Cost Effective Giardia Lamblia Antigen (GIA)Rapid Test in Human Feces

【INTENDED USE】

The Giardia (GIA) Antigen Rapid Test Kit is a chromatographic immunoassay for the qualitative detection of Giardia antigen in canine or feline stool (feces).

【PRINCIPLE】

The invisible anti-GIA antibody (T line) and secondary antibody (C line) are immobilized on a nitrocellulose membrane in result window.Another anti-GIA antibody is conjugated with colloidal gold particle and immobilized on glass fiber as conjugate pad.When spcimen is applied into the sample well on device, GIA antigen will bind to the gold conjugate and migrate on the surface of test strip by passive diffusion,and a visible T line will appear in result window.The C line has to appear every time when the test has performed which indicates the test is performing properly.

【CONTENTS】

• Rapid Test

• Buffer

• Disposable pipettes

• Swab

• Instruction for use

【STORAGE AND STABILITY】

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.

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

• Keep away from direct sunlight, moisture and heat.

• Do not freeze.

• 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.

【SAMPLE COLLECTION AND PREPAIRATION】

• Specimen of this test is canie or feline stool (feces).

• The specimens should be tested immediately after collection.

• If specimens are not tested immediately, they should be stored at 2~8°C for 24hours. For longer storage, freeze at -20°C or below.

• Feline stool(feces) should be collected as shown in the picture on the below. Excessive fecal amount may induce a false positive result.

【OPERATION】

Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.

1. Use swab to collect canine or feline stool (feces), then insert the swab into the assay buffer tube.

2. Mix the swab until the specimen has been dissolved totally into the assay buffer (Appx. 10s).

3. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the cassette device with animal patient or control identification.

4. Transfer 3 drops of mixing buffer into the sample well on device, drop by drop vertically, and start the timer.

5. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

【INTERPRETATION OF RESULTS】

POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.

INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.

【PRECAUTIONS】

• The test kit is for canine or feline use only. Donot useforother animals.

• The device is sensitive to humidity and heat. Performthetest immediately after removing it fromthe foil pouch.

• Read the instructions carefully before operationandfollow the instructions.

• Do not reuse the test components

• Do not use the test kit if the pouch is damagedorthesealis broken.

• Do not use the test kit beyond the stated expirationdatemarked on the label.

• Do not mix components fromdifferent lot numbersbecause the components in this kit have beenqualitycontrol tested as standard batch unit.

• All specimens should be handled as beingpotentiallyinfectious.

• Decontaminate and dispose of all specimens, usedkitsand potentially contaminated materials safelyinaccordance with national and local regulations.

【TEST LIMITATIONS】

• This kit can provide fast and easy way toget aresult,butdo not completely exclude the possibilityofalowincidence of false results which occur byvariousfactors,veterinarians should also consider otherclinicalsymptoms and laboratory diagnostic methods tomakethedefinite diagnosis.

• The kit will only indicate the presence of giardiaantigenin the specimen or not.

• A negative result may be obtained if the concentrationofthe giardia antigen present in the specimenis not adequateor is below the detectable level of the test.