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Fluorescence Immunoassay Test cassette for Quantitative Detection of Fecal Occult Blood

Brand Name:	ALLTEST Novatrend Plus
Model Number:	FI-FOB-602
MOQ:	N/A
Price:	negotiation
Payment Terms:	Ex works

Detail Information

Product Description

Detail Information

Format:

Cassette

Storage Temperature:

4-30℃

Kit Size:

10/25T/kit

Time To Results:

15 Minutes

Specimens:

Feces

Test Range:

10-1000 Ng/mL

Test Type:

Flourescence Immunoassay

Packaging Details:

10T/25T

Highlight:

mab antibodies

hybridoma Monoclonal antibodies

Product Description

The FOB Test Cassette (Feces) is intended for in vitro quantitative detection of Human

Occult Blood in feces.

【SUMMARY】

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.1,2

The FOB Test Cassette (Feces) is a rapid test to quantitatively detect low levels of

Fecal Occult Blood. The test uses a double antibody sandwich assay to selectively

detect Fecal Occult Blood at 10-1000ng/ml. In addition, unlike guaiac assays, the

accuracy of the test is not affected by the diet of the patients.

【PRINCIPLE】

The FOB Test Cassette (Feces) detects Human Occult Blood in feces based on

Fluorescence Immunoassay. The sample moves through the strip from sample pad to

absorbent pad. If the specimen contains hemoglobin, it attaches to the fluorescent

microspheres-conjugated anti-hemoglobin antibodies. Then the complex will be

captured by the capture antibodies coated on the nitrocellulose membrane (Test line).

The concentration of hemoglobin in the sample correlates with the fluorescence signal

intensity captured on the T line. According to the fluorescence intensity of the test and

the standard curve, the concentration of hemoglobin in the sample can be calculated by

Analyzer.

【REAGENTS】

The test includes anti-hemoglobin antibody coated fluorophores and anti- hemoglobin

antibody coated on the membrane.

【PRECAUTIONS】

1. For professional in vitro diagnostic use only.

2. Do not use after the expiration date indicated on the package. Do not use the test if

the foil pouch is damaged. Do not reuse.

3. Avoid cross-contamination of specimens by using a new specimen collection

container for each specimen obtained.

4. Do not eat, drink or smoke in the area where the specimens and tests are handled.

Handle all specimens as if they contain infectious agents. Observe established

precautions against microbiological hazards throughout the procedure and follow

standard procedures for proper disposal of specimens. Wear protective clothing such

as laboratory coats, disposable gloves and eye protection when specimens are

assayed.

5. Do not interchange or mix reagents from different lots.

6. Humidity and temperature can adversely affect results.

7. Used testing materials should be discarded in accordance with local regulations.

8. Read the entire procedure carefully prior to any testing.

9. The FOB Test Cassette should only be used with the Analyzer by approved medical

professionals.

【STORAGE AND STABILITY】

1. The kit should be stored at 4-30 °C until the expiry date printed on the sealed pouch.

2. The test must remain in the sealed pouch until use.

3. Do not freeze.

4. Care should be taken to protect the components of the kit from contamination. Do not

use if there is evidence of microbial contamination or precipitation. Biological

contamination of dispensing equipment, containers or reagents can lead to false results.

【SPECIMEN COLLECTION AND PREPARATION】

1.Specimens should not be collected during or within three days of a menstrual period,

or if the patient suffers from bleeding hemorrhoids or blood in the urine.

2.Alcohol, aspirin and other medications taken in excess may cause gastrointestinal

irritation resulting in occult bleeding. Such substances should be discontinued at least

48 hours prior to testing.

3.No dietary restrictions are necessary before using the FOB Test Cassette.

4.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℃.

【MATERIALS】

Materials Provided

• Test Cassettes

• Specimen Collection Tubes with Buffer

• ID Card

• Package Insert

Materials Required But Not Provided

• Timer

• Centrifuge • Fluorescence Immunoassay Analyzer

• Pipette • Specimen Collection Containers

【DIRECTIONS FOR USE】

Refer to Fluorescence Immunoassay Analyzer Operation Manual for the

complete instructions on use of the Test. The test should be conducted in room

temperature.

Allow the test, specimen, buffer and/or controls to reach room temperature (15-

30°C) prior to testing.

1. Turn on the Analyzer power. Then according to the need, select “Standard Test” or

“Quick Test” mode.

2. Take out the ID card and insert it into the Analyzer ID Card Slot.

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 80 μL) into the specimen collection tube containing the extraction

buffer.

4. Tighten the cap onto the specimen collection tube, and 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. To process fecal specimens:

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 80 μL) to the specimen well of the test cassette,

and then start the timer. Avoid trapping air bubbles in the specimen well. See illustration

below.

7. There are two test modes for Fluorescence Immunoassay Analyzer,

Standard Test mode and Quick Test mode. Please refer to the user manual of

Fluorescence Immunoassay Analyzer for details.

“Quick test” mode: After 15 minutes of adding sample, Insert the test cassette into

the Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST"

immediately. The Analyzer will automatically give the test result after a few seconds.

“Standard test” mode: Insert the test cassette into the Analyzer immediately after

adding specimen, click “STANDARD TEST”, fill the test information and click "NEW

TEST" at the same time, The Analyzer will automatically countdown 15 minutes. After

the countdown, the Analyzer will give the result at once.

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products details

Fluorescence Immunoassay Test cassette for Quantitative Detection of Fecal Occult Blood

Fluorescence Immunoassay Test cassette for Quantitative Detection of Fecal Occult Blood

mab antibodies

hybridoma Monoclonal antibodies