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Lal AA , Rajvanshi H , Jayswar H , Das A , Bharti PK , 2019. Malaria elimination: using past and present experience to make malaria-free India by 2030. J Vector Borne Dis 56: 60–65.
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Barber BE , William T , Grigg MJ , Yeo TW , Anstey NM , 2013. Limitations of microscopy to differentiate Plasmodium species in a region co-endemic for Plasmodium falciparum, Plasmodium vivax and Plasmodium knowlesi. Malar J 12: 8.
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National Center for Vector-Borne Disease Control, 2007. Manual on Quality Assurance for Laboratory Diagnosis of Malaria: Rapid Diagnostic Tests. Available at: https://ncvbdc.mohfw.gov.in/WriteReadData/l892s/SOP-Quality-Assurance-RDT.pdf. Accessed March 11, 2023.
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Rahi M , Sharma A , 2021. Free market availability of rapid diagnostics will empower communities to control malaria in India. Am J Trop Med Hyg 105: 281–283.
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National Center for Vector-Borne Disease Control, 2011. Guidelines for Bivalent RDT. Available at: https://ncvbdc.mohfw.gov.in/WriteReadData/l892s/guidelines-for-bivalent-rdt.pdf. Accessed March 11, 2023.
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Srivastava B et al., 2023. Quality assurance of malaria rapid diagnostic tests: an aid in malaria elimination. Indian J Med Res 157:23–29.
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World Health Organisation , 2020. Method Manual for Laboratory Quality Control Testing of Malaria Rapid Diagnostic Tests. Available at: https://cdn.who.int/media/docs/default-source/malaria/methods-manual-laboratory-quality-control-testing-malaria-rdt. Accessed March 11, 2023.
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Gatton ML , Rees-Channer RR , Glenn J , Barnwell JW , Cheng Q , Chiodini PL , Incardona S , González IJ , Cunningham J , 2015. Pan-Plasmodium band sensitivity for Plasmodium falciparum detection in combination malaria rapid diagnostic tests and implications for clinical management. Malar J 14: 1–8.
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Benefits of Lot Testing to Improve the Quality of Malaria Rapid Diagnostic Tests in India
Bina Srivastava
Bina Srivastava
Indian Council of Medical Research, National Institute of Malaria Research, Dwarka, New Delhi, India;
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Supriya Sharma
Supriya Sharma
Indian Council of Medical Research, National Institute of Malaria Research, Dwarka, New Delhi, India;
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Deendayal Swarnkar
Deendayal Swarnkar
Indian Council of Medical Research, National Institute of Malaria Research, Dwarka, New Delhi, India;
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Naseem Ahmed
Naseem Ahmed
Indian Council of Medical Research, National Institute of Malaria Research, Dwarka, New Delhi, India;
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Neena Valecha
Neena Valecha
Independent Malaria Technical Expert, New Delhi, India
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Anupkumar R. Anvikar
Anupkumar R. Anvikar
Indian Council of Medical Research, National Institute of Malaria Research, Dwarka, New Delhi, India;
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ABSTRACT.
Since 2010, malaria rapid diagnostic tests (RDTs) are widely used to detect malaria. The Indian Council of Medical Research–National Institute of Malaria Research performed lot testing (LT) according to WHO procedures since 2016. Lot testing is performed to evaluate the lot-to-lot variation in performance of malaria RDTs. Four sets of positive quality control (QC) panels for P. falciparum (Pf) and P. vivax (Pv) and 10 negative panels tested RDTs. RDTs were reported as pass, failed, or deferred on the basis of WHO criteria. In the past 5 years, 275 lots containing 15,488 RDT kits for malaria diagnosis were subjected to LT. The monovalent RDTs (n = 1,216), based on either Pf histidine rich protein 2 (HRP2) or Pan-Plasmodium lactate dehydrogenase (Pan-pLDH) antigens, showed 90.4% sensitivity and 100% specificity, whereas RDTs based on HRP2 + Pan-pLDH or HRP2 + pLDH (n = 13,924) had sensitivity 95.6% and specificity 99.5%, respectively. RDTs based on PfHRP2 + Pv-pLDH + Pan-pLDH (n = 348) had 100% sensitivity and specificity. In a comparison between HRP2 + pLDH or HRP2 + Pan-pLDH to HRP2 + pLDH + Pan-pLDH RDTs, it was found that the sensitivity of PfHRP2 with Pan-pLDH RDTs (n = 2,382) was only 83%. Of the 275 lots analyzed, 15 lots of PfHRP2 with Pan-pLDH were deferred. The QC panel for Pf revealed a faint Pan band in the tested lots, which is a cause for concern. The results of deferred lots were reported to concerned government agencies. Quality-compromised RDTs may lead to an incorrect diagnosis. It is critical to have a QC system in place for effective malaria management.
