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Malar J. 2015 Feb 19;14:85. doi: 10.1186/s12936-015-0597-3.

Quality assurance of malaria rapid diagnostic tests used for routine patient care in rural Tanzania: microscopy versus real-time polymerase chain reaction.

Author information

1
Health System Sciences, Ifakara Health Institute, PO Box 78373, Dar es Salaam, Tanzania. imasanja@ihi.or.tz.
2
Malaria Branch, Centers for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA. mmcmorrow@cdc.gov.
3
US Public Health Services, Rockville, Maryland, USA. mmcmorrow@cdc.gov.
4
Health System Sciences, Ifakara Health Institute, PO Box 78373, Dar es Salaam, Tanzania. mmaganga@ihi.or.tz.
5
Health System Sciences, Ifakara Health Institute, PO Box 78373, Dar es Salaam, Tanzania. dsumari@ihi.or.tz.
6
Malaria Branch, Centers for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA. vudhayakumar@cdc.gov.
7
Malaria Branch, Centers for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA. pgm9@cdc.gov.
8
US President Malaria Initiative (PMI), Dar es Salaam, United Republic of Tanzania. pgm9@cdc.gov.
9
Malaria Branch, Centers for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA. spkachur@cdc.gov.
10
US Public Health Services, Rockville, Maryland, USA. spkachur@cdc.gov.
11
Malaria Branch, Centers for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA. nlucchi@cdc.gov.

Abstract

BACKGROUND:

The World Health Organization (WHO) recommends parasitologic confirmation of suspected malaria cases before treatment. Due to the limited availability of quality microscopy services, this recommendation has become scalable following increased use of antigen-detecting malaria rapid diagnostic tests (RDTs) in many malaria-endemic countries. This study was carried out to monitor quality of RDT performance in selected health facilities using two quality assurance (QA) methods: reference microscopy and detection of parasite DNA by real-time quantitative polymerase chain reaction (qPCR) on dried blood spots (DBS).

METHODS:

Blood samples for QA were collected from patients undergoing RDT for diagnostic confirmation of malaria during two to three consecutive days per month in 12 health facilities in rural Tanzania. Stained blood smears (BS) were first examined at the district hospitals (BS1) and then at a reference laboratory (BS2). Discordant BS1 and BS2 results prompted a third examination. Molecular analysis was carried out at the Ifakara Health Institute laboratory in Bagamoyo.

RESULTS:

Malaria RDTs had a higher positivity rate (6.5%) than qPCR (4.2%) or microscopy (2.9% for BS1 and 2.5% for BS2). Poor correlation was observed between RDT and BS results: BS1 (K = 0.5), BS2 (K = 0.43) and qPCR (K = 0.45), challenging the utility of these tests for RDT QA. In addition, many challenges related to qPCR processing were recorded and long delays in obtaining QA test results for both microscopy and qPCR.

CONCLUSIONS:

Overall there was limited agreement among the three diagnostic approaches and neither microscopy nor qPCR appear to be good QA options for RDTs under field conditions.

PMID:
25889613
PMCID:
PMC4337228
DOI:
10.1186/s12936-015-0597-3
[Indexed for MEDLINE]
Free PMC Article

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