Hcg pregnancy tests stick (midstream ) pregnancy test kit manufacturer
Model: pregnant pregnancy kit Midstream
Expiry Date: 3 years/36 months
Instrument Classification:Class II
Quality Certification: CE ISO FSC
Specificity:25 mIU/ml Hcg 99%
Accuracy:more than 99%.
Storage:Store the test at 4~30 ° C (room temperature).Avoid sunlight.
Scientific name:One step hCG pregnancy Test (Midstream)
One step hCG pregnancy Test(hcg test at home) is an automatic immune detection method, which aims at qualitative detection of HCG in urine to detect pregnancy early. The pregnancy hormone test device is intended for self-testing. HCG is a glycoprotein hormone secreted by the developing placenta shortly after fertilization. During a normal pregnancy, HCG can be detected in urine as early as seven days after conception, with levels doubling every 1.3 to 2 days. At the time of the last missed menstrual period, urine HCG levels were approximately 100mlU per milliliter, reaching peak levels of 100,000 to 200000mlU per milliliter at the end of the first trimester. The presence of HCG for a certain period of time shortly after pregnancy and its subsequent increase in concentration during early pregnancy growth make it an ideal marker for early detection of pregnancy. The pregnancy confirmation test Stick， is a rapid qualitative one step assay for the detection of HCG in urine. This method uses a unique combination of monoclonal dye conjugates and polyclonal solid-phase antibodies to selectively identify HCG in HCG test samples with extremely high sensitivity. HCG levels as low as 25mlU/ml could be detected by pregnancy stick in less than 5 minutes.
As the HCG test sample for pregnancy check kit/different types of pregnancy tests flows through the absorbent device, the labeled antibody-dye conjugate binds to the HCG forming an antibody-antigen complex. At concentrations of HCG greater than 25mlIU/ml, the complex binds to anti-HCG antibodies in the positive reaction zone (” T “zone) and produces a pink-purple band. In the absence of HCG, there is no line in the positive zone. The unbound conjugate binds to the reagent in the control zone (” C “zone), producing a pink-purple band when performed on test for pregnancy at home , demonstrating that the hcg rapid test are functioning properly.
The choice of pregnancy tests stick(midstream)
A.Sensitivity:1. ANALYTICAL SENSITIVITY & DIAGNOSTIC SENSITIVITY We use the most scientific method to detect the sensitivity of each batch of hcg pregnancy rapid test dipstick to ensure their stability and accuracy.
The hcg urine test is a very rapid test used to qualitatively measure the amount of hCG in urine at 25mlU/ml. Both analytical and diagnostic sensitivity were 25mIU/ml.
For sensitivity of hcg urine dipstick, the specific detection methods are as follows： Three transfer batches were used to confirm the variability of the hcg urine test dipstick, testing one positive solution (25mIU/ml) and one negative solution (0mIU/ml) at morning and afternoon time points each day, five times each, and reading the results within five minutes.
According to the test results of pregmate hcg test midstream , no variable results are observed and the device performance has shown steady state. As a professional pregnancy test kit manufacturer, we strictly guarantee the thoroughness of inspection and the accuracy of data.
B.Specificity:We will also carry out specificity testing for each batch of hcg stick.Use the three transfer lots to test different human hormone of women, to investigate that if those materials interference to the first response test. The specific detection specificity of hcg dipstick rapid test methods are as follows,
Negative solutions: 1) (500mIU/ml hLH, 1000mIU/ml hFSH, and 1mIU/ml hTSH solutions without 25 mIU/ml hCG solution mixing);
Positive solutions: 2) (500mIU/ml hLH, 1000mIU/ml hFSH, and 1mIU/ml hTSH solutions with 25 mIU/ml hCG solution mixing)
And each concentration have tests three times. Read results on pregnancy confirmation test within 5 minutes.
According to the test results, pregnancy check kit had shown the negative results when tested the human hormone without 25 mIU/ml hCG solution mixing, and shown the positive results when tested the human hormone with 25 mIU/ml hCG solution mixing, so the pregnancy hormone test will not cross-react with these human hormones(500mIU/ml hLH, 1000mIU/ml hFSH, and 1mIU/ml hTSH). As a strict pregnancy test kit manufacturer, We should always monitor this important indicator.
C.Accuracy:We will test the accuracy of each batch of hcg sticks to ensure that the accuracy rate exceeds 99%. Test accuracy was assessed by comparing commercially available pregnancy lab test using 203 urine samples, including 118 patients with a clinical diagnosis of nonpregnancy and 85 patients with a diagnosis of pregnancy. The pregnancy hormone test had 85 positive results and 118 negative results, showing a 100% correlation with the hcg test at home and the physician’s clinical interpretation. The hcg test kit was more than 99% accurate. All pregnancy test kit manufacturer thinks this indicator is the most important.
Midstream/stick of one step test for hcg: 3.0mm/3.5mm/5.5mm/6.0mm
In 2000, we began to invest in rapid detection plants to produce oem medical rapid diagnostic tests. As a medical manufacturer and in vitro diagnostics manufacturers We have more than 100 employees, and the monthly testing capacity is more than 20million pieces. Our one step hcg test products have been sold to more than 160 countries and regions worldwide. HCG combo rapid test provided by Recare,the medical manufacturing companies ,is highly valued for its high accuracy and reliability in both commercial and non-commercial markets.We supply 50% of our fast detection products to top brands in the Chinese market and OEM them. 50% of the different types of pregnancy tests are exported to different countries.We always pay attention to the needs of users and customer requirements, and study how to improve the quality of our products.hcg hormone test is the main product of our factory.At the same time, we can produce many different types of IVD tests, such as HIV, malaria, dengue fever, HBV, HbsAg… drug tests,… It has always been our goal to provide customers with perfect fast tests.
It only takes 5 steps and you can order oem medical products from us
Step 1, We have different format for premom hcg test,like strip(pregnancy stick)/cassette(hcg card test)midstream,which type do you need?
Step 2. We have different package of urine test for pregnancy at home,like bulk packing,small box packing…we also have different size&plastic model for urine test during pregnancy,pls send us your requirement of easy at home hcg test.
Step 3. How about quantity you need?
Step 4. If you need ivd oem hcg pregnancy rapid test dipstick urine (customized brand) pls send us your design file of hcg pregnancy rapid test.
Step 5. We will check price as your requirement of hcg stick test and send you quotation.Then you can confirm order if price is ok.Payment term of oem ivd product order is 30% as deposit , the balance will be paid before shipping . Normal delivery time is 30-50 working days after deposit received and all design confirmed.
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