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KAIS 2007 1 - Kenya National AIDS & STI Control Programme ...

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Red top (5 ml)Whole blood collectedDBS (alternative)Green top (2 ml)HouseholdSerum vial #1(0.5 ml)Serum vial #2(1.0 ml)Serum vial #3(1.5 ml)ClotDBS(25 μl)Field labDry shipper(-80 º C)Cool box(Padded with ice packs)Separate package(room temperature)TransitCentral laboratory processThe central laboratory in Nairobi was responsible for coordinating all laboratory logistics forthe survey including securing supplies for the field laboratory activities, receiving, archivingand processing samples, testing, coordinating with the quality assurance laboratory, anddispatching testing results to NASCOP.Receipt of specimens at central laboratory. An average of 500 samples from the eightprovinces were received at the NHRL each week and logged into a laboratory informationmanagement system (LIMS) using an automated barcode reader. The specimen barcodelabels were cross‐checked against the sample tracking form. Core laboratory staff checkedthe integrity of the samples and recorded this information in the LIMS (e.g. satisfactory,haemolysed, contaminated). Overall, 98.9% of whole blood samples and 99.8% of serumsamples collected in the <strong>2007</strong> <strong>KAIS</strong> were of adequate quality for testing. The three serumcryovials, which were marked for testing, quality assurance or long‐term storage weresorted and forwarded to the appropriate stations for testing or archiving.Specimen testing. The following section summarises the testing protocols followed at theNHRL and KEMRI quality assurance (QA) laboratories:HIV testing. Specimens were first tested at the NHRL according to the manufacturer’srecommendations using a fourth‐generation HIV enzyme linked immunoassay (EIA)(Vironostika HIV‐1/2 antigen/antibody) for screening and a third‐generation EIA (MurexHIV.1.2.O) for confirmation in a serial testing algorithm. The screening test wascompleted within 24 hours of logging‐in the specimen into the LIMS, and seropositivesamples were referred for immediate CD4 testing. The HIV confirmatory test wascompleted the same day or one day later. Samples showing discordant results weretested again with the two assays. Polymerase chain reaction (PCR) testing (Roche HIV<strong>KAIS</strong> <strong>2007</strong> 288

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