An evaluation of the performance and usage of ICT Pf malaria rapid diagnostic test, in the Limopo South Africa

Aim: This thesis aimed to evaluate the performance and usage of ICT Pf Malaria Rapid Diagnostic Test (MRDT), in an operational setting in the Limpopo Province, South Africa. Methods: Four studies were conducted to: assess factors affecting MRDT use (exploratory study- conducted as part of formative work); determine ICT Pf accuracy (cross-sectional study amongst 405 patients with prospective observational cohort component for follow-up); determine the performance of MRDT end-users (crosssectional observational study) and assess the suitability of using positive control antigen wells (PCWs) for routine quality control. Results: Key informants reported that MRDT accuracy, end-user proficiency and MRDT quality affect MRDT use and impact. The accuracy study found that sensitivity, specificity, positive and negative predictive values of ICT Pf test were 99.48% (99% Cl; 96.17-100.00%), 96.26% (99% Cl; 94.7-100%) 98.48 (99% Cl 98.41 -100.00%) and 96.26% (99% Cl 91.53-98.79%) respectively. Febrile patients with 'sweating' were 5 times more likely to be ICT Pf positive than those without sweating. Among the 68 patients who returned for day-seven follow up 23 (33%) were ICT Pf positive; however all were microscopy-negative. End-user proficiency: of the 15 recommended steps for MRDT use, 50% of end-users performed 11 or more steps correctly; 50% of end-users interpreted 90% of pre-prepared tests correctly. The false negative interpretation rate was 15%. The quality control study revealed that diluting PCWs with MRDT-negative blood gave better signals than diluting with citrate buffer. PCWs maintain signal strength when stored up to 30 days at 25°C at rural health clinics. Conclusions: Although ICT Pf MRDT can be used for malaria diagnosis in Limpopo, test sensitivity at low level parasitaemias in field settings need to be established. The ICT Pf test should not be used for assessing cure post-treatment. End-user proficiency needs improvement. PCWs can be used to monitor MRDT quality at PHC level.