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Evaluating the Performance of Locally Purchased Malaria Rapid Diagnostic Test in the Laboratory, Using Highly Characterized Quality Control Samples

Authors: OKANGBA Chika

Publication Type: Journal article

Journal: International Journal Of Research And Innovation In Applied Science

ISSN Number:

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Abstract

A total of 36 Malaria Rapid Diagnostic Tests
(MRDTs) were evaluated in the year 2007 using four highly
characterized Quality Control (QC) samples at 200p/ul and
2000p/ul dilutions to assess their performance. Twenty-three
MRDTs were not locally purchased in the open market in Lagos
but were gotten directly from the manufacturers. Malaria Rapid
Diagnostic Tests, out of the 23 MRDTs 19 of them are Histidine
rich protein based MRDTs while 4 are Plasmodium lactate
dehydrogenase based MRDTs 17 (73.9%) MRDTs of the
IMRDTs passed while 6 (26.1%) failed Quality Assurance (QA)
testing. Thirteen were locally purchased MRDTs (LPMRDTs),
only 1 (7.7%) of LPMRDTs passed, while the remaining 12
(92.3%) failed QA testing. Imported MRDTs had mean signal
strength of 1.14±0.56 at 200p/µl and 2.26±0.58 signal strength at
2000p/µl, while the LPMRDTs had a mean signal strength of
0.28±0.49 at 200p/µl and0.79 ±0.75 at 2000p/µl. In the year 2013,
quality assurance of locally purchased was repeated using 30
MRDTs (22 HRP2 based and 8 pLDH based ) which were part of
the MRDTs tested in 2007 were tested using highly characterized
QC samples. All the MRDTs tested using 200p/ul and 2000p/ul
dilutions passed QA testing (100% sensitive and specific). The
mean signal strength at 200p/ul and 2000p/ul were high. There
was no significantly difference in the signal strength and
performance of the malaria RDTs (P < 0> testing, all the MRDTs that had 100% sensitivity during the
initial QA testing were stored at different temperatures (35oC,
40oC and 45oC) for 6 months. All the MRDTs had 100%
positivity. There was a significant improvement in the
performance of the locally purchased MRDTs in the year 2013
this result shows that the implementation of MRDTs product
testing by WHO has made a great impact in the quality of
MRDTs sold in the open market in lagos, Nigeria.

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OKANGBA,C. . (2019). Evaluating the Performance of Locally Purchased Malaria Rapid Diagnostic Test in the Laboratory, Using Highly Characterized Quality Control Samples, 4 (), 28-28.

OKANGBA,C. . "Evaluating the Performance of Locally Purchased Malaria Rapid Diagnostic Test in the Laboratory, Using Highly Characterized Quality Control Samples" 4, no (), (2019): 28-28.

OKANGBA,C. and . (2019). Evaluating the Performance of Locally Purchased Malaria Rapid Diagnostic Test in the Laboratory, Using Highly Characterized Quality Control Samples, 4 (), pp28-28.

OKANGBAC, . Evaluating the Performance of Locally Purchased Malaria Rapid Diagnostic Test in the Laboratory, Using Highly Characterized Quality Control Samples. 2019, 4 ():28-28.

OKANGBA,Chika , . "Evaluating the Performance of Locally Purchased Malaria Rapid Diagnostic Test in the Laboratory, Using Highly Characterized Quality Control Samples", 4 . (2019) : 28-28.

O.Chika , "Evaluating the Performance of Locally Purchased Malaria Rapid Diagnostic Test in the Laboratory, Using Highly Characterized Quality Control Samples" vol.4, no., pp. 28-28, 2019.

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