One Step high accuracy  Strep A Rapid Diagnostic test , quick and easily operation, Swab specimen,gold collidal method
One Step high accuracy  Strep A Rapid Diagnostic test , quick and easily operation, Swab specimen,gold collidal method
One Step high accuracy  Strep A Rapid Diagnostic test , quick and easily operation, Swab specimen,gold collidal method

One Step high accuracy Strep A Rapid Diagnostic test , quick and easily operation, Swab specimen,gold collidal method

MOQ:5000pcs
PRODUCT DESCRIPTION
High Light:

infection blood test

,

home blood test kit

Brand Name New Life
Certification ISO13485,
Delivery Time 20-30days
Minimum Order Quantity 5000pcs
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ABOUT US
Orient New Life Medical Co.,Ltd.
Orient New Life Medical Co.,Ltd. manufacturer profile
12F,Guting Building,Hefeng Creative Square,No.495 Jiangdong North Road,Ningbo,Zhejiang, China ,China
5.0
Verified Supplier
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One Step high accuracy  Strep A Rapid Diagnostic test , quick and easily operation, Swab specimen,gold collidal method
One Step high accuracy Strep A Rapid Diagnostic test , quick and easily operation, Swab specimen,gold collidal method
MOQ: 5000pcs
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About Us
Orient New Life Medical Co.,Ltd.
Orient New Life Medical Co.,Ltd. manufacturer profile
12F,Guting Building,Hefeng Creative Square,No.495 Jiangdong North Road,Ningbo,Zhejiang, China ,China
5.0
Verified Supplier
Company Name Orient New Life Medical Co.,Ltd.
Business Type: Manufacturer,Exporter
Brands: New Life
No. of Employees: 200~300
Year Established: 2009
Annual Sales: 10,000,000-15,000,000
Company Location 12F,Guting Building,Hefeng Creative Square,No.495 Jiangdong North Road,Ningbo,Zhejiang, China
Factory Location No.1369, Chengnan Road, Jiaxing, Zhejiang, China
China Orient New Life Medical Co.,Ltd. manufacturer profile
China Orient New Life Medical Co.,Ltd. manufacturer profile
China Orient New Life Medical Co.,Ltd. manufacturer profile

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

 

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

 

Company's core technical team with more than 35 employees,3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.

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PRODUCT DESCRIPTION
High Light:

infection blood test

,

home blood test kit

Place of Origin China
Brand Name New Life
Certification ISO13485,
Model Number Cassette
Minimum Order Quantity 5000pcs
Packaging Details 1pc/pouch, 25pcs/box
Delivery Time 20-30days
Payment Terms T/T, Western Union, MoneyGram
Supply Ability 2000000pcs/month
Classification Infectious
Format Strip/cassette
Specimen Whole Blood/Serum/Plasma
Testing time 5-15 minutes
Shelf Life 24 Months
Application Strep A Ag
Specialty 97.89%

 

One Step high accuracy Strep A Rapid Diagnostic test , quick and easily operation, Swab specimen,gold collidal method

Description:

One Step high accuracy Strep A Rapid Diagnostic test , quick and easily operation, Swab specimen,gold collidal method

 

Product Name: One Step Strep A Rapid Diagnostic test cassette

 

Accessories:

 

Test Cassettes Sterilized Swabs Sample Extraction Buffer
Tube Tips Workstation Package Insert
Extraction Tubes    

 

 

Intended Use:

 

 

The Strep A Rapid Test Dipstick is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigens from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.

 

Summary:

 

Streptococcus pyogenes is non-motile gram-positive cocci, which contains the Lancefield group A antigens that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis.1 Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess.2 Traditional identification procedures for Group A Streptococci infection involve the isolation and identification of viable organisms using techniques that require 24 to 48 hours or longer.3.4 The Strep A Rapid Test Cassette is a rapid test to qualitatively detect the presence of Strep A antigens in throat swab specimens, providing results within 5 minutes. The test utilizes antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigens in a throat swab specimen.

 

TEST PRINCIPLE

 

The Strep A Rapid Test Cassette a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of the test. During testing, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. The mixture migrates up the membrane to react with the antibody to Strep A on the membrane and generate a color line in the test line region. The presence of this color line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

 

TEST PROCEDURE

 

Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.

  1.  Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
  2.  Hold the Extraction Reagent 1 bottle vertically and add 4 full drops (approximately 240 μl) of Extraction Reagent 1 to an extraction tube. Extraction Reagent 1 is red in color. Hold the Extraction Reagent 2 bottle vertically and add 4 full drops (approximately 160 μl) to the tube. Extraction Reagent 2 is colorless. Mix the solution by gently swirling the extraction tube. The addition of Extraction Reagent 2 to Extraction Reagent 1 changes the color of the solution from red to yellow.
  3.  Immediately add the swab into the extraction tube, agitate the swab vigorously 15 times, leave the swab in the extraction test tube for2 minutes.
  4.  Press the swab against the side of the tube and squeeze the bottom of the tube while removing the swab so that most of the liquid stays in the tube. Discard the swab.
  5.  Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface.
  6.  Add 3 full drops of the extracted solution (approx. 150μl) to the specimen well of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well.Wait for the color to appear. Read the result at 10 minutes; do not interpret the result after 20 minutes.

 

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

 

INTERPRETATION OF RESULTS

 

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

 

Negative:

The control line appears in the result window, but the test line is not visible.

 

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

 

 

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PERFORMANCE CHARACTERS:

 

Clinical Study

 

Using three medical centers for evaluation, a total of 526 throat swabs were collected from patients exhibiting symptoms of pharyngitis. Each swab was rolled onto a sheep blood agar plate, and then tested by the Strep A Rapid Test Cassette (Throat Swab). The plates were further streaked for isolation, and then incubated at 37℃ with 5-10% CO2 and a Bacitracin disk for 18-24 hours. The negative culture plates were incubated for an additional 18-24 hours. Possible GAS colonies were subcultured and confirmed with a commercially available latex agglutination grouping kit. Of the 525 total specimens, 401 were confirmed to be negative and 124 were confirmed to be positive by culture. During this study, one Strep F specimens yielded positive results with the Test. One of these specimens was re-cultured, then re-tested and yielded a negative result. Three additional different Strep F strains were cultured and tested for cross-reactivity and also yielded negative results.

 

Method Culture Total Results
Strep A Rapid Test Cassette Results Positive Negative
Positive 100 8 108
Negative 5 350 355
Total Results 105 358 463

 

Relative Sensitivity: 95.2% (95%CI:*89.6%-98.2%)

 

Relative Specificity: 97.8% (95%CI:*95.8%-99.0%)

 

Overall accuracy: 97.2% (95%CI:*95.3%-98.4%) *Confidence Intervals

 

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

 

 
ORIENT NEW LIFE MEDICAL CO., LTD.
Contact: Jerry Meng
Email: Jerry @ newlifebiotest .com
Tel. +86 18657312116
SKYPE enetjerry
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