China Wholesale Covid19 Whatsapp Test Kits Manufacturers Pricelist - One Step HCG Pregnancy Test (Strip) – Binic
China Wholesale Covid19 Whatsapp Test Kits Manufacturers Pricelist - One Step HCG Pregnancy Test (Strip) – Binic Detail:
PRINCIPLE OF TEST
One Step hCG Pregnancy Test is a rapid chromatrographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by immersing the test in a urine specimen and observing the formation of pink colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate.
Positive specimens react with the specific antibody-hCG-colored conjugate and form a pink colored line at the test line region of the membrane. Absence of this pink colored line suggests a negative result. To serve as a procedural control, a pink colored line will always appear at the control line region if the test has been performed properly.
TESTING STEPS
Allow the test and the specimen to equilibrate to room temperature (15-30°C) prior to testing.
1.To begin testing, open the sealed pouch by tearing along the notch. Remove the test kit from the pouch and use it as soon as possible.
2.Immerse the strip vertically into the urine sample with the arrow end pointing towards the urine. Do not immerse past the “Mark” Line. Take the strip out after 3 seconds and lay the strip flat on a clean, dry, non-absorbent surface.
3.Wait for pink colored bands to appear. Depending on the concentration of hCG in the test specimen. For all results, wait 5 to 10 minutes to confirm the observation. Do not interpret the result after 30 minutes. It is important that the background is clear before the result is read.
Note: A low hCG concentration might result in a weak line appearing in the test region (T) after an extended period of time; therefore, do not interpret the result after 30 minutes.
The following substances were added in hCG free and 20 mIU/mL spiked samples.
|
luteinizing hormone (LH) |
500mIU/ml |
|
follicle stimulating hormone (FSH) |
1000mIU/ml |
|
thyroid stimulating hormone(TSH) |
1000µIU/ml |
None of the substances at concentration tested interfered with the assay.
INTERFERING SUBSTANCES
The following substances were added in hCG free and 20 mIU/mL spiked samples.
| Hemoglobin | 10 mg/mL |
| bilirubin | 0.06 mg/mL |
| albumin | 100 mg/mL |
None of the substances at concentration tested interfered with the assay.
COMPARISON STUDY
Other commercially available qualitative test kits were used to compare with One Step hCG Pregnancy Test for relative sensitivity and specificity in 201 urine samples. None of samples was discordant, the agreement is 100%.
|
Test |
Predicate Device |
Subtotal |
||
|
+ |
- |
|||
|
AIBO |
+ |
116 |
0 |
116 |
|
- |
0 |
85 |
85 |
|
|
Subtotal |
116 |
85 |
201 |
|
Sensitivity: 100%; Specificity: 100%
Product detail pictures:
Related Product Guide:
Our company has been focusing on brand strategy. Customers' satisfaction is our best advertising. We also supply OEM service for China Wholesale Covid19 Whatsapp Test Kits Manufacturers Pricelist - One Step HCG Pregnancy Test (Strip) – Binic, The product will supply to all over the world, such as: Bahrain, Kyrgyzstan, Cambodia, We have a excellent team supplying professional service, prompt reply, timely delivery, excellent quality and best price to our customers. Satisfaction and good credit to every customer is our priority. We are sincerely looking forward to cooperate with customers all over the world. We believe we can satisfy with you. We also warmly welcome customers to visit our company and purchase our products.
By Julia from India - 2017.08.16 13:39
The company can keep up with the changes in this industry market, product updates fast and the price is cheap, this is our second cooperation, it's good.
By Audrey from The Swiss - 2018.06.03 10:17
