WHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: SD Bioline Malaria Ag P.f Number: PQDx Abstract

Transcription

1 WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: SD Bioline Malaria Ag P.f Number: PQDx Abstract SD BIOLINE Malaria Ag P.f with product codes 1 05FK50 and 05FK53, manufactured by Standard Diagnostics, Inc., was accepted for the WHO list of prequalified diagnostics and was listed on 06 December SD BIOLINE Malaria Ag P.f is a one step, rapid, qualitative test for the detection of HRP-II (Histidine rich protein II) specific to Plasmodium falciparum in human blood samples. The kit is intended for the detection of malaria infection in human blood samples. It is intended for professional use only. The test is an initial screening test, and reactive samples should be confirmed by a supplementary assay such as microscopic examination of thin blood smear. The SD BIOLINE Malaria Ag P.f cassette contains a membrane strip which is pre-coated with a monoclonal antibody. The test line is pre-coated with a monoclonal antibody specific to the HRP-II antigen of Plasmodium falciparum. The test utilized the principle of immunochromatography. As the sample flows through the membrane after the addition of the assay diluent, the coloured colloidal gold conjugates of anti-hrp-ii move to the test line region where they are immobilized by the monoclonal anti-hrp-ii antibodies coated on the membrane. This leads to the formation of a red-purple coloured band which indicates a positive result. The absence of a coloured band in the test region indicates a negative test result. The cassette has a control line which should always appear if the test procedure is performed properly and the test reagents and control line are working. The test kit contains: test device individually foil pouched with a desiccant 1 assay diluent instructions for use disposable sample applicator (5µL) Storage: The test kit should be stored at 1-40 C. 1 05FK50: 25 tests/kit 05FK53: 1 test/kit Page 1 of 12

2 Shelf-life: 24 months SD BIOLINE Malaria Ag P.f was accepted for the WHO list of prequalified diagnostics on the basis of data submitted and publicly available information. Summary of prequalification status for SD BIOLINE Malaria Ag P.f Initial acceptance Date Outcome Status on PQ list 06 December 2010 listed Dossier assessment 02 December 2010 MR Inspection status 01 December 2010 MR Laboratory evaluation 25 April 2009 MR MR: Meets Requirements NA: Not Applicable Page 2 of 12

3 Background information In 2008, Standard Diagnostics, Inc. submitted an application for prequalification of SD BIOLINE Malaria Ag P.f. Based on the results of the WHO product testing of malaria RDTs Round 1, SD BIOLINE Malaria Ag P.f was given priority for prequalification. Product dossier assessment In 2010, Standard Diagnostics, Inc. submitted a product dossier for SD BIOLINE Malaria Ag P.f as per the Instructions for compilation of a product dossier (PQDx_018 v1). The information submitted in the product dossier was reviewed by WHO staff and external experts (assessors) appointed by WHO in accordance with the internal report on the screening and assessment of a product dossier (PQDx_009 v2). Based on the product dossier screening and assessment findings, a recommendation was made to accept the product dossier for SD BIOLINE Malaria Ag P.f for prequalification. Commitments for prequalification: The manufacturer committed to amend and submit additional documentation on the following issues: 1. the risk analysis and control summary reflecting use in resource-limited settings 2. analytical and stability studies 3. revised labels and instructions for use. Manufacturing site inspection A comprehensive inspection was performed at the site of manufacture (Giheung-ku, Republic of South Korea) of the SD BIOLINE Malaria Ag P.f test in September/October 2010 as per the Information for manufacturers on prequalification inspection procedures for the sites of manufacture of diagnostics (PQDx_014 v1). The inspection found that the manufacturer had an acceptable quality management system and good manufacturing practices in place that ensured the consistent manufacture of a product of good quality. The manufacturer's responses to the nonconformities found at the time of the inspection were accepted 1 December Commitments for prequalification: 1. documented evidence to support the responses to the nonconformities will be provided as processes addressing the nonconformities are further embedded 2. analysis by the manufacturer of the nonconformities will be further expanded to include related quality management issues. Page 3 of 12

4 Laboratory evaluation The first round of WHO product testing of RDTs for malaria antigen detection was completed in November The product was evaluated against prepared blood panels of cultured Plasmodium falciparum parasites, patient-derived Plasmodium falciparum parasites and a parasite-negative panel. Thermal stability was assessed after 2 months of storage at elevated temperature and humidity, and a descriptive ease of use assessment was recorded. Based on the demonstrated P. falciparum detection score, false positive rate and invalid rate, SD BIOLINE Malaria Ag P.f meets the current laboratory evaluation requirements for prequalification. 2 ISBM accessible at the following website: 3A129A6365C4/0/OMSFINDRapportMalaria v25.pdf Page 4 of 12

5 Labelling 1. Labels 2. Instructions for use Page 5 of 12

6 1. Labels 1.1 Label for 1-device foil pouch Front view Back view Page 6 of 12

7 1.2 Label for assay diluent (05FK50: 25 tests/kit 5 ml / dropping bottle x 1) 1.3 Label for package box (05FK50: 25 tests/kit) Back view Top view Side view 1 Side view 2 Front view Page 7 of 12

8 Top view Front view Page 8 of 12

9 Back view Side view 1 Side view 2 Page 9 of 12

10 1.4 Label for package box (05FK53 : 1 test/kit) Back view Side view 1 Top view Front view Side view 2 Top view Page 10 of 12

11 Front view Back view Side view 1 Side view 2 Page 11 of 12

12 PQDx WHO PQDx PR 2. Instructions for use [05FK50] Page 12 of 12 12/2010, version 1.0