Specifications
1.Early pregnancy test
2.Sensitivity: 10~50 mIU/ml
3.Fast: read result in 3~5 minutes
4.One step strip kit use
5.CE&ISO13485
1. Brief Introduction of Pregnancy Test Kit
The 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.
For self-testing and in vitro diagnostic use only
2. The Features of Pregnancy Test Kit
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Sensitivity: |
50, 25,20 ,10 mIU/mL or as your required |
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Accuracy: |
>99% |
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Result : |
2~5 minutes |
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Intended Use: |
Professional (Lab. Hospital, Clinic etc) & Home use |
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Specimen: |
Urine, better early morning, no fluid drank beforehand |
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Packing: |
Foiled with Pipette, desiccant or OEM |
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Format: |
Midstream,Strip,Cassette; |
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Certificate: |
CE0197, ISO13485; |
3. The Principle of Pregnancy Test Kit
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 50mIU/ml.
The test reagent is exposed to urine, allowing urine to migrate through the absorbent test strip. The labeled antibody-dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the test region (T) and produces a red line when hCG concentration is equal to or greater than 25mIU/ml. In the absence of hCG, there is no line in the test region (T). The reaction mixture continues flowing through the absorbent device past the test region (T) and control region (C). Unbound conjugate binds to the reagents in the control region (C), producing a red line, demonstrating that the test strip is functioning correctly.
4.The Procedure of Pregnancy Test Kit
Read the entire procedure carefully before performing any tests.
Allow test kits and urine samples to equilibrate to room temperature (20-30°Cor 68-86°F) prior to testing.
[for pregnancy test strip/dipstick]
- Remove the test strip/dipstick from the sealed pouch.
- Holding the strip/dipstick vertically, carefully dip it into the specimen with the arrow end pointing towards the urine. NOTE: Do not immerse the strip/dipstick past the Max Line.
- Remove the strip/dipstick after 10 seconds and lay the strip/dipstick flat on a clean, dry, non-absorbent surface, and then begin timing.
- Wait for colored lines to appear. Interpret the test results at 3-5 minutes.NOTE: Do not read results after 5 minutes.
[for pregnancy test cassette]
- Remove the test cassette from the sealed pouch.
- Hold the dropper vertically and transfer 3 full drops of urine to the specimen well of the test cassette, and then begin timing.
- Wait for colored lines to appear. Interpret the test results at 3-5 minutes. NOTE: Do not read results after 5 minutes.
[for pregnancy test midstream]
- Remove the test midstream/stick from the sealed pouch.
- Remove the Cap and hold the midstream/stick with the exposed Absorbent Tip pointing downward directly into your urine stream for at least 10 seconds until it is thoroughly wet. NOTE: If you prefer, you can urinate into a clean and dry container, then dip only the Absorbent Tip of the midstream/stick into the urine for at least 10 seconds.
- After removing the midstream/stick from your urine, immediately replace the Cap over the Absorbent Tip, lay the midstream/stick on a flat surface with the Result Window facing, and then begin timing.
- Wait for colored lines to appear. Interpret the test results at 3-5 minutes. NOTE: Do not read results after 5 minutes
Warnings and Precautions!!!
- For in vitro diagnostic use only.
- Please read all the information in this leaflet before performing the test.
- Do not use the kit beyond the labeled expiry date.
- Do not open the sealed foil pouch until you are ready to start the test.
- Do not touch the membrane located within the Result Window.
- 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.
- Do not reuse the test cassette. Discard it in the dustbin after testing.
- All urine specimens and used cassette should be considered potentially infectious and avoided contact with skin.
1. Our service
Gemc are synonymous with quality, personalized service and a commitment to excellence. With our specialized rapid, diagnostic test technologies, high quality assurance, brand recognition, innovative research and development techniques, customer-centric design, an experienced management team, and an energetic sales force, Gemc continues to set the standards in product quality and reliability. We believe in continually improving our products and service, and making the business relationship a beneficial experience for both customers and employees.
Based on our core competence in rapid test technology, high quality assurance in products, international renowned brand name, innovative R&D, customer-centric product design as well as strong sales network, the experienced management team and energetic sales force of Gemc will lead our life to achieve peacefulness, harmony, and higher quality.
2. How to order our product
(1) Customers to contact to consult , and purchase our products
(2) Our trader make a perfessional form according to your product
(3) Inform the product you need after you confirmation of the product
Q1: What's the method u use to do the test?
A: Colloidal Gold Method.
Q2: What's ur MOQ ?
A: Always, for strip format, the MOQ is 5000pcs. While for cassette format, MOQ is 2000pcs, same as midstream.
Q3: What's ur packing of the tests?
A: If u choose the low cost, we will suggest u the bulk packing to go. Which means 1 test in a single pouch, then 100/40 pouches in a plastic bag, 50 bags in a carton. If u need to sell in pharmacy/chain shop or some countries which have strict requirements about the packing, u can choose to pack in a box, like 100pcs in a box, or even 1 test in a single box.
Q4: What's the main differences when comparing products from different suppliers?
A: U can compare the mainly features of the test: Accuracy, Sensitivity, Specificity, and then the Price.
Q5: Some tests can be tested with serum/plasma or with whole blood, so what's the difference?
A: Well, if the specimen is whole blood, people will need buffer, lancet and alcohol swab to help the test. If they buy all the accessories, they can test very easily at home. But if the specimen is serum/plasma, it will need centrifuge to separate serum from whole blood first. This way, it's better to use at lab or hospital. And in some words, serum/plasma test will always give a more accurate results.
Q6: How can i distinguish a good test kit?
A: U can judge from the 4facts:Technical data: Such as the accuracy, specificity and sensitivity.
Pouch sealing: Tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of antibodies labeled on NC membrane. Shelf life will be shorten down.
Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. U can refer to the instruction for more accurate time.
Background: Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice
Telephone: 86-371-60997506
Fax: 86-371-60997506
Website: http://www.gv-medic.com
Address: NO.20,Bosong Road, Zhengzhou, Henan ,China
Zip: 450001
City: Zhengzhou
Country: China (Mainland)
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