China Wholesale Water Bacteria Test Kit Quotes Manufacturer - One Step HCG Pregnancy Test (Strip) – Binic
China Wholesale Water Bacteria Test Kit Quotes Manufacturer - 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 solutions are widely regarded and trustworthy by consumers and may meet continually modifying financial and social requirements for China Wholesale Water Bacteria Test Kit Quotes Manufacturer - One Step HCG Pregnancy Test (Strip) – Binic, The product will supply to all over the world, such as: Lithuania, Argentina, New Zealand, We adopt advanced production equipment and technology, and perfect testing equipment and methods to ensure our product quality. With our high-level talents, scientific management, excellent teams, and attentive service, our merchandise are favored by domestic and foreign customers. With your support, we'll build a better tomorrow!
By Afra from Rwanda - 2018.06.30 17:29
The factory technical staff not only have high level of technology, their English level is also very good, this is a great help to technology communication.
By Ryan from Tunisia - 2018.12.25 12:43