- Supplemental Materials (PDF 751.09 KB)
Author Notes
Disclosure: RDT suppliers cover lot testing expenditures for tested products. However, they have no say in the analysis, interpretation, or dissemination of the result of the study.
Authors’ contributions: Conceptualization—B. Srivastava, S. Sharma, A. R. Anvikar. Data curation—D. Swarnkar, N. Ahmed. Formal analysis—D. Swarnkar, Methodology: B. Srivastava, S. Sharma. Project administration and supervision—AR Anvikar. Resources—N. Ahmed. Writing, reviewing and editing—B. Srivastava, S. Sharma, A. R. Anvikar. Critical Review: N. Valecha.
Authors’ addresses: Bina Srivastava, Supriya Sharma, Deendayal Swarnkar, Naseem Ahmed, and Anupkumar R. Anvikar, Indian Council of Medical Research-National Institute of Malaria Research, Dwarka, New Delhi, India, E-mails: shbira@gmail.com, supsmicro@gmail.com, deendayal.soni10@gmail.com, nks.nimr@gmail.com, and anvikar@gmail.com. Neena Valecha, Independent Malaria Technical Expert, New Delhi, India, E-mail: neenavalecha@gmail.com.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
World Health Organization, 2022. World Malaria Report. Available at: https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2022. Accessed March 11, 2023.
-
2.
Lal AA , Rajvanshi H , Jayswar H , Das A , Bharti PK , 2019. Malaria elimination: using past and present experience to make malaria-free India by 2030. J Vector Borne Dis 56: 60–65.
-
3.
Barber BE , William T , Grigg MJ , Yeo TW , Anstey NM , 2013. Limitations of microscopy to differentiate Plasmodium species in a region co-endemic for Plasmodium falciparum, Plasmodium vivax and Plasmodium knowlesi. Malar J 12: 8.
-
4.
National Center for Vector-Borne Disease Control, 2007. Manual on Quality Assurance for Laboratory Diagnosis of Malaria: Rapid Diagnostic Tests. Available at: https://ncvbdc.mohfw.gov.in/WriteReadData/l892s/SOP-Quality-Assurance-RDT.pdf. Accessed March 11, 2023.
-
5.
Rahi M , Sharma A , 2021. Free market availability of rapid diagnostics will empower communities to control malaria in India. Am J Trop Med Hyg 105: 281–283.
-
6.
National Center for Vector-Borne Disease Control, 2011. Guidelines for Bivalent RDT. Available at: https://ncvbdc.mohfw.gov.in/WriteReadData/l892s/guidelines-for-bivalent-rdt.pdf. Accessed March 11, 2023.
-
7.
Srivastava B et al., 2023. Quality assurance of malaria rapid diagnostic tests: an aid in malaria elimination. Indian J Med Res 157:23–29.
-
8.
World Health Organisation , 2016. Methods Manual for Product Testing of Malaria Rapid Diagnostic Tests. Available at: https://cdn.who.int/media/docs/default-source/malaria/rdt-method-manual-product-testing. Accessed March 11, 2023.
-
9.
World Health Organisation , 2020. Method Manual for Laboratory Quality Control Testing of Malaria Rapid Diagnostic Tests. Available at: https://cdn.who.int/media/docs/default-source/malaria/methods-manual-laboratory-quality-control-testing-malaria-rdt. Accessed March 11, 2023.
-
10.
Gatton ML et al., 2020. Impact of Plasmodium falciparum gene deletions on malaria rapid diagnostic test performance. Malar J 19: 1–11.
-
11.
Incardona S et al., 2020. Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests. Malar J 19: 1–7.
-
12.
Maltha J , Gillet P , Bottieau E , Cnops L , van Esbroeck M , Jacobs J , 2010. Evaluation of a rapid diagnostic test (CareStart Malaria HRP-2/pLDH (Pf/pan) Combo Test) for the diagnosis of malaria in a reference setting. Malar J 9: 171–175.
-
13.
Gatton ML , Rees-Channer RR , Glenn J , Barnwell JW , Cheng Q , Chiodini PL , Incardona S , González IJ , Cunningham J , 2015. Pan-Plasmodium band sensitivity for Plasmodium falciparum detection in combination malaria rapid diagnostic tests and implications for clinical management. Malar J 14: 1–8.
-
14.
Hawkes M et al., 2014. Use of a three-band HRP2/pLDH combination rapid diagnostic test increases diagnostic specificity for falciparum malaria in Ugandan children. Malar J 13: 43.
-
15.
Hopkins H , Kambale W , Kamya MR , Staedke SG , Dorsey G , Rosenthal PJ , 2007. Comparison of HRP2- and pLDH-based rapid diagnostic tests for malaria with longitudinal follow-up in Kampala, Uganda. Am J Trop Med Hyg 76:1092–1097.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1305 | 1305 | 38 |
| Full Text Views | 42 | 42 | 1 |
| PDF Downloads | 45 | 45 | 1 |