Fecal Occult Blood (FOB) Rapid Test Kit (Immunochromatographic Assay)

Fecal Occult Blood(FOB) Rapid Test Kit  -- ICA2226

Warm Warning: This product is not available for US market.

[INTENDED USE]

The kit is used for in vitro qualitative detection of hemoglobin in human feces to detect GI bleeding and provide reference  for the diagnosis of GI bleeding diseases. FOB refers to a small amount of bleeding in the digestive tract, where red blood cells are destroyed by digestion, while  there is no obvious abnormal change in the appearance of the stool. It can’t be confirmed by naked eyes or microscopy. The  immunochromatography method used by this product is currently one of the most effective methods for clinical  examination of FOB. FOB can serve as an important.

FOB can serve as an important indicator for detecting GI bleeding caused by various reasons. In clinical practice, 20% of  patients with malignant tumors in the digestive tract can show positive FOB test in the early stage, while 90% in late stage  and this result will continue indefinitely. In addition, GI ulcers, dysentery, rectal polyps, hemorrhage caused by  hemorrhoids can also lead to FOB test positivity. The product can’t be used for the diagnosis of digestive tract diseases independently. A positive result only indicates the  possible presence of hemoglobin in the sample. Positive subjects should seek appropriate medical assistance timely for  further diagnosis, such as colonoscopy examination. A negative result cannot rule out FOB. If a negative subject still has  clinical symptoms in the gastrointestinal tract, medical testing should be used to confirm if necessary.

[[TEST PRINCIPLE] 

The kit is immunochromatographic and double-antibody sandwich method. During detection, the treated specimens are loaded into sample extraction tube. When the concentration of hemoglobin in  specimen is higher than the minimum detection limit, the hemoglobin will form complexes with labeled monoclonal  antibodies of hemoglobin firstly. Under chromatography, the complexes move forward along the NC membrane till  captured by pre-coated monoclonal antibody of hemoglobin in detection zone on nitrocellulose film (T) to form a red  reaction line on the detection zone, at this point the result is positive; conversely, if there is no hemoglobin or the  concentration of hemoglobin in specimen is below the minimum detection limit, no red reaction line appears in the  detection zone, at this point the result is negative. Regardless of whether the sample contains antigen or not, a red reaction  line will appear in the quality control zone (C), it is the criterion for determining if the chromatography process is normal.

【Positive】Both "C" and "T" show red lines. The lines at "T" can be dark or light in color, both indicate positive  results. 

【Negative】Red line presents at 'C', no line at 'T'. 

【Invalid】No red line presents at 'C', regardless of whether line presents at 'T', the result is invalid and you  should retest by with a new test kit.

[PERFORMANCE CHARACTERISTICS] 

1. Appearance The components of the kit are complete, and the test strip is not damaged or contaminated。 The width of strip is not less than 2.5 mm, and the liquid migration speed is not less than 10 mm/min. 

2.Coincidence Rate a. Positive reference coincidence rate: The all of the positive reference P1-P10 should have a positive result, and the  coincidence rate should be over than 90%. There should be no more than one false negative judgment result. b. Negative reference coincidence rate: The all of the negative reference N1-N10 should have a negative result, and  the coincidence rate should be over than 90%. There should be no more than one false positive judgment result. 

3.Repeatability: When using the enterprise repeatability reference material for testing, each of R1 and R2 is tested 10 times, with no  more than one false negative and one false positive determination, and the repeatability is ≥90%. 4.Limit of Detection Use the enterprise detection limit reference material L1-L4 for detection, the minimum detection limit is not higher  than 200ng/mL, L1-L3 results should be positive, L4 is not required. 

5.Inter batch difference Using 10 samples from 3 batches of products, the test kit was used to test the repeatability reference R1 of the  enterprise. The reaction results of all 3 batches should be positive and the color should be uniform. 

6.Analysis specificity The content of 500μg/mL sheep, chicken, rabbit, dog, pig and cow hemoglobin, 100μg/mL vitamin C, 2000μg/mL  horseradish peroxidase, and 7μg/mL Compound Cold and Flu Granules have no effect on the test results. 7.Hook effect: When the concentration of human hemoglobin of the samples tested was lower than 2000μg/mL, it  did not affect the test results.

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