Human Chorionic Gonadotropin (HCG) Rapid Test Kit
hCG Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine specimens. This kit is intended for use as an aid in the early detection of pregnancy.
For in vitro self test use only.
【CONTENTS】
HCG Test.
Desiccant.
Instruction for use.
【PRINCIPLE】
Human chorionic gonadotropin (hCG), a glycoprotein hormone secreted by viable placental tissue during pregnancy, is excreted in urine approximately 20 days after the last menstrual period. hCG levels rise rapidly, reaching peak levels after 60-80 days.
The appearance of hCG in urine soon after conception and its rapid rise in concentration makes it an ideal marker for the early detection and confirmation of pregnancy. However, elevated hCG levels are frequently associated with trophoblastic and non-trophoblastic neoplasms and hence these conditions should be considered before a diagnosis of pregnancy can be made.
The hCG Rapid Test detects human chorionic gonadotropin through visual interpretation of color development on the strip. Anti-hCG antibodies are immobilized on the test region of the membrane and anti-mouse antibodies on the control region.
During testing, the specimen reacts with anti-hCG antibodies conjugated to colored particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient hCG in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
This kit Sensitivity is 10mIU/ml HCG.
【PRECAUTIONS】
•For professional in vitro diagnostic use only.
•Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
•This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore recommended that these products be treated as potentially infectious, and handled observing usual safety precautions (e.g., do not ingest or inhale).
•Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
•Read the entire procedure carefully prior to testing. Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
•Humidity and temperature can adversely affect results.
•Used testing materials should be discarded according to local regulations.
【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.
【SPECIMEN】
•The hCG Rapid Test is intended for use with human urine specimens only.
•Although urine specimens from any time of day can be used, first morning urine specimens are preferred as they contain the highest concentration of hCG.
•Turbid specimens should be centrifuged, filtered, or allowed to settle and only the clear supernatant should be used for testing.
•Urine specimens must be collected in clean, dry containers. Ensure that the volume of specimen collected is sufficient to submerge the dip region of the strip.
•Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 48 hours. For long term storage, specimens should be kept below - 20°C.
•Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
•If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
【OPERATION】
1. Remove test Strip, Device or Midstream from the sealed pouch.
2.1 Strip:
Remove test strip from the sealed pouch.
Dip the arrowed end of the test strip into the container with urine sample, take it out in 10 seconds and lay flat.
2.2 Device/Cassette:
Remove test device/cassette from the sealed pouch.
Lay the device flat, add 2 drops of urine specimen by sample dropper into the sample well.
2.3 Midstream/Pen:
Remove test midstream from the sealed pouch.
Open the midstream cup, dip the sample collection head into urine sample, take it out in 10 seconds and lay it flat.
3. Read the results within 5 minutes.
【INTERPRETATION OF RESULTS】
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No colored 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.
For further operation or performance details, please refer to final instruction manual.
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