Performance Evaluation of a Prototype Architect Antibody Assay for Babesia microti.

Autor:	Cheng K; Abbott Laboratories, Abbott Park, Illinois, USA., Coller KE; Abbott Laboratories, Abbott Park, Illinois, USA kelly.coller@abbott.com., Marohnic CC; Abbott Laboratories, Abbott Park, Illinois, USA., Pfeiffer ZA; Abbott Laboratories, Abbott Park, Illinois, USA., Fino JR; Abbott Laboratories, Abbott Park, Illinois, USA., Elsing RR; Abbott Laboratories, Abbott Park, Illinois, USA., Bergsma J; Abbott Laboratories, Abbott Park, Illinois, USA., Marcinkus MA; Abbott Laboratories, Abbott Park, Illinois, USA., Kar AK; Abbott Laboratories, Abbott Park, Illinois, USA., Gumbs OH; Abbott Laboratories, Abbott Park, Illinois, USA., Otis KS; Abbott Laboratories, Abbott Park, Illinois, USA., Fishpaugh J; Abbott Laboratories, Abbott Park, Illinois, USA., Schultz PW; Abbott Laboratories, Abbott Park, Illinois, USA., Pope MR; Abbott Laboratories, Abbott Park, Illinois, USA., Narvaez AR; Abbott Laboratories, Abbott Park, Illinois, USA., Wong SJ; The Wadsworth Center, New York State Department of Health, Albany, New York, USA.; The Department of Biomedical Sciences, The School of Public Health, The University at Albany, Albany, New York, USA., Madison-Antenucci S; The Wadsworth Center, New York State Department of Health, Albany, New York, USA.; The Department of Biomedical Sciences, The School of Public Health, The University at Albany, Albany, New York, USA., Leary TP; Abbott Laboratories, Abbott Park, Illinois, USA., Dawson GJ; Abbott Laboratories, Abbott Park, Illinois, USA.
Jazyk:	angličtina
Zdroj:	Journal of clinical microbiology [J Clin Microbiol] 2018 Jul 26; Vol. 56 (8). Date of Electronic Publication: 2018 Jul 26 (Print Publication: 2018).
DOI:	10.1128/JCM.00460-18
Abstrakt:	The tick-borne protozoan Babesia microti is responsible for more than 200 cases of transfusion-transmitted babesiosis (TTB) infection in the United States that have occurred over the last 30 years. Measures to mitigate the risk of TTB include nucleic acid testing (NAT) and B. microti antibody testing. A fully automated prototype B. microti antibody test was developed on the Architect instrument. The specificity was determined to be 99.98% in volunteer blood donors ( n = 28,740) from areas considered to have low endemicity for B. microti The sensitivity of the prototype test was studied in experimentally infected macaques; a total of 128 samples were detected as positive whereas 125 were detected as positive with an indirect fluorescent antibody (IFA) test; additionally, 83 (89.2%) of the PCR-positive samples were detected in contrast to 81 (87.1%) using an IFA test. All PCR-positive samples that tested negative in the prototype antibody test were preseroconversion period samples. Following seroconversion, periods of intermittent parasitemia occurred; 17 PCR-negative samples drawn in between PCR-positive bleed dates tested positive both by the prototype test (robust reactivity) and IFA test (marginal reactivity) prior to the administration of therapeutic drugs, indicating that the PCR test failed to detect samples from persistently infected macaques. The prototype assay detected 56 of 58 (96.6%) human subjects diagnosed with clinical babesiosis by both PCR and IFA testing. Overall, the prototype anti- Babesia assay provides a highly sensitive and specific test for the diagnosis of B. microti infection. While PCR is preferred for detection of window-period parasitemia, antibody tests detect infected subjects during periods of low-level parasitemia. (Copyright © 2018 Cheng et al.)
Databáze:	MEDLINE
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