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

Malaria Journal

Research

Ann M. Buff¹  Elizabeth Wanja²  Derek R. Monthei²  Victor Otieno³  Rachel Achilla³  Peter Obare³  Caroline Moseti³  Rose Adeny³  Collins Morang’a³  Bernhards Ogutu³  Ephantus Murigi⁴  John Nyamuni⁴ 

[1] Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, MS A-06, 30333, Atlanta, GA, USA;U.S. President’s Malaria Initiative, P. O. Box 606, United Nations Avenue, Village Market, 00621, Nairobi, Kenya;Malaria Diagnostics Center, U.S. Army Medical Research Directorate-Kenya, Box 54, 40100, Kisumu, Kenya;Malaria Diagnostics Center, U.S. Army Medical Research Directorate-Kenya, Box 54, 40100, Kisumu, Kenya;Malaria Diagnostics Center, Kenya Medical Research Institute, Box 54, 40100, Kisumu, Kenya;National Malaria Control Programme, Ministry of Health, P.O. Box 19982, 00200, Nairobi, Kenya;

关键词: Malaria;    Microscopy;    Quality assurance;    Accuracy;    Laboratory;    Kenya;   

DOI  :  10.1186/s12936-017-1856-2

 received in 2016-11-01, accepted in 2017-05-12,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundOne 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.MethodsFrom 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.ResultsEighty (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 < 0.001). Reference material availability also increased significantly; availability of six microscopy job aids and seven microscopy standard operating procedures increased by a mean of 32 percentage points (p < 0.001) and 38 percentage points (p < 0.001), respectively.ConclusionsSignificant gains were observed in malaria QA/QC practices over the pilot. However, these advances did not translate into improved accuracy of malaria diagnostic performance perhaps because of the limited duration of the QA pilot implementation.

【 授权许可】

CC BY   
© The Author(s) 2017