China Wholesale Test Virus Detection Kit Factory Suppliers - One Step hCG Pregnancy Test (Cassette) – Binic

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China Wholesale Test Virus Detection Kit Factory Suppliers - One Step hCG Pregnancy Test (Cassette) – 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 adding urine specimen to the specimen well of the test device 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

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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.Draw the urine sample using the pipette provided, and dispense 3-4 drops (200 µL) onto the sample well of the cassette (see diagram).

3.Wait for the pink colored bands to appear. Depending on the concentration of hCG. 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.

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:

China Wholesale Test Virus Detection Kit Factory Suppliers - One Step hCG Pregnancy Test (Cassette) – Binic detail pictures

China Wholesale Test Virus Detection Kit Factory Suppliers - One Step hCG Pregnancy Test (Cassette) – Binic detail pictures

China Wholesale Test Virus Detection Kit Factory Suppliers - One Step hCG Pregnancy Test (Cassette) – Binic detail pictures

China Wholesale Test Virus Detection Kit Factory Suppliers - One Step hCG Pregnancy Test (Cassette) – Binic detail pictures


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We've got a specialist, effectiveness staff to supply high quality service for our shopper. We always follow the tenet of customer-oriented, details-focused for China Wholesale Test Virus Detection Kit Factory Suppliers - One Step hCG Pregnancy Test (Cassette) – Binic, The product will supply to all over the world, such as: Bandung, Guyana, Croatia, We follow up the career and aspiration of our elder generation, and we are eager to open up a new prospect in this field, We insist on "Integrity, Profession, Win-win Cooperation", because we have a strong backup, that are excellent partners with advanced manufacturing lines, abundant technical strength, standard inspection system and good production capacity.
  • The goods we received and the sample sales staff display to us have the same quality, it is really a creditable manufacturer.
    5 Stars By Matthew from Mexico - 2018.10.31 10:02
    We always believe that the details decides the company's product quality, in this respect, the company conform our requirements and the goods are meet our expectations.
    5 Stars By Queena from Peru - 2018.02.04 14:13

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