High Accuracy Tumor Mark FOB Rapid Test Strip, for detecting Fecal Occult Blood in Feces, gold colloidal method

Product Name: One Step FOB Rapid Diagnostic Test Strip / Fecal Occult Blood Rapid Diagnostic Test Strip

INTENDED USE:

The FOB Rapid Test Dipstick (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Human Occult Blood in feces.

TEST PRINCIPLE:

The FOB Rapid Test Dipstick (Feces) is a qualitative, lateral flow immunoassay for the detection of Human Occult Blood in feces. The membrane is precoated with anti-hemoglobin antibody on the test line region of the test. 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 line 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.

SPECIMEN COLLECTION AND STORAGE

1. Collect stool specimen by using the sample collection tube provided.

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

3. Replace the stick in the sample collection tube and screw tightly.

If the specimen cannot be tested on the day of collection, store the stool specimen at 2-8℃. Bring the specimen to room temperature before testing.

TEST PROCEDURE

1. To collect fecal specimens: Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen collection container to obtain maximum antigens (if present). Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8℃ if not tested within 6 hours. For long term storage, specimens should be kept below -20℃.

2. To process fecal specimens:

For Solid Specimens:

Unscrew the cap of the specimen collection tube,then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.

For Liquid Specimens:

Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops (approximately 80 μL) into the specimen collection tube containing the extraction buffer.

3. Bring the pouch to room temperature before opening it. Remove the test dipstick from the foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.

4. Fix the reaction tube, hold the specimen collection tube upright and break off the tip of the specimen collection tube. Invert the specimen collection tube and transfer 8-10 full drops of the extracted specimen (approx. 500μL) to the reaction tube, then with arrows pointing toward the exaction buffer, immerse the dipstick and start the timer. Do not immerse the dipstick past the maximum line. See illustration below.

5. Read results at 5 minutes. Do not read results after 10 minutes.

INTERPRETATION OF RESULTS

Positive: Two colored lines appears in the result window, one in the test region and another one in the control region. This indicates a positive result no matter the test line is stronger or weaker than the control line.

Negative: Only the control line appears in the result window. This indicates a negative test result.

Invalid: If the control line does not appear, the test results are invalid regardless of the presence or absence of the test line.

PERFORMANCE CHARACTERS:

The FOB Rapid Test Dipstick (Feces) has been compared with another leading commercial rapid test using clinical specimens.

Relative sensitivity: 95.0% (95%CI*: 91.0%~97.6%);

Relative specificity: 99.5% (95%CI*: 98.7%~99.9%);

Accuracy: 98.6% (95%CI*: 97.4%~99.0%). *Confidence Intervals

Sensitivity: The FOB Rapid Test Dipstick (Feces) can detect levels of Fecal Occult Blood as low as 50 ng/mL or 6 μg/g feces.

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.