CE Filariasis IgM/IgG Rapid Test Kit High Accuracy Quick Diagnostic
【INTENDED USE】
The Filariasis IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-lymphatic filarial parasites (Wuchereria Bancrofti, Brugia Malayi and Brugia Timori) in human serum, plasma or whole blood.This test is intended to be used as a screening test and as an aid in the diagnosis of infection with lymphatic filarial parasites. Any reactive specimen with the Filariasis IgG/IgM Rapid Test must be confirmed with alternative testing method(s).
For professional use only.
For in vitro diagnostic use only.
【OPERATION】
【SAMPLE COLLECTION】
The Filariasis IgM/IgG Antibody Rapid Test can be performed on plasma, serum, or whole blood.
Serum and plasma:
Test specimens as soon as possible after collecting. Store specimens at 2°C -8°C if not tested immediately. Specimens can be stored at 2°C -8°C for up to 5 days. The plasma and serum specimens should be frozen at -20°C for longer storage.
Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.
Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.
Whole Blood:
Whole blood can be obtained by either fingertip puncture or venipuncture. Whole blood specimens should be stored in refrigeration (2°C-8°C), if not tested immediately. The specimens must be tested within 24 hours of collection.
【DIRECTION OF USE】
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean,level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.
2. Transfer 1 drop of whole blood, serum or plasma specimen to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer and start the timer.
3. Wait for colored line(s) to appear. Interpret the test results in 15minutes. Do not read results after 20 minutes.
【INTERPRETATION OF RESULTS】
Preliminary positive (+) Only one colored band appears, in the control region (C). No colored band appears in the test region (T).
Negative (-) Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
Invalid Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded.
Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
【CONTENTS】
Test cassette
Desiccant
Leaflet with 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.
【Manufactured by】
DEWEI MEDICAL EQUIPMENT CO.,LTD
5th floor, No. 4 building, Shiyou Industrial Park, Jun'an , Shunde, Foshan, China 52832
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