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. 2022 Jul 6;17(7):e0270860. doi: 10.1371/journal.pone.0270860

Table 3. Summary of findings: Sensitivity and specificity.

Test Intended location Diagnostic target—as reported in studies Sample type Enrich-ment step? Reference No. Studies Study IDs Sensitivity % (95% CI) Specificity % (95% CI)
Immunologically-based tests detecting lipopolysaccharides or proteins
Artron RDT Field Antigens of V. cholerae O1 and O139 Stool No Culture 1 Matias 2017 [45] 98.6 (92.7–100) 69.1 (55.2–80.9)
Bead ELISA Laboratory Cholera toxin Stool No Culture 3 Range of point estimates 69.9–84.7 63.6–81.8
Ramamurthy 1996 [55] (mAb-based) 69.9 (57.9–79.8)1 81.8 (59–94)1
Ramamurthy 1996 [55] (pAb-based) 82.1 (71.1–89.8)1 63.6 (40.8–82)1
Ramamurthy 1993 [54] 82.9 (71.6–90.5)1 79.2 (65.5–88.7)1
Ramamurthy 1992 [53] 84.7 (72.5–92.5)1 81.3 (53.7–95)1
BengalScreen Field Lipopolysaccharide antigen of V. cholerae O139 Stool No Culture 1 Hasan 1995 [37] 95 (71.9–99.7)1 100 (75.9–100)1
Bengal DFA Field Lipopolysaccharide antigen of V. cholerae O139 Stool No Culture 1 Hasan 1995 [37] 100 (79.1–100)1 100 (75.9–100)1
Bengal SMART Field ’A’ factor of V. cholerae O139 Stool No Culture 1 Qadri 1995 [52] 97 (89.5–99.1)1 100 (95.5–100)1
Cholera Screen Field ’A’ factor of V. cholerae lipopolysaccharide O1 Stool No Culture 3 Range of point estimates 98–100 22.2–100
Colwell 1992 [29] (Guatemala) 100 (65.5–100)1 42.9 (11.8–79.8)1
Colwell 1992 [29] (Bangladesh) 98 (88–99.9)1 77.8 (57.3–90.6)1
Carillo 1994 [25] 98.8 (92.4–99.9)1 22.2 (7.4–48.1)1
Islam 1994 [39] 100 (39.58–100)1 100 (91.58–100)1
Cholkit Field Lipopolysaccharide antigen of V. cholerae O1 Stool No Culture 2 Range of point estimates 79.4–97.7 87.4–96.5
Islam 2019 [40] 79.4 (62.1–91.3) 87.4 (85.5–89.1)
Sayeed 2018 [56] 97.7 (88.4–99.9)2 96.5 (88.6–99.6)2
Lipopolysaccharide antigen of V. cholerae O1 Stool Yes Culture 1 Islam 2019 [40] 66.7 (47.2–82.7) 94.4 (91.7–96.5)
Co-agglutination test (COAT) Field Lipopolysaccharide antigens of V. cholerae O139 Stool No Culture 1 Qadri 1994 [51] 92 (84.1–96.5)1 100 (96.7–100)1
Cholera DFA Laboratory ’A’ factor of V. cholerae lipopolysaccharide O1 Stool No Culture 1 Hasan 1994a [35] 100 (82.2–100)1 100 (80.8–100)1
Cholera diagnostic kit (mAb-based dot-blot ELISA) Field V cholerae O1 antigen A Stool Yes Culture 1 Range of point estimates 95.2–100 100
Supawat 1994 [57] (patients) 100 (73.2–100)1 100 (97.6–100)1
Supawat 1994 [57] (household contacts) 95.2 (74.1–99.8)1 100 (98.8–100)1
Cholera SMART Field Antigen A of V. cholerae O1 lipopolysaccharide Stool No Culture 3 Range of point estimates 58–100 95–100
Bolaños 2004 [23] 100 (74.7–100)1 100 (71.7–100)1
Hasan 1994b [36] (Bangladesh) 95.6 (76–99.8)1 100 (80.8–100)1
Kalluri 2006 [42] (field techs) 58 (46–71) 95 (91–98)
Kalluri 2006 [42] (lab techs) 83 (75–90) 88 (82–93)
Antigen A of V. cholerae O1 lipopolysaccharide Stool No Cholera Screen 1 Hasan 1994b [36] (Mexico) 100 (90.2–100)1 100 (92.8–100)1
Crystal VC Field Lipopolysaccharide antigen of V. cholerae O1 and O139 Stool No Bacterial Culture 7 Range of point estimates 65.6–98.6 49.2–98.4
