Audited Supplier
HCG
IVD Reagent
Rapid Test
Urine/Serum
Within 3 Mins
2~30 º C
Immunochromatography
24 Months
CE
Professional Used
Dewei
100tests/Box, 40tests/Box, 1test/Box
1000tests/Carton
China
Product Description
INTENDED USE
hCG Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionicgonadotropin 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.
PRINCIPLE
Human chorionicgonadotropin (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 chorionicgonadotropin 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.
WARNINGS AND PRECAUTIONS
Immunoassay for in vitro diagnostic use only.
Do not use after expiration date.
The test should remain in the sealed pouch until use.
The used test 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.
OPERATION
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
1. Remove test Strip, Device or Midstream from the sealed pouch.
2.1 Strip:
POSITIVE: 2 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 1 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 in vitro self test use only.
| Storage | 2~30 º C |
| Specimen | Urine/Serum |
| Component | Rapid Test + Pipettes |
| Principle | Colloidal gold rapid tests |
| Reading | Within 5mins |
| Package | 40tests/box |
| Trademark | Dewei |
| Origin | China |
PRINCIPLE
Human chorionicgonadotropin (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 chorionicgonadotropin 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.
WARNINGS AND PRECAUTIONS
Immunoassay for in vitro diagnostic use only.
Do not use after expiration date.
The test should remain in the sealed pouch until use.
The used test 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.
OPERATION
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
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 5
seconds and lay flat.
2.2 Device/Cassette:
Remove test device/cassette from the sealed pouch.Lay the device flat, add 2-3 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 5 to 10
seconds and lay it flat.
3. Read the results within 5 minutes.
INTERPRETATION OF RESULTScontainer with urine sample, take it out in 5
seconds and lay flat.
2.2 Device/Cassette:
Remove test device/cassette from the sealed pouch.Lay the device flat, add 2-3 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 5 to 10
seconds and lay it flat.
3. Read the results within 5 minutes.
POSITIVE: 2 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 1 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.
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