Table 3Toxin gene detection tests compared to immunoassays

StudySensitivity (% True Positives)% False Positives (1 Minus Specificity)
Toxin Gene TestToxin Immunoassay% DifferenceToxin Gene TestToxin Immunoassay% Difference
Kvach, 201037
Eastwood, 200932
Pooled Estimate heterogeneity
GeneOhm, Becton Dickinson
96/105 (91%)
92/103 (89%)
Tox A/B II, TechLab
70/105 (67%)
100/125 (80%)
25 (11 to 39)*
9 (-3 to 21)
17 (-3 to 37)
p=0.03; I2=79%
GeneOhm, Becton Dickinson
0/295 (0%)
16/449 (3.6%)
Tox A/B II, TechLab
1/295 (0.3%)
19/475 (4.0%)
0 (-4 to 3)
0 (-2 to 1)
0 (-1 to 1)
p=0.90; I2=0%
Swindells, 2010165
Eastwood, 200932
Pooled Estimate heterogeneity
GeneOhm, Becton Dickinson
17/18 (94.4%)
92/103 (89%)
VIDAS Clostridium difficile A and B, bioMerieux
8/18 (44.4%)
100/116 (86%)
50 (17 to 83)
3 (-8 to 14)
25 (-36 to 86)
p<0.001; I2=92%
GeneOhm, Becton Dickinson
1/132 (0.8%)
16/449 (3.6%)
VIDAS Clostridium difficile A and B, bioMerieux
0/132 (0%)
2/464 (0.4%)
1 (-2 to 3) 3
(1 to 6)
2 (-1 to 5)
p=0.07; I2=70%
Eastwood, 200932GeneOhm, Becton Dickinson
92/103 (89%)
Premier Toxin A&B, Meridian
101/125 (81%)
9 (-3 to 21)GeneOhm, Becton Dickinson
16/449 (3.6%)
Premier Toxin A&B, Meridian
12/475 (2.5%)
1 (-2 to 4)
Eastwood, 200932GeneOhm, Becton Dickinson
92/103 (89%)
ImmunoCard A&B, Meridian
86/115 (75%)
15 (1 to 28)GeneOhm, Becton Dickinson
16/449 (3.6%)
ImmunoCard Toxin A&B, Meridian
2/444 (0.4%)
3 (1 to 6)
Eastwood, 200932GeneOhm, Becton Dickinson
92/103 (89%)
Tox A/B QUIK CHEK, TechLab
93/125 (74%)
15 (2 to 28)GeneOhm, Becton Dickinson
16/449 (3.6%)
Tox A/B QUIK CHEK, TechLab
3/473 (0.6%)
3 (0 to 5)
Eastwood, 200932GeneOhm, Becton Dickinson
92/103 (89%)
ProSpecT Toxin A/B, Remel
102/125 (82%)
8 (-4 to 20)GeneOhm, Becton Dickinson
16/449 (3.6%)
ProSpecT Toxin A/B, Remel
32/475 (6.7%)
-3 (-7 to 1)
Eastwood, 200932GeneOhm, Becton Dickinson
92/103 (89%)
Xpect Toxin A/B, Remel
86/117 (74%)
16 (3 to 29)GeneOhm, Becton Dickinson
16/449 (3.6%)
Xpect Toxin A/B, Remel
3/475 (0.6%)
3 (0 to 5)
Swindells 2010165GeneXpert, Cepheid
18/18 (100%)
VIDAS Clostridium difficile A and B, bioMerieux
8/18 (44.4%)
56 (25 to 86)GeneXpert, Cepheid
1/132 (0.8%)
VIDAS Clostridium difficile A and B, bioMerieux
0/132 (0%)
1 (-1 to 3)
Novak-Weekly, 201040GeneXpert, Cepheid
68/72 (94%)
Premier Toxin A&B, Meridian
42/72 (58%)
36 (20 to 53)GeneXpert, Cepheid
13/356 (3.7%)
Premier Toxin A&B, Meridian
19/360 (5.3%)
-2 (-6 to 2)
*

Values in parentheses are 99% confidence intervals for the difference between tests conservatively assuming statistical independence between the paired tests.

The p-value is a chi-square test for nonrandom variation in the differences between studies, and I2 is the proportion of the total variance in the estimated differences that reflects true variation (i.e. heterogeneity between studies).

From: Results

Cover of Effectiveness of Early Diagnosis, Prevention, and Treatment of Clostridium difficile Infection
Effectiveness of Early Diagnosis, Prevention, and Treatment of Clostridium difficile Infection [Internet].
Comparative Effectiveness Reviews, No. 31.
Butler M, Bliss D, Drekonja D, et al.

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