Easy Use Rapid Test Reader , Single Fob Medical Product High Accuracy

Application:

Fecal Occult Blood (FOB) is the hidden blood in the feces which can be found in many gastrointestinal diseases. 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.

Description:

Many diseases can cause hidden blood in the feces. This is also known as Fecal Occult Blood (FOB), Human Occult Blood, or Human Hemoglobin. 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 methods lack sensitivity and specificity, and also have diet restrictions prior to testing.

The FOB Rapid Test Cassette (Feces) is a rapid test to qualitatively detect low levels of Fecal Occult Blood. The test uses a double antibody sandwich assay to selectively detect Fecal Occult Blood at 50ng/ml or higher, or 6μg/g feces. In addition, unlike guaiac assays, the accuracy of the test is not affected by the diet of the patients.

How to use?

Allow the test cassette, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1.Exact QR Code from the QR code card for specific information of the test. Use only QR code card provided inside the test kits.

2.To collect fecal specimens:

Collect sufficient quantity of feces (1-2mL or 1-2g) 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℃.

3.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 80μL) into the specimen collection tube containing the extraction buffer.

4.Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the tube alone for 2 minutes.

5.Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.

6.Hold the specimen collection tube upright and open the cap onto the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80μL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.

7.Wait for the colored line(s) to appear. The result should be read with LF Reader at 5 minutes.

Note: If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80μL of supernatant, dispense into the specimen well (S) of a new test cassette and start afresh following the instructions mentioned above.

8.Do not interpret test results visually.

Note: For LF the Reader installation, start up and complete instructions refer to the LF Reader User Manual. Operator must consult the LF Reader User Manual prior to use and become familiar with the processes and quality control procedures.

INTERPRETATION OF RESULTS

Results read by Ciest LF reader

The result of positive or negative for Fecal Occult Blood (FOB) is determined by the Ciest LF reader.

Result could be exported to excel.

Order Information

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.