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Visualine II® Dual Occult Blood FaecoCheck Test

(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 3838/0 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.

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