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Transferrin and Hemoglobin Test for Colorectal Cancer Diagnosis Infectious Disease Testing lateral flow immunoassay

Brand Name:	ALLTEST
Model Number:	TTFC-607
MOQ:	N/A
Price:	negotiation
Payment Terms:	Ex works
Supply Ability:	2000ml/month

Detail Information

Product Description

Detail Information

Certification:

Test Interpretability:

Easy To Interpret

Sensitivity:

High

Pack:

1T/10T

Sample:

Feces

Test Result:

Accurate And Reliable

Storage:

2-30°C

Reading Time:

5 Minutes

Shelf Time:

24months

Packaging Details:

0.5mg/tube 1mg/tube, 2mg/tube、5mg/tube、10mg/tube、20mg/tube、30mg/tube

Supply Ability:

2000ml/month

Highlight:

polyclonal antibody production

custom polyclonal antibody

Product Description

A rapid, one step test for the qualitative detection of transferrin and hemoglobin in human

feces.

For professional in vitro diagnostic use only.

【INTENDED USE】

The Transferrin/FOB Combo Rapid Test is a rapid chromatographic immunoassay (non

invasive assay) for the qualitative detection of transferrin and hemoglobin in human fecal

specimens, as an aid in the diagnosis of bleeding gastrointestinal disorders.

【SUMMARY】

Colorectal cancer is cancer that occurs in the colon or rectum, and affects both men and

women of all racial and ethnic groups, and is most often found in people aged 50 years or

older. For men, colorectal cancer is the third most common cancer after prostate and lung

cancers. For women, colorectal cancer is the third most common cancer after breast and lung

cancers.1

Fecal occult blood should be an important indicator in the diagnostic evaluation of patients

with suspected gastrointestinal bleeding of any etiology, not just as an indication of colorectal

cancer. The presence of human hemoglobin in feces is inadequate as a screening test for

stomach cancer (upper gastrointestinal disorders), because of human hemoglobin derived

from the upper digestive tract is broken down in the intestinal tract (the antigenicity is lost).2

Detection of fecal transferrin, which is more stable in stool than hemoglobin, provides an

alternative way of diagnosing the disease in the upper digestive tract.2

Blood in the stool may be the only symptom of cancer, but not all blood in the stool is caused

by cancer. Other conditions that can cause blood in the stool include: Haemorrhoids, Anal

fissures, Colon polyps, Peptic ulcers, Ulcerative colitis. Gastroesophageal reflux disease

(GERD). Crohn's disease, use of non-steroidal anti-inflammatory drugs (NSAIDs).3

【PRINCIPLE】

The Transferrin/FOB Combo Rapid Test (Feces) is a qualitative, lateral flow immunoassay for

the detection of human transferrin and hemoglobin in feces. The membrane is precoated with

anti-transferrin antibody and anti-hemoglobin antibody on the test line regions of the

Transferrin and FOB. During testing, the specimen reacts with the particle coated with anti

transferrin antibody and/or anti-hemoglobin antibody. The mixture migrates upward on the

membrane chromatographically by capillary action to react with anti-hemoglobin antibody

and/or anti-transferrin 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.

【REAGENTS】

The test contains anti-hemoglobin antibody, anti-transferrin antibody particles and anti

hemoglobin antibody, anti-transferrin coated on the membrane.

【PRECAUTIONS】

Please read all the information in this package insert before performing the test.

• For professional in vitro diagnostic use only.

• Do not use after the expiration date. Do not reuse the test.

• Store in a dry place at 2-30°C, avoiding areas of excess moisture. If the foil packaging is

damaged or has been opened, please do not use.

• Do not eat, drink or smoke in the area where the specimens or kits are handled.

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

against microbiological hazards throughout all procedures and follow the standard

procedures for proper disposal of specimens.

• The used test should be discarded according to local regulations.

• Humidity and temperature may adversely affect results.

• Wash hands thoroughly before and after handling.

• Any serious incident that has occurred in relation to the device shall be reported to the

manufacturer.

• Components provided in the kit are approved for use in the rapid test. Do not use any

other commercial kit component.

• Use the test only once. Keep the test upright while testing. Do not move or turn the

test upside down.

• The kit must not be frozen.

【STORAGE AND STABILITY】

The kit can be stored at room temperature or refrigerated (2-30°C). The kit is stable through

the expiration date printed on the sealed pouch. The kit must remain in the sealed pouch until

use. DO NOT FREEZE. Do not use beyond the expiration date.

【SPECIMEN COLLECTION AND PREPARATION】

• 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.

• 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.

• No dietary restrictions are necessary before using the Transferrin/FOB Combo Rapid Test.

【MATERIALS】

Materials Provided

 Test Cups (with dilution buffer)

 Package Insert

Materials Required But Not Provided

 Specimen Collection Containers

 Timer

【DIRECTIONS FOR USE】

Allow the test, specimen to reach room temperature (15-30°C) prior to testing.

1. To collect fecal specimens:

Collect sufficient quantity of feces (1-2g) in a clean, dry specimen collection container. 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°C if not tested within 6 hours.

2. Bring the pouch to room temperature before opening it. Remove the test cup 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.

3. To process fecal 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.

4. Insert the specimen collection applicator back into the test cup and tighten the cap.

5. Shake the test cup for about 10-15 seconds to mix well. Leave the cup for reaction for

2 minutes.

6. Remove the plastic limit strip of the test cup.

7. Put the test on a clean and level surface, press the cup body from the top to the bottom

and start the timer.

NOTE: Keep the test upright while testing. Do not move or turn the test upside down.

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

NOTE: If the specimen does not migrate (presence of particles), open a new test cup, repeat

step 3 and centrifuge the diluted specimen contained in the test cup with a clean tube. Pipette

1-1.5 mL of supernatant, dispense into the test cup and insert the specimen collection

applicator back into the test cup and tighten the cap. Continue from step 6-7 onwards in the

above instructions for use and start the timer.

Tags:

rapid test kit

diagnostic tests for infection

infectious disease diagnostic tests

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products details

Transferrin and Hemoglobin Test for Colorectal Cancer Diagnosis Infectious Disease Testing lateral flow immunoassay

Transferrin and Hemoglobin Test for Colorectal Cancer Diagnosis Infectious Disease Testing lateral flow immunoassay

polyclonal antibody production

custom polyclonal antibody