SARS-CoV-2 lgM/lgG ANTIBODY Point of Care Test Kit – Single Cassette

$29.95

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

IMPORTANT INFORMATION ABOUT THIS TEST

Please review carefully before administering the test.

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 enclosed Clinical Examination Results Sheet for a more detailed description of the study and its results.) The clinical study resulted in the following validation data:

 

Sensitivity: 97.5%

Specificity: 99.5%

Positive Predictive Value (PPV): 97.5%

Negative Predictive Value (NPV): 99.5%

Accuracy: 99.1%

 

Despite the study’s overall accuracy, your test results may be inaccurate due to improper use, failure to follow the POC testing procedure as directed, or other limitations 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.

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 review 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 antibody 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 result 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.

THIS TEST HAS NOT BEEN REVIEWED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA). Based on the FDA’s most recent publications relating to Emergency Use Authorization (EUA) issued on February 29, 2020 and updated March 16, 2020, the EUA does not apply to POC testing for SARS-CoV-2.

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 POC 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.

Category:

COLLOIDAL GOLD METHOD

Limitations

  • IgG and lgM antibodies to 2019 Novel Coronavirus can be detected with two to three weeks after exposure. lgG remains positive, but the antibody level drops overtime.
  • Testsea COVID-19 IgM and IgG Antibody Test has a 95% detection rate as reported by First Affiliated Hospital of Anhui Medical University.

As with all diagnostic tests, all results must be considered with other clinical information available to the physician. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of SARS-CoV-2 infection.

Storage and Stability

Store as packaged in the sealed pouch at room temperature or refrigerated (4-30℃ or 40-86℉). The test device is stable through the expiration date printed on the sealed pouch.

The test must remain in the sealed pouch until use.

DO NOT FREEZE.

Do not use beyond the expiration date.

Test cassette is stable for 12 months from the date of production when stored properly in unopened aluminum foil pouches with desiccant.

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

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