High Sensitivity and Specificity of Clinical Microscopy in Rural Health Facilities in Western Kenya Under an External Quality Assurance Program

Wafula, Rebeccah; Sang, Edna; Cheruiyot, Olympia; Aboto, Angeline; Menya, Diana; O’Meara, Wendy Prudhomme

doi:10.4269/ajtmh.14-0133

Cited by 11 publications

(11 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The observations from the QA pilot are consistent with findings from another recent external QA programme implemented in a limited number of rural health facilities in western Kenya and provide additional evidence for a coordinated approach to strengthening malaria diagnostics across the larger clinical and laboratory systems [21, 24]. Significant gains were observed in malaria diagnostic QA/QC practices over the pilot.…”

Section: Discussionsupporting

confidence: 79%

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

Wanja

Achilla

Obare

et al. 2017

Malar J

View full text Add to dashboard Cite

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12936-017-1856-2) contains supplementary material, which is available to authorized users.

show abstract

Section: Discussionsupporting

confidence: 79%

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

Wanja

Achilla

Obare

et al. 2017

Malar J

View full text Add to dashboard Cite

show abstract

“…A study from Rwanda reported excellent quality of malaria slide re-reading without grading of positive slides ( 53 ). Khan et al studied malaria slide reading performance in Pakistan after instituting three activities: on-site rechecking of malaria slides, uninterrupted availability of laboratory reagents and supplies, and supervision by district supervisors ( 54 ); Wafula et al instituted four concurrent activities in Kenya: re-reading of malaria films; feedback on quality of slide preparation; preparation of monthly laboratory performance reports; and on-the-job mentorship ( 55 ). These studies demonstrated the beneficial effects of additional support on performance.…”

Section: Resultsmentioning

confidence: 99%

External quality assessment in resource–limited countries

Carter

2017

Biochem Med

View full text Add to dashboard Cite

IntroductionHealth laboratory services are a critical component of national health systems but face major operational challenges in resource-limited (RL) settings. New funding for health systems strengthening in RL countries has increased the demand for diagnostics and provided opportunities to address these constraints. An approach to sustainably strengthen national laboratory systems in sub-Saharan African countries is the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. External Quality Assessment (EQA) is a requirement for laboratory accreditation. EQA comprises proficiency testing (PT), rechecking of samples and on-site evaluation.Materials and methodsA systematic literature search was conducted to identify studies addressing laboratory EQA and quality monitoring in RL countries. Unpublished reports were also sought from national laboratory authorities and personnel.ResultsPT schemes in RL countries are provided by commercial companies, institutions in developed countries and national programmes. Most government-supported PT schemes address single diseases using a vertical approach. Regional approaches to delivering PT have also been implemented across RL countries. Rechecking schemes address mainly tuberculosis (TB), malaria and human immunodeficiency virus (HIV); integrated rechecking programmes have been piloted. Constraints include sample transportation, communication of results, unknown proficiency of referee staff and limited resources for corrective action. Global competency assessment standards for malaria microscopists have been established.ConclusionsEQA is vital for monitoring laboratory performance and maintaining quality of laboratory services, and is a valuable tool for identifying and assessing technology in use, identifying gaps in laboratory performance and targeting training needs. Accreditation of PT providers and competency of EQA personnel must be ensured.

show abstract

“…First, for slide 1 (which contained no parasites), nearly a third (32.4%) of participants reported the presence of blood parasites. Diagnosing (or reporting) malaria in parasite-negative specimens is a well-known phenomenon and has been consistently observed in diagnostic settings in sub-Saharan Africa, with false positive rates ranging from 1.4% to 51.0% [ 5 , 24 – 26 ]. Despite this, the high proportion of blood parasites presently reported was surprising given the particular setting of an EQA session.…”

Section: Discussionmentioning

confidence: 99%

Performance of Microscopy for the Diagnosis of Malaria and Human African Trypanosomiasis by Diagnostic Laboratories in the Democratic Republic of the Congo: Results of a Nation-Wide External Quality Assessment

et al. 2016

View full text Add to dashboard Cite

The present External Quality Assessment (EQA) assessed microscopy of blood parasites among diagnostic laboratories in the Democratic Republic of the Congo. The EQA addressed 445 participants in 10/11 provinces (October 2013–April 2014). Participants were sent a panel of five slides and asked to return a routinely stained slide which was assessed for quality of preparation and staining. Response rate was 89.9% (400/445). For slide 1 (no parasites), 30.6% participants reported malaria, mostly Plasmodium falciparum. Only 11.0% participants reported slide 2 (Plasmodium malariae) correctly, 71.0% reported “malaria” or “Plasmodium falciparum” (considered acceptable). Slide 3 contained Plasmodium falciparum (109/μl) and Trypanosoma brucei brucei trypomastigotes: they were each reported by 32.5% and 16.5% participants respectively, 6.0% reported both. Slide 4 (Trypanosoma) was recognised by 44.9% participants. Slide 5 (Plasmodium ovale) was correctly reported by 6.2% participants, another 68.8% replied “malaria” or “Plasmodium falciparum” (considered acceptable). Only 13.6% of routine slides returned were correctly prepared and stained. The proportion of correct/acceptable scores for at least 4/5 slides was higher among EQA-experienced participants compared to first time participants (40.9% versus 22.4%, p = 0.001) and higher among those being trained < 2 years ago compared to those who were not (42.9% versus 26.3%, p = 0.01). Among diagnostic laboratories in Democratic Republic of the Congo, performance of blood parasite microscopy including non-falciparum species and Trypanosoma was poor. Recent training and previous EQA participation were associated with a better performance.

show abstract

High Sensitivity and Specificity of Clinical Microscopy in Rural Health Facilities in Western Kenya Under an External Quality Assurance Program

Cited by 11 publications

References 14 publications

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

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

External quality assessment in resource–limited countries

Performance of Microscopy for the Diagnosis of Malaria and Human African Trypanosomiasis by Diagnostic Laboratories in the Democratic Republic of the Congo: Results of a Nation-Wide External Quality Assessment

Contact Info

Product

Resources

About