External quality assessment on the use of malaria rapid diagnostic tests in a non-endemic setting

Gillet, Philippe; Mukadi, Pierre; Vernelen, Kris; Esbroeck, Marjan Van; Muyembe, Jean‐Jacques; Bruggeman, Cathrien A.; Jacobs, Jan

doi:10.1186/1475-2875-9-359

Cited by 34 publications

(38 citation statements)

References 33 publications

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“…This observation is in line with what was previously recorded in the same setting [15]. Given the non-perfect performance of RDTs (and in particular the false-negatives at low P .…”

Section: Discussionsupporting

confidence: 92%

Photo-based External Quality Assessment of Malaria rapid diagnostic tests in a non-endemic setting

et al. 2018

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IntroductionIn non-endemic settings, expertise in malaria microscopy is limited and rapid diagnostic tests (RDTs) are an adjunct to malaria diagnosis.AimWe performed an External Quality Assessment (EQA) on reading and interpretation of malaria RDTs in a non-endemic setting.MethodsParticipants were medical laboratories in Belgium and the Grand Duchy of Luxembourg using malaria RDTs; they received (i) 10 high-resolution photographs presenting test line combinations of RDTs with interpretations listed in a multiple choice format and (ii) a questionnaire about their practices of malaria diagnosis.ResultsAmong 135 subscribing laboratories, 134 (99.3%) used 139 RDT products (11 different products from 8 brands). After exclusion of the results of one laboratory, analysis was done for 133 laboratories using 137 RDT products. Scores of 10/10, 9/10 and 8/10 were achieved for 58.4%, 13.1% and 8.0% of 137 RDT products respectively. For three-band P. falciparum–pan-Plasmodium RDTs (113 (82.5%) products, 6 brands), most frequent errors were (1) disregarding faint test lines (18.6%), (2) reporting invalid instead of P. falciparum (16.8%) and (3) reporting “Plasmodium spp., no further differentiation possible” without mentioning the presence or absence of P. falciparum (11.5%). For four-band RDTs (21 (15.3%) products, 1 brand), errors were (4) disregarding faint P. vivax test lines (47.6%) and (5) reporting “Plasmodium spp., no further differentiation possible” without mentioning the presence of P. falciparum and P. vivax (28.6%). Instructions for use (IFU) of only 4 out of 10 RDT products mentioned to interpret faint-intensity test lines as positive (conducive to errors 1 and 4) and IFU of 2 products displayed incorrect information (conducive to errors 2 and 5). Outside of office hours, 36.1% of participants relied on RDTs as the initial diagnostic test; 13.9% did not perform microscopic confirmation.ConclusionReading and interpretation of malaria RDTs was satisfactory, but errors were embedded in the instructions for use of the products. Relying on RDTs alone for malaria diagnosis (about one third of participants) is not a recommended practice.

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“…This observation is in line with what was previously recorded in the same setting [15]. Given the non-perfect performance of RDTs (and in particular the false-negatives at low P .…”

Section: Discussionsupporting

confidence: 92%

Photo-based External Quality Assessment of Malaria rapid diagnostic tests in a non-endemic setting

et al. 2018

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“…McMorrow et al noted that quality monitoring of RDTs using poor quality blood films might undermine confidence in RDT use ( 66 ). Blood samples for malaria antigens for RDT PT must be stored at 4 °C for a maximum of 48 hours, or for longer at –70 °C ( 67 ). Methods for preparing stable positive controls from cultured P. falciparum using DBS and dried tube specimens (DTS) have been demonstrated ( 68 , 69 ).…”

Section: Resultsmentioning

confidence: 99%

External quality assessment in resource–limited countries

Carter

2017

Biochem Med

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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.

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“…Many of the errors with malaria RDT kit are related to the post-analytical phase, i.e. wrong reading of the test and control lines and incorrect interpretation of the results [45, 46]. Therefore, quality assessment on the use of malaria RDT test in pharmacies should be promoted through monitoring.…”

Section: Discussionmentioning

confidence: 99%

Cost benefit analysis of malaria rapid diagnostic test: the perspective of Nigerian community pharmacists

Ezennia

Nduka

Ekwunife

2017

Malar J

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Background In 2010, the World Health Organization issued a guideline that calls for a shift from presumptive to test-based treatment. However, test-based treatment is still unpopular in community pharmacies. This could be due to unwillingness of customers to spend extra finance on rapid diagnostic test (RDT). It could also result from lack of interest from community pharmacists since they may perceive no financial gain attached to this service. This study assessed the cost-benefit of test-based malaria treatment to community pharmacists. MethodsThe study was a community pharmacy-based cross sectional survey. Potential benefit of RDT was determined using customers’ willingness-to-pay (WTP) for service. Average WTP was estimated using contingent valuation. Binary logistic regression was used to assess correlates of WTP acceptance while multiple linear regression was used to model the relationship between the independent variables and WTP amount. Cost associated with provision of RDT was estimated from provider’s perspective. Probabilistic sensitivity analysis was used to capture parameter uncertainty. Benefit-cost ratio (BCR) was calculated to determine study objective.ResultsA total of 135 out of 235 participants (57.4%) responded to the WTP question. Of this subset, 111 participants (82.2%) preferred RDT before malaria treatment. Average WTP [minimum–maximum] was US$1.23 [US$0.0–US$5.03]. Educated participants had 1.8 times higher odds of WTP for RDT. Participants that understood RDT as described in the questionnaire had 18.3 times higher odds of WTP for RDT compared to participants that did not understand RDT as described in the questionnaire. Additionally, a unit increase in level of education (e.g. from primary to secondary school) led to US$0.298 increase in WTP amount for RDT. Also, a unit increase in malaria frequency (e.g. from ‘never’ to ‘rarely’) led to US$0.293 decrease in WTP amount for RDT. Average cost [minimum–maximum] of RDT test kit and pharmacist time spent in administering the test were US$0.15 [US$0.13–US$0.17] and US$0.41 [US$0.18–US$0.52], respectively. BCR of test-based malaria treatment was 6.7 (95% CI 6.4–7.0).ConclusionTest-based malaria treatment is cost-beneficial for pharmacy practitioners. This finding could be used as an advocacy tool to increase community pharmacists’ interest and uptake of test-based malaria treatment.Electronic supplementary materialThe online version of this article (doi:10.1186/s12936-016-1648-0) contains supplementary material, which is available to authorized users.

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External quality assessment on the use of malaria rapid diagnostic tests in a non-endemic setting

Cited by 34 publications

References 33 publications

Photo-based External Quality Assessment of Malaria rapid diagnostic tests in a non-endemic setting

Photo-based External Quality Assessment of Malaria rapid diagnostic tests in a non-endemic setting

External quality assessment in resource–limited countries

Cost benefit analysis of malaria rapid diagnostic test: the perspective of Nigerian community pharmacists

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