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In Vitro Pregnancy Rapid Test Kit

China Newscen Biopharm Co., Limited certification
China Newscen Biopharm Co., Limited certification
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In Vitro Pregnancy Rapid Test Kit

In Vitro Pregnancy Rapid Test Kit
In Vitro Pregnancy Rapid Test Kit In Vitro Pregnancy Rapid Test Kit In Vitro Pregnancy Rapid Test Kit In Vitro Pregnancy Rapid Test Kit

Large Image :  In Vitro Pregnancy Rapid Test Kit

Product Details:
Place of Origin: China
Brand Name: Newscen
Certification: ISO9001, CE, TUV, FDA
Model Number: HCG
Payment & Shipping Terms:
Minimum Order Quantity: 10 Boxes or 400 Kits (40 Kits/Box)
Price: Negotiable as per Order Quantity
Packaging Details: 40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm
Delivery Time: 8 days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 50,000 Kits Per Day
Detailed Product Description
Methodology: Colloidal Gold Format: Cassette / Strip
Result Time: Read In 20 Minutes Usage: For In Vitro Diagnostic Use Only
Manufacturer/Trader: Manufacturer OEM/ODM: Acceptable
High Light:

HCG Pregnancy Rapid Test Kit

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In Vitro Pregnancy Rapid Test Kit

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25mIU/ml Pregnancy Rapid Test Kit

Human Chorionic Gonadotropin (HCG) Tests (Pregnancy tests)
 
HCG Rapid Diagnostic Kit Pregnancy Test Fast Urine Detection Cassette In Vitro Test Colloidal Gold
 

Intended Use

 

Human Chorionic Gonadotropin (HCG) tests are single use, rapid immunoassay for in vitro qualitative determination of human chorionic gonadotropin (HCG) in urine to aid in the early detection of pregnancy. It is intended for use by the lay users.

 

In Vitro Pregnancy Rapid Test Kit 0

 

Principle

 

Antibodies to HCG are precoated onto membrane as a capture reagent on the test zone. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with antibodies to HCG. If HCG is present, a red colored line will develop on the membrane in proportion to the amount of HCG present in the specimen. To serve as a procedural control, red colored line in the control zone will always appear regardless of the presence of HCG.

 

In normal pregnancy, HCG can be detected in urine after fertilization. Usually, concentration of HCG in urine is at least 25mIU/ml as early as seven to ten days after conception. The concentration increases steadily and reaches its maximum between the eighth and eleventh weeks of pregnancy.

 

The appearance of HCG soon after conception and its subsequent rise in concentration during early gestational growth make it an excellent marker for the early detection of pregnancy
 

In Vitro Pregnancy Rapid Test Kit 1

 

Reagents and Materials Provided

 

Each kit contains:

 

☀ Each pouch contains one cassette with one desiccant bag

☀ Instruction for use

☀ Urine cup

☀ Disposable plastic dropper

 

Materials Required But Not Provided

 

Timer or stopwatch

 

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Sample Collection and Test Preparation

 

☀ First morning urine typically contains the highest concentration of HCG and is therefore the best sample for performing the urine test. However, any urine specimen may be used.

 

☀ Collect the urine specimen in a clean container. Do not use preservatives.

 

☀ If the specimen is not used immediately following collection, but is to be used within 48 hours it should be refrigerated (2 to 8℃), and brought back to room temperature before testing. If the specimen is not going to be used for more than 48 hours, it should be frozen at -20℃. A frozen specimen should not be used if stored longer than 2 weeks. Prior to testing, the frozen specimen must be completely thawed, thoroughly mixed, and brought to room temperature.

 

☀ Urine samples exhibiting visible precipitates should be filtered, centrifuged, or allowed to settle and clear aliquots obtained for testing.

 

Assay Procedure

 

Allow the test, urine specimen and/or controls to reach room temperature prior to testing.

 

☀ Before opening, allow the test cassette to reach room temperature. Use it immediately after opening.

 

☀ Place the test cassette on a dry, clean, non-absorbent flat surface, add 2-3 drops of urine into Sample well, and start the timer and wait for the colored line(s) to appear.

 

☀ Read results at 1-5 minutes. Do not interpret the result after 10 minutes.

 

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Interpretation of Results
 
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Negative: No red lines appear within 10 minutes in the test zone (T), only a red line in the control zone (C), which this indicates that the specimen does not contain a detectable level of HCG.

 

Positive: One red line in the control zone (C) and one red line in the test zone (T). This indicates the specimen contains HCG.

 

Invalid: If no red lines appear, the test is invalid. Discard the test and repeat with new specimen and new cassette.

 

Built-In Control

 

Human Chorionic Gonadotropin (HCG) tests have a built in procedural control that demonstrates assay validity. A red line appearing adjacent to the control zone (C) indicates that the test runs correctly.

 

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Storage

 

Human Chorionic Gonadotropin (HCG) tests should be stored at room temperature (4-30℃, do not freeze) for 24 months from the date of manufacture. Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, perform the test as early as possible (within 1 hour) to avoid test cassette from becoming moist.

 
Precision
 
Intra-assay: The test strips of the same lot number were used in the specimens containing 25mIU/mL hCG. Results and color are consistent.
 
Inter-assay: Three lots of test strips were used in specimens containing 25mIU/mL hCG. Results and color are consistent.
 
Clinical Study
 
The study included 80 positive and 120 negative patient urine specimens confirmed by routine diagnostic method and tested by pregnancy test strip. The results showed 100% consistency.
 

 

In Vitro Pregnancy Rapid Test Kit 6

 

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Contact Details
Newscen Biopharm Co., Limited

Contact Person: Mr. Randy.Zhang

Tel: 008618611273771

Send your inquiry directly to us (0 / 3000)