Coronavirus (COVID-19) Rapid Test | https://testcountry.com/products/coronavirus-covid-19-rapid-test

Coronavirus (COVID-19) Rapid Test

Product Description
  • 100 Tests Per Case (10 cases MOQ)
  • Results in 2-5 minutes
  • *Choose Invoice at checkout. Shipping cost will be determined and reflected in invoice, not in checkout
  • Fill out this Order Form to place your order
  • For Professional Use Only: Tests should be conducted by a licensed phlebotomist, or a medical professional
  • Verification of use case prior to shipping is mandatory
  • Purchase Orders / Invoicing available for qualified entities. Please email POs to info@testcountry.com, fill out this Order Form or contact us via chat or phone.
  • Warning: The test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

COVID-19 IgG/IgM Rapid Test Cassette

The test is conducted by taking a small finger-prick blood sample, placing it in the center well of the cassette and then adding two drops of the buffer to the buffer well labeled "B." Results should appear in 3 minutes and are invalid after 10 minutes. For more information, watch our video.

Clinical Evaluation Results:

The clinical evaluation was carried out during February 2020 across 10 hospitals and reported on March 12, 2020. Further clinical evaluations are ongoing and any further information needed can be granted at request.
The results show that the testing reagent and reference reagent have equivalent effectiveness in detecting COVID-19 when tested in the same clinical specimens. Compared with the reference reagent, the positive agreement was 93.87% (95%CI:90.24%~96.46%), the negative agreement was 99.10% (95%CI:97.70%~99.75%) and total agreement was 97.19% (95%CI:95.65%~98.26%). The kappa value of the consistency analysis was 0.94 (95%CI:95.65%~98.26%). The results of the clinical evaluation show that the two reagents (methods) have a high degree of consistency and equivalent sensitivity and specificity in detecting COVID-19.
Coronavirus (COVID-19) rapid test clinical evaluation results
More detailed results of ongoing clinical evaluations and test stability report are available upon request.

Product Facts:

  • Detection Window IgM: Symptomatic 3-5 days, Asymptomatic 7 days
  • Sample: Test can work with whole blood, plasma and serum samples.
  • Storage: The kit can be stored at room temperature or refrigerated (2-30°C).
  • Shelf Life: 24 months from manufacture date
  • More information, such as the product insert, clinical trial results, and CE documentation is available at request

Is the Coronavirus (COVID-19) Rapid Test FDA Approved?

The FDA has allowed the sale and use of these kits in the United States prior to FDA EUA approval, for laboratory and healthcare workers at the point-of-care, during the public health emergency. More information can be found from the FDA here.
While we are working to obtain FDA EUA approval please note:
  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

How Accurate is the Coronavirus (COVID-19) Rapid Test?

Our test has shown in clinical evaluation to have a total agreement of 97.19% and a kappa value of 0.94. Clinical evaluation took place across 10 hospitals in China during February 2020 and included 704 tests. Ongoing clinical evaluation and other information is available upon request. Below is the results of the first clinical evaluation published March 12, 2020. Coronavirus (COVID-19) clinical evaluation results

How Quickly Can the COVID-19 Instant Test Provide Results?

Results are ready within 2-5 minutes, 3 minutes is the suggested waiting time, and are invalid after 10 minutes.

What Causes False Positive or False Negative Results?

False positives are largely attributed to other substances in the blood sample, improper operation especially adding too much sample, and improper reading time.
False negatives are associated with low concentration of antibodies, improper operation especially adding too little specimen, and improper reading time.

What Are the Other Coronavirus (COVID-19) Testing Options?

While our instant tests are useful screening tools for those suspected of being infected with the novel coronavirus, they are to be used in conjunction with other testing methods. The most common of which is the PCR nucleic acid test, which requires a lab, specific testing equipment and a much longer turnaround time.

Instructions:

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 within one hour.
2: Place the test device on a clean and level surface.
3 (For Whole Blood Specimen): Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
3 (For Serum or Plasma Specimens): With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
4:Wait for the colored line(s) to appear. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.

How to read Coronavirus (COVID-19) rapid test results

Interpretation of Results:

Negative: If only the C band is present, the absence of any burgundy color in the both T bands (IgG and IgM) indicates that no anti-COVID-19 antibodies are detected in the specimen. The result is negative.
IgM Positive: In addition to the presence of C band, if only IgM band is developed, the test indicates for the presence of IgM anti-COVID-19 in the specimen. The result is IgM anti-COVID-19 positive.
IgG Positive: In addition to the presence of C band, if only IgG band is developed, the test indicates for the presence of IgG anti-COVID-19 in the specimen. The result is IgG anti-COVID-19 positive.
IgG and IgM Positive: In addition to the presence of C band, both IgG and IgM bands are developed, the test indicates for the presence of both IgG and IgM anti-COVID-19 in the specimen. The result is IgG and IgM anti-COVID-19 positive.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.





