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Fecal Lactoferrin as a Biomarker Lactoferrin Rapid Test for Infectious Disease Testing test line

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

Detail Information

Product Description

Detail Information

Certification:

Test Time:

5 Minutes

Kit Size:

1/10T

Test Result:

Accurate And Reliable

Detection Method:

Chromatographic Immunoassay

Cut Off:

See Insert

Specificity:

High

Sample:

Feces

Intended Use:

For Diagnosis And Monitoring Of Infectious Diseases

Packaging Details:

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

Supply Ability:

2000mg/month

Highlight:

recombinant antigen

Recombinant Proteins

Product Description

A rapid, one step test for the qualitative detection of lactoferrin in human feces.

For professional in vitro diagnostic use only.

【INTENDED USE】

The Lactoferrin Rapid Test (Feces) is a rapid chromatographic immunoassay for the

qualitative detection of lactoferrin in human feces to aid in the diagnosis of inflammatory

gastrointestinal disorders.

【SUMMARY】

Inflammatory bowel disease (IBD) involves a large clinical spectrum of disease presentations

from mild to severe symptoms in relation to different disease locations and the extent from

possible rectal to upper intestinal involvement. In pediatric patients, early diagnosis of IBD is of

great relevance and essential for best outcome. Induction of remission by specific therapy

aims to improve the patient’s symptoms, to maintain or restore the quality of life as soon as

possible, and to prevent complications of the disease.1,2,3 Human lactoferrin, a neutrophil

derived glycoprotein, can be measured in feces and whole gut lavage as an indicator of

intestinal inflammation in both IBD and infectious gastroenteritis. Recent studies have shown

fecal lactoferrin (FL) as a sensitive biomarker for pediatric IBD. In addition, this biomarker can

serve as an aid for guiding the diagnostic and therapeutic process for both pediatric and adult

IBD.

【PRINCIPLE】

The Lactoferrin Rapid Test is a qualitative, lateral flow immunoassay for the detection of

Lactoferrin in human fecal specimen. The membrane is pre-coated with anti-Lactoferrin

antibody on the test line region of the test. During testing, the specimen reacts with the particle

coated with Lactoferrin antibody. The mixture migrates upward on the membrane by capillary

action to react with anti-Lactoferrin 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 mouse anti-lactoferrin antibody particles and mouse anti-lactoferrin antibody

coated on the membrane.

【WARNINGS AND 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 expiration date. Do not reuse the test.

• The test should remain in the sealed pouch until use. Do not use test if the pouch is damaged.

• 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.

• Wear protective clothing such as laboratory coats, disposable gloves and eye protection

when specimens are assayed.

• Please ensure that an appropriate amount of samples are used for testing. Too much or

too little sample size may lead to deviation of results.

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

• Humidity and temperature may adversely affect results.

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

manufacturer and the competent authority.

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

【STORAGE AND STABILITY】

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

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

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

Note: It is suggested to use test within one hour after removing it from the foil pouch.

【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.

【MATERIALS】

Materials Provided

 Test Cups (with dilution buffer)

 Package Insert

Materials Required But Not Provided

 Specimen Collection Container

 Timer

 Pipette

 Droppers

【DIRECTIONS FOR USE】

Before performing the test, allow the test specimen and cup to reach room temperature

(15-30°C), stool samples must be collected following the instruction below.

1. Wash hands with soap and rinse with clear water.

2. 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°C if not tested within 6 hours. For long term storage, specimens should be kept below -20°C.

3. 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.

4. To process fecal specimens:

For Solid Specimens:

Unscrew the cap of the test cup, 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 specimen, and then transfer 2 drops of the liquid

specimen (approximately 80 µL) into the test cup containing the dilution buffer.

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

6. Shake the test cup for about 10-15 seconds to mix well. Leave the cup for reaction for 2

minutes.

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

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

and start the timer.

NOTE: Keep the test cup upright during the test developing. Do not move or turn the test cup

upside down.

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

Tags:

rapid test kit

diagnostic tests for infection

infectious disease diagnostic tests

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products details

Fecal Lactoferrin as a Biomarker Lactoferrin Rapid Test for Infectious Disease Testing test line

Fecal Lactoferrin as a Biomarker Lactoferrin Rapid Test for Infectious Disease Testing test line

recombinant antigen

Recombinant Proteins