FOB fecal occult blood rapid test for home use (1 pc/box)

FOB fecal occult blood rapid test for home use

Occult blood in stool refers to hidden or invisible blood present in the feces that cannot be detected with the naked eye. Occult bleeding means that the bleeding occurs in the upper or lower part of the digestive tract, and the blood is not visible during bowel movements.

Detecting occult blood in the stool can be important in diagnosing digestive system problems such as colorectal cancer, colon polyps, or gastrointestinal ulcers. The detection of occult bleeding can help identify gastrointestinal diseases in time, even before they cause noticeable symptoms.

A positive fecal occult blood result does not necessarily mean that someone has cancer or a serious disease. Occult bleeding may also be caused by other, less serious conditions such as hemorrhoids, stomach or duodenal ulcers, inflammatory bowel disease, or bleeding colon polyps. However, detecting occult bleeding is an important step in determining further diagnostic procedures and examinations.

If the fecal occult blood test shows a positive result, further examinations may be required, such as a colonoscopy or other imaging procedures, in order to identify and treat the underlying problem more accurately. It is always recommended to consult a doctor and seek further instructions if the fecal occult blood test shows a positive result or if other digestive system problems are suspected.

The FOB fecal occult blood rapid test is suitable for home use.

FOB Fecal Occult Blood Rapid Test Specification

Product name: FOB Fecal Occult Blood Rapid Test for Home Use
Sample: Stool
Packaging: 1 pc/box
Format: Test strip
Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - ,MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com
EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA,The Hague,Netherlands, peter@lotusnl.com
Expiration date: 30 September 2026
CE-marked in vitro diagnostic medical device in accordance with Directive 98/79/EC (IVDD). This product remains legally marketable under the transitional provisions of Regulation (EU) 2017/746 (IVDR).

Contents of the FOB Fecal Occult Blood Rapid Test Kit

• 1 test device
• 1 sample dilution tube with buffer
• 1 instruction for use 

Test Procedure

Please read the Instructions for Use carefully before performing the test. Allow the test device, specimen, and buffer to reach room temperature (15–30°C) before testing.

1. Sample Collection and Preparation

Unscrew and remove the applicator from the dilution tube. Be careful not to spill or splash the liquid from the tube.

Collect the sample by inserting the applicator stick into the stool sample at least three different locations.

Place the applicator back into the tube and tighten the cap securely. Be careful not to break the tip of the dilution tube.

Shake the sample collection tube vigorously to mix the specimen with the extraction buffer solution.

Prepared samples in the sample collection tube may be stored at –20°C for up to 6 months if the test is not performed within 1 hour after preparation.

2. Testing

Remove the test from the sealed pouch and place it on a clean, flat surface. Label the test with the patient or control identification. For best results, the test should be performed within one hour.

Using a piece of paper towel, break off the tip of the dilution tube. Hold the tube vertically and dispense 3 drops of the solution into the sample well (S) of the test device.

Avoid introducing air bubbles into the sample well (S) and do not add solution to the result window.

As the test begins to work, color will migrate across the membrane.

Read the result after 5 minutes. Do not interpret the result after 10 minutes.

Interpretation of Results

Positive

Two colored lines appear on the membrane. One line appears in the control region (C) and another line appears in the test region (T).

Negative

Only one colored line appears in the control region (C). No colored line appears in the test region (T).

Invalid

The control line does not appear. Tests that do not produce a control line within the specified reading time must be discarded. Please review the procedure and repeat the test with a new device. If the problem persists, stop using the kit immediately and contact your local distributor.

Reliability of the FOB Fecal Occult Blood Rapid Test

• Relative Sensitivity: 97.3%
• Relative Specificity: 98.4%
• Overall Agreement: 98.2%

Instructions