Laboratory medicine · 2019
Prospective Investigation of an Automated PCR/Nucleic Acid Microarray-Based Platform for Enteric Pathogen Testing.
Оценочное исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Beckman Amy K, Ferrieri Patricia
Аннотация
BACKGROUND: The Verigene Enteric Pathogens Test (Luminex Corporation) is a polymerase chain reaction (PCR)/nucleic acid microarray-based assay targeting 8 bacterial and viral pathogens that cause diarrhea.
OBJECTIVE: To compare traditional enteric culture methods with stool testing by Verigene EP (PCR/microarray).
METHODS: Tests were performed using PCR/microarray between February and August 2016. All specimens also underwent culture for Salmonella and Shigella; specimens that tested positive for bacterial pathogen(s) had confirmatory cultures.
RESULTS: Valid results were obtained for 99.3% of the 3795 stool specimens. Among these, 497 (13.2%) specimens tested positive for at least 1 pathogen by PCR/microarray; 45.5% of these tested positive for 1 or more bacterial pathogens. Agreement between positive bacterial PCR/microarray results and culture-based testing was 85.3%. Compared with cultures, PCR/microarray demonstrated 95.2% and 87.5% sensitivity and 99.8% and 99.8% specificity for Salmonella and Shigella, respectively.
CONCLUSIONS: The Verigene EP generated evaluable results for most stool specimens tested and demonstrated good agreement with bacterial cultures.
OBJECTIVE: To compare traditional enteric culture methods with stool testing by Verigene EP (PCR/microarray).
METHODS: Tests were performed using PCR/microarray between February and August 2016. All specimens also underwent culture for Salmonella and Shigella; specimens that tested positive for bacterial pathogen(s) had confirmatory cultures.
RESULTS: Valid results were obtained for 99.3% of the 3795 stool specimens. Among these, 497 (13.2%) specimens tested positive for at least 1 pathogen by PCR/microarray; 45.5% of these tested positive for 1 or more bacterial pathogens. Agreement between positive bacterial PCR/microarray results and culture-based testing was 85.3%. Compared with cultures, PCR/microarray demonstrated 95.2% and 87.5% sensitivity and 99.8% and 99.8% specificity for Salmonella and Shigella, respectively.
CONCLUSIONS: The Verigene EP generated evaluable results for most stool specimens tested and demonstrated good agreement with bacterial cultures.