BioHit SARS-CoV-2 Antigen Rapid Test Kit

 

Category:
TEST OVERVIEW

This test was manufactured by BioHit Healthcare (Hefei) Co., Ltd. for in vitro detection of the antibodies associated with SARS-CoV-2, the virus causing coronavirus disease 2019 (“COVID-19”). In response to SARS-CoV-2 infection, your body produces specific immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies. This test is designed to confirm the presence of IgM and/or IgG antibodies in your blood. A study of 226 samples from BioHit Healthcare (Hefei) Co., Ltd has shown the test to be relatively precise in detecting the presence of IgM and/or IgG antibodies based on a clinical experiment conducted under strict controls and designed with blinded and controlled features. (Please see the en- closed Clinical Examination Results Sheet for a more detailed description of the study and its results.) The clinical study resulted in the following validation data: 

Despite the study’s overall accuracy, your test results may be inaccurate due to improper use, failure to follow the testing procedure as directed, or other lim- itations unrelated to test performance. This may result in a false positive, false negative, or an invalid result. In addition, there are risks associated with the test, including but not limited to bleeding, exposure to blood borne pathogens, hematoma, and infection, especially if proper hand-washing and sanitation measures are not followed. Please carefully review and follow all enclosed test procedures. Please consult with a healthcare provider before administering the test for any pediatric patient.

  • Sensitivity: 97.5%
  • Specificity: 99.5%
  • Positive Predictive Val- ue (PPV): 97.5%
  • Negative Predictive Val- ue (NPV): 99.5%
  • Accuracy: 99.1%

THIS IS NOT A DIAGNOSTIC TEST

This is a screening test only and may be used for the qualitative detection of the presence of IgM and/or IgG antibody to SARS-CoV-2 in blood. Please carefully re- view the following information relating to the test results.

Positive Test Results. A positive test result is not a clinical diagnosis of a SARS-CoV-2 infection or COVID-19. 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. Results from anti- body testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. A COVID-19 diagnosis can only be made by a medical professional in conjunction with an evaluation of any signs and symptoms of the disease and a history of possible exposure to the virus. If you obtain a positive result from this test, please consult with your local or state health authorities for further validation and recommendations. Depending on your symptoms, you may be advised to go to the emergency room or self-quarantine at home.

Negative Test Results. A negative test results does not rule out the possibility of a SARS-CoV-2 infection or the development of COVID-19. The sensitivity of this test depends on the concentration of IgG and/or IgM antibody to SARS-CoV-2 in the sample. Therefore, test samples with low antibody concentration may show negative results despite the possible presence of SARS-CoV-2. 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. In addition, if you have a negative test result, but have symptoms associated with COVID-19, please consult with your local or state health authorities for further testing and recommendations.

COVID-19 Symptoms. Regardless of the results of this test, you are advised to carefully monitor your health and physical symptoms. The common symptoms of COVID-19 are fever, cough, polypnea (rapid breathing, panting), anhelation (shortness of breath), and difficulty breathing. In more serious cases, infection may cause pneumonia, severe acute respiratory syndrome, renal failure, and even death. In accordance with guidance from the CDC, mildly ill patients may be encouraged to stay

home and contact their healthcare provider by phone for guidance about clinical management. Patients who have severe symptoms, such as difficulty breathing, should seek care immediately. Older patients and individuals who have underlying medical conditions or are immunocompromised should contact their physician early in the course of even mild illness.

According to its published guidelines, the FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection and has encouraged developers to discuss their validation for self-collection tests with the FDA.

While the FDA does not yet have a BioHit has provided information policy for testing of SARS-CoV-2, about this test, including test development, validity, efficacy, sensitivity, and test limitations, to the FDA and will work closely with the FDA throughout any future authorization process.

Serial number

Days from onset

Number of antigen positive samples

Total number of samples

Sensitivity

1

0-3

27

29

93.10%95CI:77.23%~99.15%

2

4-7

33

33

100%95CI:89.42%100.00%

Total

≤7

60

62

96.77%95CI:88.83%~99.61%

  • Sample source: The samples were collected from 62 patients covid-19 confirmed by PCR

No

Number of antigennegative

samples

Total number of samples

Specificity

1

186

188

98.9%95CI96.21%99.87%

  • Sample source: The 188samples were confirmed negative by PCR.

COVID-19 patients 

Nucleic acid detection in nasopharyngeal swab

Antigen detection 

in serum

Nucleic acid detection in sputum

62

60.78%

96.77%

100%

  • The whole course blood detection of SARS-CoV-2 has excellent sensitivity andspecificity, which can meet thedemand of clinical detection.
  • The test results have guiding significance for the selection of clinical treatment plan.
  • It is easy to operate, and is expected to be used in population screening and follow-up, and blocking the propagation path.

FDA Disclaimer: 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.Not for the screening of donated blood.

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BioHit SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)

Test kits in stock and ship directly from our Allentown, PA and Charlotte, NC facilities.

$499.98

FOR ORDERS OVER 500 (20 kits), PLEASE CONTACT US FOR VOLUME PRICING

Limit of Detection : 20 TCID50/ml

Submission Number: PEUA201865

Pack Includes 25ea full test kits.

IMPORTANT INFORMATION ABOUT THIS TEST

Please review carefully before administering the test.

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