Testsealabs COVID-19 Neutralizing antibody Test

Short Description:

The SARS-CoV-2 Neutralising Antibody Test Cassette is a rapid chromatographic immunoassay for the semi-quantitative detection of neutralising antibodies to 2019 coronavirus disease in human whole blood 、 Serum or Plasma as an aid to the assessment of human neutralising antibody titres against novel coronaviruses


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Specimen Collection And Preparation

1.The SARS-CoV-2 Neutralizing antibody Test Cassette is intended for use with human wholeblood, serum or plasma specimens only.
2.Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
3.Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, serum or plasma specimens should be kept below-20°C.Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days after collection.Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
4.Containers containing anticoagulants such as EDTA,citrate,or heparin should be used for whole blood storage.Bring specimens to room temperature prior to testing.
5.Frozen specimens must be completely thawed and mixed well prior to testing.Avoid repeated freezing and thawing of specimens.
6. If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
7.Icteric,lipemic,hemolyzed,heat treated and contaminated sera may cause erroneous results.
8.When collecting finger stick blood with a lancet and alcohol pad,Please discard the first drop of whole blood.

Materials

Materials provided
● Test Devices
● Buffer
● Alcohol pad Lancets
● Disposable plastic pipette
● Package insert

Materials required but not provided
● Specimen collection containers Centrifuge (for plasma only)
● Micropipette(for serum/Plasma)
● Timer

Directions For Use

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1.Bring the pouch to room temperature before opening.Remove the test device from the sealed pouch and use it as soon as possible.
2.Place the test device on a clean and levelsurface. For Serum or Plasma Specimens: Using the Micropipette,and transfer 10ul serum/plasma to the specimen well of the test device,then add 2 drop of buffer,and start the timer.For Whole Blood (Venipuncture/Fingerstick) Specimens: Using the provided disposable pipette,and transfer 10ul whole blood to the specimen well of the test device,then add 2 drop of buffer, and start the timer. Note: Specimens can also be applied using a micropipette.
3. Wait for the colored line(s) to appear.Read results at 15 minutes.Do not interpret the result after 20 minutes.

Performance Characteristics

Sensitivity and Specificity

The SARS-CoV-2 Neutralizing antibody Test Cassette has been compared to a leading commercial testing using clinical specimens from Naturally infected patients

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The sensitivity of SARS-CoV-2 Neutralizing antibody Test Cassette is 97.73%, that is to say, 97 out of 100 patients can be detected as positive patients, and the other 3 are false negative, that is to say, there is a 3% probability of false negative.
The specificity of SARS-CoV-2 Neutralizing antibody Test Cassette is 100%, that is to say, 100 of 100 healthy people can be detected as negative patients, and the other 1 are false positive, that is to say, there is a 1% probability of false positive.

Cross-reactivity
The SARS-CoV-2 Neutralizing antibody Test Cassette has been tested for anti-influenza A virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis, anti-HIV anti-rheumatoid factor, anti-M. Pneumonia, anti-Chlamydiapneumoniae and anti- HCV positive specimens. The results showed no cross- reactivity.The results show cross-reactivity to anti-SARS-CoV-1 positive samples.


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