Convenient Influenza A Rapid Test Detect A Nucleoprotein Antigens Swab Specimen
Convenient Influenza A Rapid Test Detect A Nucleoprotein Antigens Swab Specimen

Convenient Influenza A Rapid Test Detect A Nucleoprotein Antigens Swab Specimen

MOQ:5000pcs
PRODUCT DESCRIPTION
High Light:

infection blood test

,

bacterial infection blood test

Brand Name New Life
Certification ISO13485,CE
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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Convenient Influenza A Rapid Test Detect A Nucleoprotein Antigens Swab Specimen
Convenient Influenza A Rapid Test Detect A Nucleoprotein Antigens Swab Specimen
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

,

bacterial infection blood test

Place of Origin China
Brand Name New Life
Certification ISO13485,CE
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
Category Infectious
Format Strip/cassette
Specimen Swab
Testing time 5-15 minutes
Shelf Life 24 Months
Application influenza A
Accuracy 98.35%

 

Convenient Influenza A Rapid Test Detect A Nucleoprotein Antigens Swab Specimen

Description:

One Step Influenza A Rapid Diagnostic test to detect influenza type A nucleoprotein antigens ,Gold colloidal, quickly
 
 
Intended Use:
 
 
The Influenza A Rapid Test is an in vitro diagnostic test for the qualitative detection of influenza type A nucleoprotein antigens in nasopharyngeal swab and nasal aspirate samples, using the rapid immunochromatographic immunochromatographic method. The identification is based on the monoclonal antibodies specific for the nucleoprotein of Influenza virus A. It will provide information for clinical doctors to prescribe correct medications. Negative results should be confirmed by other methods, such as cell culture.
 
TEST PRINCIPLE
 
The Influenza A Rapid Test Cassette (Swab/Nasal Aspirate) is a qualitative, lateral flow immunoassay for the detection of Influenza A nucleoproteins in nasopharyngeal swab, throat swab or nasal aspirate specimens. In this test, antibody specific to the Influenza A nucleoproteins is separately coated on the test line regions of the test cassette. During testing, the extracted specimen reacts with the antibody to Influenza A that are coated onto particles. The mixture migrates up the membrane to react with the antibody to Influenza A on the membrane and generate one colored lines in the test regions. The presence of this colored line in either or both of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly.
 
 

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

 
TEST PROCEDURE
 
Allow the test, specimen, extraction buffer to equilibrate to 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 assay is performed immediately after opening the foil pouch.
  2.  Place the Extraction Tube in the workstation. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add 10 drops of solution (Approx. 400μl) to the Extraction Tube. See illustration 1.
  3.  Place the swab specimen in the Extraction Tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab. See illustration 2.
  4.  Remove the swab while squeezing the swab head against the inside of the Extraction Tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol. See illustration 3.
  5.  Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. See illustration 4
  6.  Add three drops of the solution (approx.120μl) to the sample well and then start the timer. Read the result at 15 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.
 
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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.
 
 
PERFORMANCE CHARACTERS:
 
Sensitivity, Specificity and Accuracy
 
The Influenza A Rapid Test Cassette (Swab/Nasal Aspirate) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for the Influenza A Rapid Test Cassette (Swab/Nasal Aspirate). Specimens were considered positive if RT-PCR indicated a positive result. Specimens were considered negative if RT-PCR indicated a negative result
 
Nasopharyngeal Swab Specimen
 

 Type A
RT-PCRTotal
PositiveNegative
AllTest Flu APositive15116
Negative199100
Total16100116
Relative Sensitivity93.8%
Relative Specificity99.0%
Accuracy98.3%

 
Throat Swab Specimen
 

 Type A
RT-PCRTotal
PositiveNegative
AllTest Flu APositive9211
Negative1105106
Total10107117
Relative Sensitivity90.0%
Relative Specificity98.1%
Accuracy97.4%

 
Nasal Aspirate Specimen
 

 Type A
RT-PCRTotal
PositiveNegative
AllTest Flu APositive516
Negative08989
Total59095
Relative Sensitivity100%
Relative Specificity98.9%
Accuracy98.9%

 
Reactivity with Human Influenza Strain
 
Detection Range:Minimal detection limit for Flu A is 3.0×104 TCID50 / Test.
 
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.
 

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