One-Step Fecal Occult Blood (FOB) Diagnostic Kit (immuno/chemistry)

Main Features

♦ High Sensitivity: > 95.7%

♦ Specificity: > 99.2%

♦ Simple: No Instrument Required

♦ Convenient: Room Temperature Storage, Built-In Control line

♦ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes

♦ Certified by Authoritative Certification System and Standards

♦ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

Intended Use

The One-Step Fecal Occult Blood (FOB) Diagnostic Kit is a qualitative detection of human occult blood in feces for self-testing.

Sample Collection and Preparation

☀ Collect stool sample by using the sample collection device provided.

☀ Unscrew the top of the sample collection device, take out the sample collection stick, and collect the sample by dipping the stick into 3 different places of the stool sample.

☀ Put the sample collection stick back in the sample collection device and screw together tightly.

☀ If the sample cannot be tested on the day of collection, store the stool sample at 4°C. Bring the specimen to room temperature before testing.

Assay Procedure

☀ Remove the test device from foil pouch by tearing along the notch.

☀ Specimen collection. Please see also SPECIMEN COLLECTION

☀ Shake the sample collection device several times.

☀ Holding the sample collection device upright, carefully screw off the cap of collection device.

☀ Squeeze 2-3 drops of the sample solution on the test sample pad.

☀ Read the Chemical Method result through the sample pad in 1 minute and read the Immune Colloidal Method result through the result window in 5 minutes.

☀ Get the final result according to the synthetically.

Interpretation of Results

Interpretation of Immune Collodial Method

Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).

Negative: Only one colored band appears on the control region (C). No colored band in the test region (T).

Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test device.

Interpretation of Chemical Method

Positive: The color of the sample pad changes from orange to yellow-green or dark green in 1 minute after adding the sample.

Negative: There is no color change of the sample pad in 1 minute after adding the sample.

Invalid: If the color mixed, the test should be repeated using a new test device.

The final interpretation

☀ If both the Immune Colloidal Method and Chemical Method show positive, the final result is positive which indicates bleeding in specimen.

☀ If the Immune Colloidal Method shows positive while Chemical Method shows negative, this indicates occult bleeding. The concentration of hemoglobin in the sample is much lower. The final result is also positive.

☀ If the Immune Colloidal Method shows negative while Chemical Method shows positive, this probably because the high concentration of hemoglobin causing antigen excess, and have hook effect. It is suggested that dilute the sample 100 times and retest, if Immune Colloidal Method shows positive, this indicates the enteron begin to bleed profusely; if Immune Colloidal Method still shows negative, this indicates some substances interfered, the result should be negative.

☀ If both the Immune Colloidal Method and Chemical Method show negative ,the final result is nagative.

☀ If any one of Immune Colloidal Method and Chemical Method shows invalid, the test result is invalid, please retest with a new one.

Storage

The kits should be stored at temperature 4-30°C the sealed pouch for the duration of the shelf life (24months).