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Corporate Authors:
Special Programme for Research and Training in Tropical Diseases. ; World Health Organization. ; Foundation for Innovative New Diagnostics. ; Centers for Disease Control and Prevention (U.S.)
Special Programme for Research and Training in Tropical Diseases. ; World Health Organization. ; Foundation for Innovative New Diagnostics. ; Centers for Disease Control and Prevention (U.S.) Less -
Description:
The RDT evaluations summarized here were performed in collaboration by WHO, TDR, FIND, the United States Centers for Disease Control and Prevention (CDC) and other partners. All companies that manufacture according to the ISO 13485:2003 quality system standard were invited to submit one to three products for evaluation in the programme. In each round of testing, products are evaluated against geographically diverse, cryopreserved Plasmodium falci- parum and P. vivax clinical samples diluted to 200 and 2000 parasites/μL and with consistently comparable concen- tration ranges of histidine-rich protein II (HRP2), Plasmodium lactate dehydrogenase (pLDH) and aldolase determined by quantitative enzyme-linked immunosorbent assay (ELISA) (Annex S1). In the first round of testing, 41 products from 21 manufacturers were evaluated against prepared blood panels of cultured P. falciparum parasites, while 29, 50, 48 and 42 products from 13, 23, 27 and 34 manufacturers were evaluated in rounds 2, 3, 4 and 5, respectively. Of these 210 products, 206 progressed to testing against panels of patient-derived P. falciparum and P. vivax parasites and a parasite-negative panel. Thermal stability was assessed after 2 months of storage at elevated temperature and humidity, and a descriptive assessment of ease of use was made. Many manufacturers have decided voluntarily to submit products to one or more rounds of testing, and, in round 5, a require- ment was instituted to resubmit products for re-evaluation within 5 years of original testing (Table S1). Of the 206 fully evaluated products, 32 have been evaluated twice, 11 have been evaluated three times and two evaluated four times in rounds 1–5. Of the 147 unique products tested in the programme, 36 detect P. falciparum alone, 101 detect and differentiate P. falciparum from non-P. falciparum malaria (either pan-specific or species-specific for P. vivax or P. vivax, ovale and malariae), 9 detect P. falciparum and non-P. falci- parum malaria without distinguishing between them, and one product was designed to detect P. vivax only. Manufacturers submitted two lots of each product for evaluation. When the same products (7) were resubmitted in subsequent rounds of testing, the second set of results replaced those from the earlier round. Thus, the performance of some tests in the results below differs from that reported in rounds 1–4.

ISBN 978 92 4 150755 4


Subjects:
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Antimalarials/therapeutic Use Diagnostic Tests, Routine Malaria/diagnosis Malaria/drug Therapy Reagent Kits, Diagnostic Sensitivity And Specificity
Document Type:
Report
Collection(s):
Stephen B. Thacker CDC Library collection
Main Document Checksum:
[+]
urn:sha256:7a19a338cc41eca78ea03056e08965af03fd1ca19a0be5c0e95380d16d390e4e
Download URL:
https://stacks.cdc.gov/view/cdc/27963/cdc_27963_DS1.pdf
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