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COVID-19 IgG/IgM Rapid Test Cassette

The test is conducted by taking a small finger-prick blood sample, placing it in the center well of the cassette and then adding two drops of the buffer to the buffer well labeled "B." Results should appear in 3 minutes and are invalid after 10 minutes. For more information, watch our video.

Clinical Evaluation Results:

The clinical evaluation was carried out during February 2020 across 10 hospitals and reported on March 12, 2020. Further clinical evaluations are ongoing and any further information needed can be granted at request.
The results show that the testing reagent and reference reagent have equivalent effectiveness in detecting COVID-19 when tested in the same clinical specimens. Compared with the reference reagent, the positive agreement was 93.87% (95%CI:90.24%~96.46%), the negative agreement was 99.10% (95%CI:97.70%~99.75%) and total agreement was 97.19% (95%CI:95.65%~98.26%). The kappa value of the consistency analysis was 0.94 (95%CI:95.65%~98.26%). The results of the clinical evaluation show that the two reagents (methods) have a high degree of consistency and equivalent sensitivity and specificity in detecting COVID-19.
Coronavirus (COVID-19) rapid test clinical evaluation results
More detailed results of ongoing clinical evaluations and test stability report are available upon request.

Product Facts:

  • Detection Window IgM: Symptomatic 3-5 days, Asymptomatic 7 days
  • Sample: Test can work with whole blood, plasma and serum samples.
  • Storage: The kit can be stored at room temperature or refrigerated (2-30°C).
  • Shelf Life: 24 months from manufacture date
  • More information, such as the product insert, clinical trial results, and CE documentation is available at request

Is the Coronavirus (COVID-19) Rapid Test FDA Approved?

The FDA has allowed the sale and use of these kits in the United States prior to FDA EUA approval, for laboratory and healthcare workers at the point-of-care, during the public health emergency. More information can be found from the FDA here.
While we are working to obtain FDA EUA approval please note:
  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

How Accurate is the Coronavirus (COVID-19) Rapid Test?

Our test has shown in clinical evaluation to have a total agreement of 97.19% and a kappa value of 0.94. Clinical evaluation took place across 10 hospitals in China during February 2020 and included 704 tests. Ongoing clinical evaluation and other information is available upon request. Below is the results of the first clinical evaluation published March 12, 2020. Coronavirus (COVID-19) clinical evaluation results

How Quickly Can the COVID-19 Instant Test Provide Results?

Results are ready within 2-5 minutes, 3 minutes is the suggested waiting time, and are invalid after 10 minutes.

What Causes False Positive or False Negative Results?

False positives are largely attributed to other substances in the blood sample, improper operation especially adding too much sample, and improper reading time.
False negatives are associated with low concentration of antibodies, improper operation especially adding too little specimen, and improper reading time.

What Are the Other Coronavirus (COVID-19) Testing Options?

While our instant tests are useful screening tools for those suspected of being infected with the novel coronavirus, they are to be used in conjunction with other testing methods. The most common of which is the PCR nucleic acid test, which requires a lab, specific testing equipment and a much longer turnaround time.

Instructions:

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 within one hour.
2: Place the test device on a clean and level surface.
3 (For Whole Blood Specimen): Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
3 (For Serum or Plasma Specimens): With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
4:Wait for the colored line(s) to appear. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.

How to read Coronavirus (COVID-19) rapid test results

Interpretation of Results:

Negative: If only the C band is present, the absence of any burgundy color in the both T bands (IgG and IgM) indicates that no anti-COVID-19 antibodies are detected in the specimen. The result is negative.
IgM Positive: In addition to the presence of C band, if only IgM band is developed, the test indicates for the presence of IgM anti-COVID-19 in the specimen. The result is IgM anti-COVID-19 positive.
IgG Positive: In addition to the presence of C band, if only IgG band is developed, the test indicates for the presence of IgG anti-COVID-19 in the specimen. The result is IgG anti-COVID-19 positive.
IgG and IgM Positive: In addition to the presence of C band, both IgG and IgM bands are developed, the test indicates for the presence of both IgG and IgM anti-COVID-19 in the specimen. The result is IgG and IgM anti-COVID-19 positive.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.