TY - JOUR
T1 - Laboratory and field evaluation of the crystal vc-o1 cholera rapid diagnostic test
AU - Debes, Amanda K.
AU - Murt, Kelsey N.
AU - Waswa, Ethel
AU - Githinji, Gerald
AU - Umuro, Mamo
AU - Mbogori, Caroline
AU - Roskosky, Mellisa
AU - Ram, Malathi
AU - Shaffer, Allison
AU - Sack, David A.
AU - Boru, Waqo
N1 - Publisher Copyright:
© 2021 American Society of Tropical Medicine and Hygiene. All rights reserved.
PY - 2021/6
Y1 - 2021/6
N2 - Cholera is a severe acute, highly transmissible diarrheal disease which affects many low- and middleincome countries. Outbreaks of cholera are confirmed using microbiological culture, and additional cases during the outbreak are generally identified based on clinical case definitions, rather than laboratory confirmation. Many lowresource areas where cholera occurs lack the capacity to perform culture in an expeditious manner. A simple, reliable, and low-cost rapid diagnostic test (RDT) would improve identification of cases allowing rapid response to outbreaks. Several commercial RDTs are available for cholera testing with two lines to detect either serotypes O1 and O139; however, issues with sensitivity and specificity have not been optimal with these bivalent tests. Here, we report an evaluation of a new commercially available cholera dipstick test which detects only serotype O1. In both laboratory and field studies in Kenya, we demonstrate high sensitivity (97.5%), specificity (100%), and positive predictive value (100%) of this new RDT targeting only serogroup O1. This is the first field evaluation for the new Crystal VC-O1 RDT; however, with these highperformance metrics, this RDT could significantly improve cholera outbreak detection and improve surveillance for better understanding of cholera disease burden.
AB - Cholera is a severe acute, highly transmissible diarrheal disease which affects many low- and middleincome countries. Outbreaks of cholera are confirmed using microbiological culture, and additional cases during the outbreak are generally identified based on clinical case definitions, rather than laboratory confirmation. Many lowresource areas where cholera occurs lack the capacity to perform culture in an expeditious manner. A simple, reliable, and low-cost rapid diagnostic test (RDT) would improve identification of cases allowing rapid response to outbreaks. Several commercial RDTs are available for cholera testing with two lines to detect either serotypes O1 and O139; however, issues with sensitivity and specificity have not been optimal with these bivalent tests. Here, we report an evaluation of a new commercially available cholera dipstick test which detects only serotype O1. In both laboratory and field studies in Kenya, we demonstrate high sensitivity (97.5%), specificity (100%), and positive predictive value (100%) of this new RDT targeting only serogroup O1. This is the first field evaluation for the new Crystal VC-O1 RDT; however, with these highperformance metrics, this RDT could significantly improve cholera outbreak detection and improve surveillance for better understanding of cholera disease burden.
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U2 - 10.4269/ajtmh.20-1280
DO - 10.4269/ajtmh.20-1280
M3 - Article
C2 - 33819171
AN - SCOPUS:85107545067
SN - 0002-9637
VL - 104
SP - 2017
EP - 2023
JO - American Journal of Tropical Medicine and Hygiene
JF - American Journal of Tropical Medicine and Hygiene
IS - 6
ER -