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Feces Specimen FOB Test Kit 50ng/Ml Cut - Off 24 Months Shelf Life CE Approval

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Feces Specimen FOB Test Kit 50ng/Ml Cut - Off 24 Months Shelf Life CE Approval

China Feces Specimen FOB Test Kit 50ng/Ml Cut - Off 24 Months Shelf Life CE Approval supplier
Feces Specimen FOB Test Kit 50ng/Ml Cut - Off 24 Months Shelf Life CE Approval supplier Feces Specimen FOB Test Kit 50ng/Ml Cut - Off 24 Months Shelf Life CE Approval supplier

Large Image :  Feces Specimen FOB Test Kit 50ng/Ml Cut - Off 24 Months Shelf Life CE Approval

Product Details:

Place of Origin: China
Brand Name: New Life
Certification: ISO13485,CE

Payment & Shipping Terms:

Minimum Order Quantity: 5000pcs
Price: USD0.5-USD2
Packaging Details: 1pc/pouch, 25pcs/box
Delivery Time: 20-30days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 2000000pcs/month
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Detailed Product Description
Cat.: Tumor Marker Format: Strip/cassette
Specimen: Feces Testing Time: 5-15 Minutes
Shelf Life: 24 Months Cut-off: 50ng/ml
Application: FOB Test

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
 

 

Product Cat No Specimen   Format Kit Size
Tumor Markers Tests
FOB YT304S3 Feces 50/25/40/200ng/ml Strip 100T/BOX
YT304C4 50/25/40/200ng/ml Cassette 25T/BOX

 

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.

 

Feces Specimen FOB Test Kit 50ng/Ml Cut - Off 24 Months Shelf Life CE Approval

 

 

 

PERFORMANCE CHARACTERS:

 

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

 

Method Other Rapid Test Total Result

FOB Rapid Test Dipstick

(Feces)

Results Positive Negative
Positive 189 4 193
Negative 10 802 812
Total Result 199 806 1005

 

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.

 

 
ORIENT NEW LIFE MEDICAL CO., LTD.
Contact: Jerry Meng
Email: Jerry @ newlifebiotest .com
Tel. +86 18657312116
SKYPE enetjerry

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