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A new interesting article has been published in J Clin Microbiol. 2019 Nov 22; 57(12). pii: e01217-19. doi: 10.1128/JCM.01217-19. Print 2019 Dec. and titled:

Chagas Disease Serological Test Performance in U.S. Blood Donor Specimens.

Authors of this article are:

Whitman JD, Bulman CA, Gunderson EL, Irish AM, Townsend RL, Stramer SL, Sakanari JA, Bern C.

A summary of the article is shown below:

Chagas disease affects an estimated 300,000 individuals in the United States. Diagnosis in the chronic phase requires positive results from two different IgG serological tests. Three enzyme-linked immunosorbent assays (ELISAs) (Hemagen, Ortho, and Wiener) and one rapid test (InBios) are FDA cleared, but comparative data in U.S. populations are sparse. We evaluated 500 seropositive and 300 seronegative blood donor plasma samples. Country of birth was known for 255 seropositive specimens, which were grouped into regions as follows: Mexico (n = 94), Central America (n = 88), and South America (n = 73). Specimens were tested by the four FDA-cleared IgG serological assays. Test performance was evaluated by two comparators and latent class analysis. InBios had the highest sensitivity (97.4% to 99.3%) but the lowest specificity (87.5% to 92.3%). Hemagen had the lowest sensitivity (88.0% to 92.0%) but high specificity (99.0% to 100.0%). The level of sensitivity was intermediate for Ortho (92.4% to 96.5%) and Wiener (94.0% to 97.1%); both had high specificity (98.8% to 100.0% and 96.7% to 99.3%, respectively). The levels of antibody reactivity and clinical sensitivity were lowest in donors from Mexico, intermediate in those from Central America, and highest in those from South America. Our findings provide an initial evidence base to improve laboratory diagnosis of Chagas disease in the United States. The best current testing algorithm would employ a high-sensitivity screening test followed by a high-specificity confirmatory test.Copyright © 2019 Whitman et al.

Check out the article’s website on Pubmed for more information:

This article is a good source of information and a good way to become familiar with topics such as: Chagas disease; Trypanosoma cruzi ; United States; blood donors; diagnostics; serology.

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