Basic Info.
Accuracy
Above 99%
Certification
CE
Appilcation
HCG Detection
Storage Temperature
4-30ºC
Shelf Life
24 Months
Pack Size
1test/1 Box
OEM
Acceptable
Trademark
Testsealabs
Origin
Hangzhou, China
Production Capacity
5000000sets/Year
Product Description
Testsealabs One Step HCG Test Strip Early Pregnancy Test Kit Home Use Rapid IVD Cassette With High Accuracy
lHigh sensitivity:99%
lConvenient detection:3~5 min amplification
lCertification: CE
lSpecification: 1 test/box
[INTRODUCTION]
Testsealabs HCG Pregnancy Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
As with all diagnostic tests, a final clinical diagnosis should not be based on the results of a single test, but should only be made by a physician after all clinical and lab findings have been evaluated.
| Product name: | Testsealabs One Step HCG Test Strip |
| Assay type: | Urine sample |
| Reading time: | 3~5 min |
| OEM | Acceptable |
| Pack size: | 1test/1 box |
| Storage temperature: | 4-30ºC |
| Shelf life: | 24 months |
[PRODUCT FEATURE]
Easy to Use
Fast Result
High Accuracy
Good Quality
[Principle]
Because the amount of a hormone called human chorionic gonadotropin (hCG) in your body increases rapidly during the first two weeks of pregnancy, the test strip will detect the presence of this hormone in your urine as early as the first day of a missed period. The test strip can accurately detect pregnancy when the level of hCG is between 10mIU/ml to 500,000mIU/ml.
[MAIN COMPONENTS]
The test strip consists of colloidal gold-monoclonal antibody against hCG coated on polyester membrane, and monoclonal antibody against hCG and goat-anti-mouse IgG coated on cellulose nitrate membrane.
Each pouch contains one test strip and one desiccant.
[Storage Conditions And Shelf Life]
1.Store as packaged in the sealed pouch at room temperature (4-30ºC or 40-86ºF). The kit is stable within the expiry date printed on the labeling.
2.Once open the pouch, the test strip should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.
[Materials Provided]
· Specimen collection container
· Timer
[Sample Requirements]
First morning urine usually contains the highest concentration of hCG and is therefore the best specimen when performing the urine test. However, urine collected at any time of day may be used. The urine specimen must be collected in a clean, dry container either plastic or glass.
[Testing Method]
Read the entire procedure carefully before performing any tests.
Allow test strip and urine specimen to equilibrate to room temperature (20-30ºC or 68-86ºF) prior to testing.
1.Remove the test strip from the sealed pouch.
2.Holding the strip vertically, carefully dip it into the specimen with the arrow end pointing towards the urine.
NOTE: Do not immerse the strip past the Max Line.
3.Remove the strip after 10 seconds and lay the strip flat on a clean, dry, non-absorbent surface, and then begin timing.
3.Wait for colored lines to appear. Interpret the test results at 3-5 minutes.
NOTE: Do not read results after 5 minutes.
[Quality control ]
·False-negative readings can occur when testing is done too early. In order to get the most accurate results, it is a good idea to wait for about a week after your period is due before testing. This allows more hCG to build up in your urine, which will allow for a more accurate test.
·Drinking too much fluid before taking the test may cause a false-negative result. For the most accurate results, take the test first thing in the morning when the urine is the most concentrated.
·Certain fertility medications which contain hCG (such as Pregnyl, Profasi, Novarel) can give a false-positive result. Alcohol, oral contraceptives, birth control pills, analgesics (pain killers), antibiotics or hormone therapies that do not contain hCG should not affect the test result.
·A number of medical conditions other than pregnancy, including ovarian cyst, choriocarcinoma or ectopic pregnancy (pregnancy outside the uterus) can cause elevated levels of hCG.
·Using the test strip within 8 weeks of giving birth or having a miscarriage may also cause a positive result. You should ask your doctor for help in interpreting your test result if you have had the experience of pregnancy described above recently.
[Results interpretation]
Positive: Two distinct red lines will appear, one in the test region (T) and another in the control region (C). You can assume that you are pregnant.
Negative: Only one red line appears in the control region (C). No apparent line in the test region (T). You can assume that you are not pregnant.
Invalid: The result is invalid if no red line appears in the control region (C), even if a line appears in the test region (T). In any event, repeat the test. If the problem persists, discontinue using the lot immediately and contact your local distributor.
NOTE: Clear background in the Result Region can be seen as a basis for effective testing. If the test line is weak, it is recommended that the test be repeated with the first morning specimen obtained 48-72 hours later. No matter how the test results, it is recommended to consult your physician.