplinary, Cd4 t cell, business.industry, T Cells, lcsh:R, Diagnostic test, HIV, Infant, Repeatability, Middle Aged, Antiretroviral therapy, Kenya, Clinical Laboratory Sciences, Infectious Diseases, Child, Preschool, Linear Models, lcsh:Q, Clinical Immunology, Female, business, Research Article, Test Evaluation
Abstract

CD4+ T cell enumeration is used to determine eligibility for antiretroviral therapy (ART) and to monitor the immune status of HIV-positive patients; however, many patients do not have access to this essential diagnostic test. Introducing point of care (POC) testing may improve access. We have evaluated Alere's PIMA™, one such POC device, against conventional CD4+ testing platforms to determine its performance and validity for use in Kenya. In our hands, Alere PIMA™ had a coefficient of variability of 10.3% and of repeatability of 175.6 cells/µl. It differed from both the BD FACSCalibur™ (r(2) = 0.762, mean bias -64.8 cells/µl), and the BD FACSCount™ (r(2) = 0.874, mean bias 7.8 cells/µl). When compared to the FACSCalibur™ at a cutoff of 350 cells/µl, it had a sensitivity of 89.6% and a specificity of 86.7% in those aged 5 years and over (Kw = 0.7566). With the BD FACSCount™, it had a sensitivity of 79.4% and a specificity of 83.4% in those aged 5 years and over (Kw = 0.7790). The device also differed from PARTEC Cyflow™ (r(2) = 0.781, mean bias -24.2 cells/µl) and GUAVA™ (r(2) = 0.658, mean bias -0.3 cells/µl) platforms, which are used in some facilities in Kenya. We conclude that with refinement, Alere PIMA™ technology has potential benefits for HIV-positive patients. This study highlights the difficulty in selecting the most appropriate reference technology for technical evaluations.

Published
2013

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