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- Title
Performance of an ultra-sensitive <italic>Plasmodium falciparum</italic> HRP2-based rapid diagnostic test with recombinant HRP2, culture parasites, and archived whole blood samples.
- Authors
Das, Smita; Peck, Roger B.; Barney, Rebecca; Jang, Ihn Kyung; Kahn, Maria; Zhu, Meilin; Domingo, Gonzalo J.
- Abstract
Background: As malaria endemic countries shift from control to elimination, the proportion of low density <italic>Plasmodium falciparum</italic> infections increases. Current field diagnostic tools, such as microscopy and rapid diagnostic tests (RDT), with detection limits of approximately 100–200 parasites/µL (p/µL) and 800–1000 pg/mL histidine-rich protein 2 (HRP2), respectively, are unable to detect these infections. A novel ultra-sensitive HRP2-based Alere™ Malaria Ag P.f RDT (uRDT) was evaluated in laboratory conditions to define the test’s performance against recombinant HRP2 and native cultured parasites. Results: The uRDT detected dilutions of <italic>P. falciparum</italic> recombinant GST-W2 and FliS-W2, as well as cultured W2 and ITG, diluted in whole blood down to 10–40 pg/mL HRP2, depending on the protein tested. uRDT specificity was 100% against 123 archived frozen whole blood samples. Rapid test cross-reactivity with HRP3 was investigated using <italic>pfhrp2</italic> gene deletion strains D10 and Dd2, <italic>pfhrp3</italic> gene deletion strain HB3, and controls <italic>pfhrp2</italic> and <italic>pfhrp3</italic> double deletion strain 3BD5 and <italic>pfhrp2</italic> and <italic>pfhrp3</italic> competent strain ITG. The commercial Standard Diagnostics, Inc. BIOLINE Malaria Ag P.f RDT (SD-RDT) and uRDT detected <italic>pfhrp2</italic> positive strains down to 49 and 3.13 p/µL, respectively. The <italic>pfhrp2</italic> deletion strains were detected down to 98 p/µL by both tests. Conclusion: The performance of the uRDT was variable depending on the protein, but overall showed a greater than 10-fold improvement over the SD-RDT. The uRDT also exhibited excellent specificity and showed the same cross-reactivity with HRP3 as the SD-RDT. Together, the results support the uRDT as a more sensitive HRP2 test that could be a potentially effective tool in elimination campaigns. Further clinical evaluations for this purpose are merited.
- Subjects
PLASMODIUM falciparum; HISTIDINE; RECOMBINANT proteins; MALARIA; DELETION mutation; DIAGNOSIS
- Publication
Malaria Journal, 2018, Vol 17, Issue 1, p1
- ISSN
1475-2875
- Publication type
Article
- DOI
10.1186/s12936-018-2268-7