An anonymised dataset produced as part of a study on initial accuracy of commonly used HIV rapid diagnostic tests (RDT) when stored in suboptimal conditions and the validity of delayed reading of OraQuick oral fluid tests. It contains HIV results for each RDT, age, sex, previous testing data and an indication of whether or not there was a change in the reading of OraQuick oral RDT over the 12 month period of re-reading. It may be used to validate results related to analysis of sensitivity and specificity of each sub-optimally-stored test kit compared with optimally stored Determine and Uni-Gold conducted in parallel

Choko, Augustine

Corbett, Elizabeth

Webb, Emily

PLoS ONE

LSHTM Data Compass

Variable Type Codes Description id numeric number Participant identifier age numeric number Participant age (years) sex categorical 1 = male 2 = female Participant sex testb4 categorical 1 = yes 2 = no Blank = not collected Ever tested for HIV before? resb4 categorical 1 = positive 2 = negative 3 = not applicable (never tested before) 4 = Not disclosed Blank = not collected Previous HIV test result detn categorical 1 = positive 0 = negative Optimally-stored Determine result deth categorical 1 = positive 0 = negative Sub-optimally-stored Determine result unign categorical 1 = positive 0 = negative Optimally-stored Uni-Gold result unigh categorical 1 = positive 0 = negative Sub-optimally-stored Uni-Gold result oqn categorical 1 = positive 0 = negative Optimally-stored OraQuick result oqh categorical 1 = positive 0 = negative Sub-optimally-stored OraQuick result golds categorical 1 = positive 0 = negative Blank = not collected on original variable Diagnostic reference standard result , given to participant as final result changed categorical 1 = yes 0 = no Blank = not collected on original variable Indicator if optimally-stored OraQuick changed over 12 months of re-reading changedh categorical 1 = yes 0 = no Indicator if sub-optimally-stored OraQuick changed over 12 months of re-reading  

Initial Accuracy of HIV Rapid Test Kits Stored in Suboptimal Conditions and Validity of Delayed Reading of Oral Fluid Tests

Name not available

 HIV Rapid Test Kits  
1 
 
Initial Accuracy of HIV Rapid Test Kits Stored in 
Suboptimal Conditions and Validity of Delayed 
Reading of Oral Fluid Tests 
Data Creators 
Choko AT, Webb EL and Corbett EL.  
Data Description 
An anonymised dataset produced as part of a study on initial accuracy of commonly used HIV rapid diagnostic tests 
(RDT) when stored in suboptimal conditions and the validity of delayed reading of OraQuick oral fluid tests. It contains 
HIV results for each RDT, age, sex, previous testing data and an indication of whether or not there was a change in the 
reading of OraQuick oral RDT over the 12 month period of re-reading. It may be used to validate results related to 
analysis of sensitivity and specificity of each sub-optimally-stored test kit compared with optimally stored Determine 
and Uni-Gold conducted in parallel. 
Methods 
This was a quality assurance study enrolling participants who presented to the HIV testing centre and ART centre of 
Ndirande Health Centre in urban Blantyre sequentially. Participants gave a blood sample and also used OraQuick oral 
swab to collect oral mucosal transudate sample. A nurse then performed HIV testing using optimally-stored (stored 
within manufacturer-recommended temperature of 2-28 degrees Celsius) RDTs: Determine 1/2, Uni-Gold (Alere, 
Waltham, USA and Uni-Gold Recombigen HIV, Trinity Biotech, Bray, Ireland); and OraQuick (OraSure Technologies,  
Bethlehem, USA) and also sub-optimally-stored RDTs (pre-incubated at 37 degrees Celsius for 28 days). The diagnostic 
reference standard was Determine and Uni-Gold conducted in parallel with a repeat of all optimally-stored RDTs in 
case of discordance. Each sub-optimally-stored RDT was then compared to this reference standard in order to compute 
sensitivity and sensitivity a measure of initial accuracy. All used optimally-stored and sub-optimally-stored OraQuick 
oral RDTs were sent to the laboratory located at the College of Medicine in Blantyre for immediate and subsequent 
monthly re-reading up to 12 months after use in order to assess stability of the visual read over time.   
Spatial Coverage 
Blantyre, Malawi. 
Temporal Coverage 
Data collected between 14th January 2012 and 30th April 2013. 
Quality Controls 
All oral rapid diagnostic tests were read by two independent laboratory technicians. 
Species: 
Human population 
Privacy: 
No individual participant identifiers were collected as part of this study and all oral RDTs were given a numerical 
identifier which was used throughout the 12 month re-reading period.  
Ethics 
Ethical approval was obtained from the College of Medicine Ethics Review Committee, University of Malawi 
(Approval number: P.03/12/1186). All participants provided written (or witnessed thumbprint) informed consent.   
 HIV Rapid Test Kits  
2 
 
Keywords 
HIV; diagnosis; rapid diagnostic tests; near-patient tests; diagnostic accuracy 
Language of written material 
English 
Additional Information 
Data collection tools used in the study can be provided upon request (Augustine.Choko@lshtm.ac.uk). 
Project 
Part of the parent project titled: Intensified HIV/TB prevention linking home-based HIV testing, including the option 
of self-testing, with HIV care:  a cluster-randomised trial in Blantyre, Malawi (ISRCTN02004005). 
Funder/Sponsor 
Wellcome Trust, UK. 
Grant Number 
WT091769 
Associated Roles 
Role Forename Surname Faculty / Dept Institution 
Project Leader, Data 
Creator & Contact 
Person 
Augustine Choko Epidemiology & Population Health 
> Infectious Disease Epidemiology 
London School of Hygiene 
& Tropical Medicine 
Data Creator Emily Webb Epidemiology & Population Health 
> Infectious Disease Epidemiology 
London School of Hygiene 
& Tropical Medicine 
Researcher, Rights 
holder 
Elizabeth Corbett Infectious & Tropical Diseases > 
Clinical Research 
London School of Hygiene 
& Tropical Medicine 
 
File Description 
Title Filename File type Description 
Rapid diagnostic tests 
accuracy 
rdt_accuracy.txt Tab delimited Demographic, HIV results and 
indicator of change of result from 
oral RDT 
Data dictionary data_dictionary_rdt_Tab.txt 
 
data_dictionary_rdt_PDF.pdf 
Tab delimited 
 
Adobe PDF/A 
Variable name, data type and 
description, as well as code 
meanings. 
User Guide UserGuide.pdf Adobe PDF/A This document 
 
 
 


http://datacompass.lshtm.ac.uk/214/22/data_dictionary_rdt_TAB.txt

Initial Accuracy of HIV Rapid Test Kits Stored in Suboptimal Conditions and Validity of Delayed Reading of Oral Fluid Tests

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