Catalog No.No. Tests/KitKit name

714-0196 TestsCoproELISATM Blastocystis

724-0196 TestsCoproELISATM Giardia

734-0196 TestsCoproELISATM Cryptosporidium

744-0196 TestsCoproELISATM Giardia/Cryptosporidium

4121720 TestsCoproStripTM Giardia

4121820 TestsCoproStripTM Cryptosporidium

4121920 TestsCoproStripTM Giardia/Cryptosporidium

754-0196 TestsCoproELISA™ Entamoeba

774-0196 TestsCoproELISA™ H. pylori

784-0196 TestsCoproELISA™ C. diff GDH

794-0196 TestsCoproELISA™ C. diff Tox A/B

Commercial ELISA (Reference)

CoproELISATM

C. difficile GDH Positive Negative

Positive 29 1

Negative 1 25Sensitivity: 96.7% Specificity: 96.2% Accuracy: 100% PPV: 96.7% NPV: 96.2%

Commercial ELISA (Reference)

CoproELISATM

C. difficile tox A/B Positive Negative

Positive 9 1

Negative 0 46Sensitivity: 100% Specificity: 97.9% Accuracy: 100% PPV: 90% NPV: 100%

Commercial ELISA (Reference)

CoproELISATM Giardia Positive Negative

Positive 50 1

Negative 2 27

Sensitivity: 96% Specificity: 96 % Accuracy: 96%

In one study performed in Nicaragua, a total of 80 pre-defined stool specimens (microscopically-confirmed) were evaluated by CoproELISATM Giardia test for presence of Giardia antigens. Results were compared with a commercial reference ELISA kit.

Commercial ELISA (Reference)

CoproELISATM

Giardia /Cryptosporidium

Positive Negative

Positive 100 0

Negative 8 65Sensitivity: 93% Specificity: 100% Accuracy: 95% PPV: 100% NPV: 89%

In a study performed at a reference laboratory in the US, a total of 173 formalin- or SAF-fixed stool samples were tested by the CoproELISATM Giardia/Cryptosporidium test. Results were compared with a commercial reference EIA kit. Commercial ELISA (Reference)

CoproELISATM

Cryptosporidium Positive Negative

Positive 60 0

Negative 0 60Sensitivity: 100% Specificity: 100% Accuracy: 100% PPV: 100% NPV: 100%

In a study performed at a reference laboratory in the USA, a total of 120 pre-defined stool specimens (formalin or SAF-fixed) were evaluated by the CoproELISATM Cryptosporidium test. Microscopy, as well as an FDA-cleared commercial ELISA test was used as a reference

Culture (Reference)

CoproELISATM Blastocystis Positive Negative

Positive 67 14

Negative 6 92

Sensitivity: 83% Specificity: 94% Accuracy: 89% PPV: 92% NPV: 87%

In a study performed at two laboratories in Turkey and Israel, a total of 179 fresh, formalin- or SAF-fixed stool samples were tested by the CoproELISATM Blastocystis test. The presence of gastrointestinal parasites in these specimens was pre-determined by microscopic examination and culture.

Competitor ELISA (Reference)

CoproELISATM Entamoeba Positive Negative

Positive 40 2

Negative 0 42

Sensitivity: 100% Specificity: 95.4% Accuracy: 97.5% PPV: 95% NPV: 100%

In a study performed in Israel a total of 84 pre-defined stool specimens (by microscopy) were evaluated by CoproELISATM Entamoeba. The results shown below were compared with a commercial reference ELISA kit.