For Professional Use Only
On 3/23/2020, FDA provided EUA number #200056 for the EUA application of our device: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma).
On 5/29/2020, The test has been authorized by the FDA under an EUA for use by authorized laboratories. We are affiliated with a moderate/high complexity lab. The lab interprets the results for validation.
In compliance with the FDA guidelines, all tests will have a notice that the test has not been FDA cleared or approved. 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. Please get PCR-nasal test for confirmation.
The COVID-19 RT-PCR test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasal, nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals suspected of COVID-19 by their healthcare provider.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Testing with the COVID-19 RT-PCR test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The COVID-19 RT-PCR is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Detection of IgG antibodies may indicate exposure to SARS-CoV-2 (COVID-19). It usually takes at least 10days after symptom onset for IgG to reach detectable levels. An IgG positive result may suggest an immune response to a primary infection with SARS-CoV-2, but the relationship between IgG positivity and immunity to SARS-CoV-2 has not yet been firmly established. Antibody tests have not been shown to definitively diagnose or exclude SARS-CoV-2 infection. Diagnosis of COVID-19 is made by detection of SARS-CoV-2 RNA by molecular testing methods, consistent with a patient’s clinical findings.
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 could also be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. This test is not to be used for the screening of donated blood.
The Roche Elecsys Anti-SARS-CoV-2 antibody test is designed to identify mature, high affinity antibodies, significantly reducing the chance of a false positive result. It provides 99.8 percent specificity, which is greater than previously available antibody tests.
The Roche Elecsys Anti-SARS-CoV-2 immunoassay is authorized for the detection of antibodies to SARS-CoV-2 in human serum or plasma. This test measures human SARS-CoV-2 antibodies that are generated as part of the initial immune response and adaptive human immune response to the virus and is to be performed only using serum or plasma specimens.
The Elecsys Anti-SARS-CoV-2 immunoassay can be used to test human serum or plasma (Heparin, EDTA).
The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA200514/A001). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.
Serological tests for SARS-CoV-2 are intended for individuals who may have been exposed to COVID-19, whether they are symptomatic or not. It has been shown to be effective in identifying silent carriers when coupled with rapid viral testing in IgM positive individuals. Understanding if an individual has developed antibodies and a potential immune response can be useful in the determination of important decisions such as the ability for business to monitor their staff during economic reopening across the country.
Employers can ask employees to provide the following information:
- A positive result for, or other diagnosis with, COVID-19;
- Symptoms of infection with COVID-19, e.g., fever of or over 100.4°F, cough, shortness of breath, sore throat;
- “Close contact” (as defined by the Centers for Disease Control) with any person who has tested positive for, or has otherwise been diagnosed with, COVID-19 infection within the preceding 14 days;
- Whether the employee has been asked to self-quarantine by a health official within the preceding 14 days;
- Whether the employee has traveled to, or stopped over in, a country for which the CDC has issued a Level 3 travel health notice; and
- Depending on geographic location, whether the employee is considered “high risk” for COVID-19 infection, meaning over age 60, pregnant, or suffering from diabetes, lung disease, heart disease, asthma, HIV, or similar conditions.
Employers may be able to require employees to be tested if they have symptoms of COVID-19 and, nonetheless, assert that they are fit for work.
Yes. However, employers should implement a temperature check protocol to ensure that temperature checks are designed to reduce the threat that an employee with COVID-19 poses to the workplace. Temperature checks should be reliable, effective, performed consistently, and respect employees’ privacy. For example, all employees entering facilities should be checked only by trained personnel and the results should be treated as confidential.
Generally, no. HIPAA imposes obligations to safeguard protected health information (PHI) only on covered entities, which are defined to include health plans, health care clearinghouses, and health care providers. An employer acting in its capacity as an employer is not subject to HIPAA. Other laws, such as the Americans with Disabilities Act (ADA) or state confidentiality laws, may apply.
No. The ADA prohibits such a disclosure. However, the employer can provide co-workers with information that would help them evaluate the risk of infection.
Covid-19 health care costs are covered by health insurance carriers. A doctor’s visit is necessary for the claim to be filed and paid. The POC test (Nasal or oral swap) is covered. Rapid antibody tests are currently covered if they are performed by a CLIA (certified lab) testing facility. Rapid antibody testing is used for a mass pre-screening and is not diagnostic or giving medical advise. The test is only intended for informational purpose and is the participant’s responsibility to seek medical care pending test outcome.
Fill out the form below to submit a request to purchase COVID-19 test kits. Test kits will be fulfilled on a first-come, first-serve basis based on supplies available.