(New combination device is for the immunoassay and chemical test)
Patent and Pending
Clinical Data:
The evaluation for dual Occult Blood FaecoCheck test、OC-Hemodia Latex kit and O-Toluidine chemical test
* Use procedure B for FaecoCheck test.
Table 1.
Case Number |
O-toluidine (Chemical) ( +/- ) |
OC-Hemodia (Latex kit) ( +/- ) |
FaecoCheck (Chemical) ( +/- ) |
FaecoCheck (Immunoassay) ( +/- ) |
|
Negative cases | 38 | 38/0 | 0/38 | 28/10 | 0/38 |
Positive cases | 6 | 6/0 | 5/1 | 6/0 | 6/0 |
Total cases | 44 | 44 | 44 | 44 | 44 |
44 clinical stool samples were evaluated by O-Toluidine、OC-Hemodia and FaecoCheck test. Of the 44 samples, 5 were determined positive and 39 were determined negative by the OC-Hemodia method; 6 were determined as positive and 38 were determined as negative by FaecoCheck (immunoassay) method; 34 were determined as positive and 10 were determined as negative by FaecoCheck (chemical assay) method; all of 44 were determined as positive by O-toluidine method. Six positives were proved that is including colorectal cancer 1 case、malignant gastrointestinal tumor 1 case、duodenal ulcer 2 cases、acute gastritis 1 case and acute salmonella infected 1 case. The FaecoCheck test correctly identified 100 % of these positive samples and 100 % of these negative samples. It may be liquid faces' samples to occur 1 false negative from OC-Hemodia. All of 6 positive cases were determined positive by FaecoCheck (chemical assay) method.
Table 2. Negative Control Group
+ | - | Total | |
O-Toluidine | 0 | 133 | 133 |
FaecoCheck (Immunoassay) | 0 | 133 | 133 |
FaecoCheck (Chemical test) | 0 | 133 | 133 |
O-Toluidine and FaecoCheck test evaluated 133 negative control samples. All Of the samples were determined as negative by both systems
Table 3. Suspicious Group
+ | - | Total | |
O-Toluidine | 305 | 0 | 305 |
FaecoCheck (Immunoassay) | 55 | 250 | 305 |
305 cases were determined as positive by O-Toluidine. 55 were determined as positive and 250 were determined as negative by FaecoCheck (Immunoassay). We found that O-Toluidine has very high false positive rate.