Pregnancy stick making by our pregnancy kit company  is a rapid, one-step transverse flow midstream immunoassay used to qualitatively measure  hcg levels in urine to detect pregnancy. The hcg urine test dipstick uses an antibody combination that includes monoclonal hCG antibodies to selectively detect elevated hCG levels. Urine is added to the sampler abserbent and the result is obtained from the color line.                  

As the test sample flows through the hcg pregnancy rapid test dipstick absorption device, the labeled antibody-dye conjugate binds to HCG to form an antibody-antigen complex. When the concentration of HCG in the tested sample is greater than 25mlIU/ml, the complex binds to anti-HCG antibodies in the positive response zone (the T  area) and produces a purple band on hcg dipstick rapid test .When the concentration of HCG in the sample did not reach 25mlIU/ml, there was no line in the positive reaction area. The unbound conjugate binds to the reagent in the control zone (" C "area) to make a purple band indicating normal function of the reagent.  

A.Sensitivity:

As a professional pregnancy kit company,For each batch of hcg urine test midstream, we will sample this indicator to ensure the stability of the  hcg stick test.

Pregnancy stick will detect HCG concentrations between 25mIU/ml to 500,000mIU/ml. The addition of Luteinizing Hormone (LH, 500mIU/ml), Follicle Stimulating Hormone (FSH, 1000mIU/ml) and Thyroid Stimulating Hormone (TSH, 1000IU/ml) to negative specimens (0mIU/ml HCG) showed that these hormones do not impact the one step hcg stick results.  

How to verify whether the results of hcg pregnancy test are stable? See the following steps:

Three transfer batches were used to confirm the variability of the device. One positive solution (25mIU/ml) and one negative solution (0mIU/ml) were tested at o'clock every morning and afternoon. Each solution was tested five times and the results were read within five minutes.

According to the test results, no change is observed, and the performance of the first response test has shown a stable state.               

B.Specificity:

We will also test the specificity of each batch of pregnancy confirmation test midstream. 

The specificity of the pregnancy check kit is as follows:

In order to explore whether these substances interfere with the one-step chorionic pregnancy promotion instrument, the three transfer batches were used to detect different human hormones in women's body.

Positive solution: 1) (1000mIU/ml hFSH, 500mIU/ml hLH, 1mIU/ml hTSH solution mixed with 25miu/ml hCG solution)

Negative solution: 2) (1000mIU/ml hFSH, 500mIU/ml hLH, 1mIU/ml hTSH solution, not mixed with 25miu/ml hCG solution);

Test three times with each concentration of solution. Read the results within 5 minutes.

According to the test results, the one-step hCG pregnancy test is negative when the 25miu/ml hCG solution is not mixed, and positive when the 25miu/ml hCG solution is mixed. Therefore, the hCG test will not cross react with these human hormones (500mIU/ml hLH, 1000mIU/ml hFSH, 1mIU/ml hTSH).                              

C.Accuracy:

We will test the accuracy of each batch of products to ensure that the accuracy rate of this batch of types of pregnancy tests exceeds 99%,This is an important indicator that all pregnancy kit company attach great importance to. 

As reliable as a comparable test from a family doctor. Still, only your family doctor or gynecologist can be absolutely certain that you are pregnant. Your personal health may affect the results of the test. Consult your family doctor if you are pregnant or have any questions about your pregnancy.

D.Expiry date:

As an in vitro diagnostics manufacturers,we inspect each bath to confirm the expiry date is 3 years

E.Traceability of pregnancy check kit Quality 

As a pregnancy kit company, we store samples of all orders for over 3 years. If the customer has questions about the quality, we will find the sample and check the quality. We want to provide the world with the best pregnancy hormone test stick.

Choose the model of the midstream(pen)

Midstream/stick of one step test for hcg: 3.0mm/3.5mm/5.5mm/6.0mm 

We accept ivd oem 's package.Pregnancy stick  can be

(1)50pcs/bag,40bags/carton; 

(2) 1pc/box,432boxes/carton,131760boxes/20GP 

(3) 2pcs/box,432boxes/carton,99360boxes/20GP

About Us

RECARE Group is a medical factory and a leading pregnancy kit company. We develop, manufacture and distribute pregnancy hormone test worldwide, with a production base in Beijing. Our products include Rapid Tests, Elisa kits and are registered under the trademark Recare®. So far, As a pregnancy kit company we passed ISO9001, ISO13485 and has a large production facility of 19,500 square meters, more than 40 products have passed CE certification, we have more than 100 employees for our medical device production , the monthly hcg test kit capacity of more than 50 million pieces, half of our output for the top brands in the Chinese market to provide hcg test at home products OEM. The other half is exported to different countries, Our different types of pregnancy tests exporting to more than 160 countries and regions around the world. We also have medical supply manufacturer,can supply many medical products such as bandages, gauze, bandages, cotton swabs, urine bags, etc.

The process of different pregnancy tests stick order negotiation and production is very simple:

Step 1,For hcg qualitative test stick,we have different shapes plastic mould and different width.We will send you a selection of pictures.

Step 2.Then you can choose the package of hcg kit test stick,bulk packing,small box packing and other packing method you specify

Step 3. How about quantity of one step hcg?

Step 4. We provide OEM service for hcg levels urine test,pls send us design file if you need it.

Step 5.We will check price for one step hcg urine test as your all requirements and send you quotation of total hcg test stick.

If you agree with our price, you can confirm the order. The payment method of oem ivd product order is 30% as deposit, and the balance shall be paid before shipment. The normal delivery time of oem ivd test hcg urine is 30-50 working days after receiving the deposit and all design confirmation.

contact:[email protected]