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Table 3

Sensitivity and specificity estimated after a comparative study of commercial PCR multiplex for each targeted gastrointestinal protist.

Technique No of samples tested No of samples and corresponding sensitivity and specificity
Overall Se (CI) Overall Sp (CI)
C. parvum/hominis
G. intestinalis
E. histolytica
D. fragilis
Blastocystis sp..
Se (CI)* Sp (CI)** Se (CI) Sp (CI) Se (CI) Sp (CI) Se (CI) Sp (CI) Se (CI) Sp (CI)
G-DiaParaTrio® (Diagenode) 184 100% (26/26) 100% (156/156) 92.5% (82.5–100) (37/40) 100% (144/144) 71.4% (42.9–100) (5/7) 100% (177/177) NA NA NA NA 93.2% (87.4–99) (68/73) 100% (477/477)
Allplex® (Seegene) 184 100% (26/26) 100% (156/156) 97.5% (92.5–100) (39/40) 100% (144/144) 85.7% (57.1–100) (6/7) 100% (177/177) 100% (4/4) 94.4% (90.6–97.2) (170/180) 95.3% (89.1–100) (61/64) 97.5% (94.2–100) (117/120) 96.5% (93.4–99.5) (136/141) 98.3% (97.4–99.2) (764/777)
Rida®gene (r-biopharm) 184 92.3% (80.8–100) (24/26) 100% (156/156) 92.5% (82.5–100) (37/40) 99.3% (97.9–100) (143/144) 100% (7/7) 100% (177/177) 25% (0–75) (1/4) 98.3% (96.1–100) (170/180) NA NA 89.6% (82.8–96.4) (69/77) 98.3% (95.5–100) (646/657)
Composite reference method*** 184 100% (26/26) 100% (156/156) 92.5% (82.5–100) (37/40) 100% (144/144) 42.9% (14.3–85.7) (3/7) 92.9% (79.4–100) (13/14) 25% (0–75) (1/4) 100% (180/180) 26.6% (15.6–37.5) (17/64) 100% (120/120) 59.6% (51.5–67.7) (84/141) 99.8% (99.5–100) (613/614)
Final parasitological diagnosis§ 26 40 7 4 64 141

Se: sensitivity, Sp: Specificity, CI: 95% confidence interval, NA: not applicable.

*

Sensitivity corresponds to the percentage of true positive results obtained for the targeted pathogen by the tested technique and was calculated as follows: Se = (number of positive results observed/overall positive results). The 95% confidence interval was estimated with a binomial law.

**

Specificity corresponds to the percentage of true negative results obtained by the tested technique and was calculated as follows: Sp = (number of negative results observed/overall negative results) */100. The 95% confidence interval was estimated with a binomial law.

***

The composite reference method was composed of a microscopic examination based on iodine-stained mount, Bailanger’s diphasic concentration method and modified Ziehl–Neelsen staining associated with E. histolytica-specific adhesion detection.

§

The final parasitological diagnosis corresponds to the combination of the composite reference method results or the PCR results obtained by a gastrointestinal multiplex PCR and the results obtained by the species-specific PCR targeted the same protists.

#

Sensitivity and specificity for C. cayetanensis detection could not be evaluated because of the lack of positive samples.

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