Healthcare services, government agencies, and essential services are given first priority.
The BIOHIT test kit is a lateral-flow assay which uses colloidal gold SARS-CoV-2 recombinant antigen-antibody complexes to identify IgG/IgM Antibodies in the blood. IgM (acute stage) and IgG (recovery stage) antibodies are generated by the body in response to a viral infection such as the one caused by COVID-19. Lateral flow is an inexpensive, reliable, and fast way to detect specific molecules in the body. Additionally, the tests are extremely easy to interpret and do not require complex and expensive machinery. Biohit’s test kits were validated in a Yale lab and found to have a sensitivity of 94.9% and a specificity of 98.8%. Additional supporting data is also available from the National Cancer Institute.
- Not for Personal Use
- Available for Healthcare Professionals & Labs Only
- FDA EUA letter of authorization
- COVID-19 BIOHIT Test Kit Brochure
- COVID-19 BIOHIT Test Kit – Instructions for Use
- Sensitivity: 97.5%
- Specificity: 99.5%
- Positive Predictive Val- ue (PPV): 97.5%
- Negative Predictive Val- ue (NPV): 99.5%
- Accuracy: 99.1%
- Results in 15 minutes
- CE certified, NCI validated, FDA EUA authorized
- 25 tests/box
BIOHIT test kit availability and pricing is in constant flux due to the current COVID-19 pandemic demands. Pricing and availability may change from our site listing but will be confirmed for each order.
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. Fol- low-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.
COLLOIDAL GOLD METHOD
- IgG and lgM antibodies to 2019 Novel Coronavirus can be detected with 2-3 weeks after exposure. lgG remains positive, but the antibody level drops overtime.
- Testsea COVID-19 IgM and IgG antibody Rapid 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 followup 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.