Hangzhou Aichek Medical Technology Co.,Ltd

Hangzhou Aichek Medical Technology Co.,Ltd

Manufacturer from China
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98.5% One Step FOB Rapid Test Cassette Feces Tumor Maker Test

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Hangzhou Aichek Medical Technology Co.,Ltd
City:hangzhou
Province/State:zhejiang
Country/Region:china
Contact Person:MrEdward YU
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98.5% One Step FOB Rapid Test Cassette Feces Tumor Maker Test

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Brand Name :Aichek
Model Number :FOB-A01
Certification :CE
Place of Origin :China
MOQ :5000 Test
Price :negotiable
Payment Terms :T/T
Supply Ability :negotiable
Packaging Details :40box/carton
Storage :2℃-30℃
Sample Type :Feces
User :Professional
Accuracy :98.5% (97.5% - 99.2%)
Certificate :CE ISO 13485
OEM :OEM customized packing avaliable
Formats :25T/box 1T/box
After-sales Service :Available
Key words :Tumor maker FOB Rapid One Step Test with CE certificate Test Device
Combo Device :Any 2 To 12 Of The Products Can Be Integrated Into A Combo Cassette
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Tumor maker FOB Rapid One Step Test with CE certificate Test Device

Product Name

FOB Rapid One Step Test

Formats Strip(3mm)Device(4mm)
Place of Origen China
Specimen Feces
Read Time 15 minutes
Shelf life 2 years
Package 25 device/box or 50 strip/Box
Storage 2℃-30℃

For professional in vitro diagnostic use only.

INTENDED USE

The FOB Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in feces.

Accuracy

The FOB Rapid Test has been compared with another leading commercial rapid test using clinical specimens.
Method Other Rapid Test Total Results

FOB Rapid

Test

Results Positive Negative
Positive 183 4 187
Negative 11 802 813
Total Results 194 806 1000

Relative Sensitivity:94.3% (90.1% - 97.1%)*

Relative Specificity: 99.5% (98.7% - 99.9%)*

Relative Accuracy: 98.5% (97.5% - 99.2%)*

* 95% Confidence Intervals

SUMMARY

Many diseases can cause hidden blood in the stool. In the early stages, gastrointestinal problems such as colon cancer, ulcers, polyps, colitis, diverticulitis, and fissures may not show any visible symptoms, only occult blood. Traditional guaiac-based method lacks sensitivity and specificity, and has diet-restrictions prior to testing.1,2

The FOB Rapid Test is a rapid test to qualitatively detect low levels of fecal occult blood in feces. The test uses double antibody sandwich assay to selectively detect hemoglobin/g feces. In addition, unlike the guaiac assays, the accuracy of the test is not affected by the diet of the patients.

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