Specifications
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 uncut sheet
Combo Device :
Any 2 To 12 Of The Products Can Be Integrated Into A Combo Cassette
Description

Tumor maker FOB Rapid One Step Test with CE certificate uncut sheet

Product Name

FOB Rapid One Step Test

Formats Strip(3mm)Device(4mm) uncut sheet
Place of Origen China
Specimen Feces
Read Time 15 minutes
Shelf life 2 years
Package uncut sheet
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.

PRINCIPLE

The FOB Rapid Test is a qualitative, lateral flow immunoassay for the detection of human occult blood in feces. The membrane is pre-coated with anti-hemoglobin antibody on the test line region of the strip. During testing, the specimen reacts with the particle coated with anti-hemoglobin antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-hemoglobin antibody on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that the proper volume of specimen has been added and membrane wicking has occurred.

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

Specificity

The FOB Rapid Test is specific to human hemoglobin. Specimen containing the following substances at the standard concentrations were tested on both positive and negative controls with no effect on test results.

Substances

Concentrations (Diluted

with the extraction buffer)

Bovine hemoglobin 1 mg/mL
Chicken hemoglobin 1 mg/mL
Pork hemoglobin 1 mg/mL
Goat hemoglobin 1 mg/mL
Horse hemoglobin 1 mg/mL
Rabbit hemoglobin 1 mg/mL
Turkey hemoglobin 1 mg/mL

SUMMARY

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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FOB Rapid Test Uncut Sheet Rtk Self Test 3mm Strip 4mm Device

Ask Latest Price
Brand Name :
Aichek
Model Number :
FOB-A01
Certification :
CE
Place of Origin :
China
MOQ :
5000 Test
Price :
negotiable
Contact Supplier
FOB Rapid Test Uncut Sheet Rtk Self Test 3mm Strip 4mm Device

Hangzhou Aichek Medical Technology Co.,Ltd

Active Member
4 Years
zhejiang, hangzhou
Since 2012
Business Type :
Manufacturer
Total Annual :
500000-1000000
Employee Number :
150~200
Certification Level :
Active Member
Contact Supplier
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