George 2014 [32] 65.6 (52.7–77.1) 91.8 (81.9–97.3)
Page 2012 [50] (clinicians) 93.8 (89.2–97.2)2 78.4 (59.6–98.7)2
Page 2012 [50] (lab techs) 93.0 (88.3–96.6)1 85.2 (69.8–99.2)1
Ley 2012 [43] 93.1 (88.7–96.2)2 49.2 (44.3–54.1)2
Mukherjee 2010 [47] 91.70 (95% CI not available) 72.90 (95% CI not available)
Islam 2019 [40] 72.2 (64.6–78.9) 77.1 (75.9–78.2)
Sayeed 2018 [56] 97.5 (87.5–99.9)2 98.4 (92.0–99.9)2
Matias 2017 [45] 98.6 (96.5–99.6) 71.1 (64.6–76.9)
Lipopolysaccharide antigen of V. cholerae O1 and O139 Stool Yes Bacterial Culture 3 Range of point estimates 75–98.9 90–98.4
George 2014 [32] 75 (62.6–85) 98.4 (91.2–100)
Bwire 2017 [24] 98.9 (94.09–99.97) 90 (55.5–99.75)
Islam 2019 [40] 68.3 (51.9–81.9); 90.8 (88.1–92.9)
Lipopolysaccharide antigen of V. cholerae O1 and O139 Stool No PCR 2 Range of point estimates 94.4–97 75–79.7
Ontweka 2016 [10] 94.4 (81.3–99.3) 79.7 (67.8–88.7)
Harris 2009 [34] 97 (88.7–99.5)1 75 (56.2–87.9)1
Lipopolysaccharide antigen of V. cholerae O1 and O139 Stool Yes PCR 2 Range of point estimates 86.1–89.3 98.9–100
Ontweka 2016 [10] 86.1 (70.5–95.3) 100 (94.4–100)
Debes 2016 [30] 89.3 (71.8–97.7)1 98.9 (97.8–99.6)1
Lipopolysaccharide antigen of V. cholerae O1 and O139 Stool No Culture or PCR 1 Range of point estimates 88.2–91.9 82.6–88.6
Page 2012 [50] (clinicians) 91.9 (87–95.4) 82.6 (71.6–90.7)
Page 2012 [50] (lab techs) 88.2 (82.6–92.4) 88.6 (78.7–94.9)
Lipopolysaccharide antigen of V. cholerae O1 and O139 Water Yes Culture 2 Range of point estimates 65.6–87 99.6–100
Rashid 2017 [1] 65.6 (55.2–75) 99.6 (99.2–99.9)
Chakraborty 2013 [28] 87 (74.9–94.3)1 100 (99–100) 1
Dot-blot ELISA Laboratory V. cholerae O1 antigen Stool No Culture 1 Chaicumpa 1995 [26] 63 (53.1–71.3)1 97 (82–99.8)1
V. cholerae O139 antigen Stool Yes Culture 1 Chaicumpa 1998 [27] 100 (89.6–100)1 99.95 (99.8–99.9)1
IP dipstick Field V. cholerae O1 lipopolysaccharide Stool No Culture 3 Range of point estimates 93–98.5 67–95.9
Wang 2006 [59] 93 (87–99) 77 (69–85)
Kalluri 2006 [42] (field techs); 93 (87–97) 67 (60–74)
Kalluri 2006 [42] (lab techs) 94 (88–98) 76 (70–82)
Nato 2003 [49] (Madagascar) 98.5 (90.7–99.9)1 95.9 (87.8–98.9)1
Nato 2003 [49] (Bangladesh) 94.2 (83.1–98.5)1 84.0 (70.3–92.4)1
V. cholerae O1 lipopolysaccharide Stool Yes Culture 2 Range of point estimates 97–97 92.4–97
Wang 2006 [59] 97 (93–100) 97 (95–100)
Bhuiyan 2003 [22] 97 (88.7–99.5)1 92.4 (82.5–97.2)1
V. cholerae O139 lipopolysaccharides Stool No Culture 1 Nato 2003 [49] (Bangladesh) 100 (95–100) 1 92.5 (82.7–97.2)1
V. cholerae O139 lipopolysaccharides Stool Yes Culture 1 Bhuiyan 2003 [22] 92.6 (74.2–98.7)1 98.1 (92.8–99.7)1
Latex agglutination test Field Lipopolysaccharide antigen of V. cholerae O1 and O139 Stool No Culture 1 Carillo 1994 [25] 100 (94.4–100)1 33 (14.4–58.8)1
Medicos dipstick Field V cholerae O1 (exact target and mechanism unknown)3 Stool No Culture 1 Range of point estimates 84–88 79–80
Kalluri 2006 [42] (field techs) 84 (77–91) 79 (73–85)
Kalluri 2006 [42] (lab techs) 88 (81–94) 80 (73–95)
