Evaluation of a laboratory quality assurance pilot programme for malaria diagnostics in low-transmission areas of Kenya, 2013

• Published in: Malaria journal 2017-05, Vol.16 (1), p.221-221, Article 221
• Main Authors: Wanja, Elizabeth, Achilla, Rachel, Obare, Peter, Adeny, Rose, Moseti, Caroline, Otieno, Victor, Morang'a, Collins, Murigi, Ephantus, Nyamuni, John, Monthei, Derek R, Ogutu, Bernhards, Buff, Ann M
• Format: Article
• Language: English
• Subjects: Accuracy; Availability; Diagnostic Tests, Routine - methods; Disease transmission; Health facilities; Health Facilities - statistics & numerical data; Human diseases; Humans; Kenya; Laboratories; Laboratories - statistics & numerical data; Laboratory; Laboratory equipment; Malaria; Malaria - diagnosis; Medical research; Microscopy; Microscopy - methods; Parasites; Personnel; Pilot Projects; Procedures; Quality assurance; Quality Control; Reference materials; Scaling; Sensitivity and Specificity; Specificity; Training; Vector-borne diseases; Workers
• ISSN: 1475-2875; 1475-2875
• DOI: 10.1186/s12936-017-1856-2

One objective of the Kenya National Malaria Strategy 2009-2017 is scaling access to prompt diagnosis and effective treatment. In 2013, a quality assurance (QA) pilot was implemented to improve accuracy of malaria diagnostics at selected health facilities in low-transmission counties of Kenya. Trends in malaria diagnostic and QA indicator performance during the pilot are described. From June to December 2013, 28 QA officers provided on-the-job training and mentoring for malaria microscopy, malaria rapid diagnostic tests and laboratory QA/quality control (QC) practices over four 1-day visits at 83 health facilities. QA officers observed and recorded laboratory conditions and practices and cross-checked blood slides for malaria parasite presence, and a portion of cross-checked slides were confirmed by reference laboratories. Eighty (96%) facilities completed the pilot. Among 315 personnel at pilot initiation, 13% (n = 40) reported malaria diagnostics training within the previous 12 months. Slide positivity ranged from 3 to 7%. Compared to the reference laboratory, microscopy sensitivity ranged from 53 to 96% and positive predictive value from 39 to 53% for facility staff and from 60 to 96% and 52 to 80%, respectively, for QA officers. Compared to reference, specificity ranged from 88 to 98% and negative predictive value from 98 to 99% for health-facility personnel and from 93 to 99% and 99%, respectively, for QA officers. The kappa value ranged from 0.48-0.66 for facility staff and 0.57-0.84 for QA officers compared to reference. The only significant test performance improvement observed for facility staff was for specificity from 88% (95% CI 85-90%) to 98% (95% CI 97-99%). QA/QC practices, including use of positive-control slides, internal and external slide cross-checking and recording of QA/QC activities, all increased significantly across the pilot (p