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Open Access Research

Diagnostic performance of CareStart™ malaria HRP2/pLDH (Pf/pan) combo test versus standard microscopy on falciparum and vivax malaria between China-Myanmar endemic borders

Sun Xiaodong1, Ernest Tambo2*, Wei Chun1, Cheng Zhibin3, Deng Yan1, Wang Jian1, Wang Jiazhi4 and Zhou Xiaonong2

Author Affiliations

1 Yunnan Institute of Parasitic Diseases, Yunnan Center for Malaria Research, Institute of Vector and Pathogen Biology of Dali University, Puer, Yunnan, 665000, China

2 National Institute of Parasitic Diseases, Chinese Center for Diseases Control and Prevention, WHO Collaborating Center on Malaria, Schisostomiasis and Filariasis, Shanghai, 200025, China

3 Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100005, China

4 Tengchong Center for Disease Control and Prevention, Tengchong, Yunnan, 679100, China

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Malaria Journal 2013, 12:6  doi:10.1186/1475-2875-12-6

Published: 7 January 2013

Abstract

Background

Rapid diagnostic test (RDT) is becoming an alternative way of establishing quickly the diagnosis of malaria infections, by detecting specific malaria antigens in suspected patients’ blood between the China-Myanmar endemic borders areas, towards achieving the National Malaria Elimination programme by 2020. The objective of this study is to evaluate the performance of CareStart™ Malaria Pf/Pan RDT kit for the diagnosis of malaria infections in suspected patients. Blood examination by microscopy was taken as gold standard to evaluate CareStart™ kit’s sensitivity, specificity and predictive value and corrected with PCR assay.

Results

Overall 126 of 241 (52.28%) malaria cases were detected by microscopy compared to 115 of 241(47.72%) CareStart™ kit and 128 of 241 (53.11%) PCR corrected assay. CareStart™ kit’s sensitivity and specificity for the diagnosis of malaria were 89.68% and 98.26% respectively, compared to standard microscopy, whereas the sensitivity and specificity for falciparum malaria were 88.52% and 98.26%, and for vivax malaria: 90.77% and 100%. The CareStart™ positive predictive values were 98.26% (93.88-99.52%, 95% CI) compared to 100% (96.77-100%, 95% CI) for PCR-corrected, and the negative predictive values of 89.68% (83.15-93.87%, 95% CI) were the same in microscopy as PCR-corrected. The diagnostic accuracy of CareStart™ kit versus microscopy and PCR were 93.78% (89.99-96.19%, 95% CI) and 94.61% (90.99-96.82%, 95% CI) respectively. The likelihood of diagnostic of malaria positive was almost similar between microscopy and CareStart™ kit, with an entropy reduction of 60.0% compared to a weak likelihood of misdiagnosis of 0.10 (0.09-0.12, 95% CI), with an entropy reduction of 36.01%.

Conclusion

The accuracy of CareStart™ kit is comparable to gold standard microscopy in these areas, it is easy to perform and suitable for cross-border diagnosis and monitoring of local or imported malaria patterns by any local health staff in endemic remotes.

Keywords:
CareStart™; Diagnostic; Malaria; Microscopy; Performance; Plasmodium; Standard