Pathogen Detection Kit (PDK) Field Antigen A of V. cholerae O1 lipopolysaccharide Stool No Culture 1 Bolaños 2004 [23] 100 (71.7–100) 86 (56.2–97.5)
SD Bioline Field Antigens of V. cholerae O1 and O139 Stool No Culture or PCR 1 Mwaba 2018 [48] 90.9 (81.3–96.6) 95.2 (89.1–98.4)
Antigens of V. cholerae O1 and O139 Stool Yes Culture or PCR 1 Mwaba 2018 [48] 95.5 (87.3–99.1) 100 (96.5–100)
Antigens of V. cholerae O1 and O139 Stool No Culture 1 Matias 2017 [45] 81.1 (75.6–85.8) 92.8 (88.4–95.9)
Two-tip dipstick ELISA (sandwich ELISA) Field V. cholerae O1 and O139 antigens Stool Yes Culture 1 Tuteja 2007 [58] 100 (91.4–100)1 100 (82.2–100)1
V. cholerae O1 and O139 antigens Water Yes Culture 1 Tuteja 2007 [58] 100 (31–100) 1 100 (90.6–100)1
Vch-UPT-LF Field V. cholerae O1 antigen Water No Combination (culture or 2+ of colloidal gold assay, real time fluorescent PCR, Vch-UPT-LF) 1 Hao 2017 [33] 100 (71.7–100) 100 (94.5–100)
Vibrio cholerae O139 antigen Water No As above 1 Hao 2017 [33] 100 (19.8–100) 99 (93.4–99.9)
PCR-based tests detecting genes or nucleic acids
Multiplex PCR (with: O139-rfb primers—O139F-2, O139R-2; O1-rfb primers—O1F-2, O1R-2; cholera toxin primers—VCT1, VCT2) Laboratory V. cholerae O1 and O139 rbf-specific genes and the ctxA gene. Stool No Culture 1 Sayeed 2018 [56] 73.6 (58.5–85.7)2 97.2 (93.2–99.2) 2
V. cholerae O1 and O139 rbf-specific genes and the ctxA gene. Stool Yes Culture 1 Hoshino 1998 [38] 100 (88.6–100)1 95 (87.5–98.4)1
PCR (with primers specific to espM gene) Laboratory epsM gene of V. cholerae Water Yes Culture 1 Momtaz 2013 [46] 100 (31–100) 1 100 (98.9–100)1
PCR (with primers specific to V. cholerae O1) Laboratory Cholera Toxin gene of V. cholerae O1. Stool Yes Culture 1 Ramamurthy 1993 [54] 100 (93.5–100)1 55 (40.6–68.2)1
PCR assay (with new primers O139-1 and O139-2) Laboratory Chromosomal region of V. cholerae O139 Stool No Culture 1 Albert 1997 [21] 94 (84.7–98.1)1 100 (95.9–100)1
TaqMan Array Card (singleplex real time PCR format) Laboratory toxR gene Stool No Conventional assay 1 Liu 2013 [44] 100 (59.8–100)1 100 (93.7–100)1
toxR gene Stool No PCR Luminex 1 Liu 2013 [44] 100 (62.9–100)1 100 (95.4–100)1
Other test types: real-time cell analysis, and selective media-based tests
Cholera toxin real-time cell analysis Laboratory Cholera toxin Stool No Combination (2+ matching results among real-time PCR, VET-RPLA, and CT-RTCA) 1 Jin 2013 [41] 90 (72.3–97.4)1 97 (89.1–99.5)1
ChromID Vibrio Laboratory V. cholerae bacterial strains Stool No Combination (by Vitek 2 and/or ID 32 E biochemical strips, PCR, or comparison of ChromID Vibrio with TCBS) 1 Eddabra 2011 [31] 79 (48.8–94.3) 1 100 (75.9–100) 1
V. cholerae bacterial strains Stool Yes As above 1 Eddabra 2011 [31] 100 (73.2–100)1 100 (75.9–100)1
TCBS Laboratory V. cholerae bacterial strains Stool No As above 1 Eddabra 2011 [31] 79 (48.8–94.3)1 50 (25.5–74.5)1
V. cholerae bacterial strains Stool Yes As above 1 Eddabra 2011 [31] 100 (73.2–100)1 50 (25.5–74.5)1

1Confidence Intervals calculated from raw numbers provided in paper

2Estimate calculated using Bayesian latent class modelling

3Exact target and mechanism unknown, assumed immunologically-based