Quality issues with malaria rapid diagnostic test accessories and buffer packaging: findings from a 5-country private sector project in Africa

• Published in: Malaria Journal
• Main Authors: Steven A. Harvey, Sandra Incardona, Nina Martin, Cristina Lussiana, Elizabeth Streat, Stephanie Dolan, Nora Champouillon, Daniel J. Kyabayinze, Robert Mugerwa, Grace Nakanwagi, Nancy Njoki, Ratsimandisa Rova, Jane Cunningham
• Format: Article in Journal/Newspaper
• Language: English
• Published: BMC 2017
• Subjects: Malaria; Buffer Volume; Population Service International; Alcohol Swab; Supervisory Visit; Arctic medicine. Tropical medicine; RC955-962; Infectious and parasitic diseases; RC109-216; Arctic
• Online Access: https://doi.org/10.1186/s12936-017-1820-1; https://doaj.org/article/ebd70d82c2574939b4cb482cf93f8acc

Abstract Background Use of antigen-detecting malaria rapid diagnostic tests (RDTs) has increased exponentially over the last decade. WHO’s Global Malaria Programme, FIND, and other collaborators have established a quality assurance scheme to guide product selection, lot verification, transport, storage, and training procedures. Recent concerns over the quality of buffer packaging and test accessories suggest a need to include these items in product assessments. This paper describes quality problems with buffer and accessories encountered in a project promoting private sector RDT use in five African countries and suggests steps to avoid or more rapidly identify and resolve such problems. Methods Private provider complaints about RDT buffer vials and kit accessories were collected during supervisory visits, and a standard assessment process was developed. Using 100 tests drawn from six different lots produced by two manufacturers, lab technicians visually assessed alcohol swab packaging, blood transfer device (BTD) usability, and buffer appearance, then calculated mean blood volume from 10 BTD transfers and mean buffer volume from 10 individual buffer vials. WHO guided complaint reporting and follow-up with manufacturers. Results Supervisory visits confirmed user reports of dry alcohol swabs, poorly functioning BTDs, and non-uniform volumes of buffer. Lot testing revealed further evidence of quality problems, leading one manufacturer to replace buffer vials and accessories for 40,000 RDTs. In December 2014, WHO issued an Information Notice for Users regarding variable buffer volumes in single-use vials and recommended against procurement of these products until defects were addressed. Discussion Though not necessarily comprehensive or generalizable, the findings presented here highlight the need for extending quality assessment to all malaria RDT test kit contents. Defects such as those described in this paper could reduce test accuracy and increase probability of invalid, false positive, or false negative ...