Wholesale Price Covid 19 Test Kit Home - One Step HCG Pregnancy Test (Strip) – Binic
Wholesale Price Covid 19 Test Kit Home - 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%
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Our eternal pursuits are the attitude of "regard the market, regard the custom, regard the science" as well as the theory of "quality the basic, have confidence in the very first and management the advanced" for Wholesale Price Covid 19 Test Kit Home - One Step HCG Pregnancy Test (Strip) – Binic, The product will supply to all over the world, such as: Bahrain, Russia, Italy, So far our merchandise have been exported to east Europe, the Middle East, Southeast, Africa and South America etc. We have now 13years experienced sales and purchase in Isuzu parts at home and abroad and the ownership of the modernized electronic Isuzu parts checking systems. We honor our core principal of Honesty in business, priority in service and will do our best to provide our customers with high quality items and excellent service.
By Quintina from Serbia - 2018.06.21 17:11
Staff is skilled, well-equipped, process is specification, products meet the requirements and delivery is guaranteed, a best partner!
By Rosalind from USA - 2017.08.16 13:39
