Embryonic Stem Cells

NIDS® COVID-19 Antigen Rapid Test

For Investigational and Surveillance Use Only

INTRODUCTION:

SARS-CoV-2 (with the disease referred to as COVID-19), was first reported in December 2019. This virus, which causes COVID-19, in addition to SARS and MERS, is among the top three deadly coronaviruses known to man.  SARS-CoV-2 is an enveloped, single-stranded RNA virus of the β genus. The virus can trigger mild to severe respiratory illness and has spread rapidly worldwide. The median incubation time of this virus is about 5 days with symptoms manifestation within 14 days of infection. Some of the symptoms of COVID-19 may include fever, cough, shortness of breath, and loss of taste or smell, among others.

 

The NIDS COVID-19 Antigen Rapid Test Kit is a rapid lateral flow immunoassay for the qualitative detection of SARS-CoV-2 from direct nasal swabs using NIDS Swab Buffer. The test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The Kit contains all components required to carry out a test for SARS-CoV-2.

The NIDS COVID-19 Antigen Rapid Test uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein in nasal swab specimens. SARS-CoV-2-specific antibodies and a control antibody are immobilized onto a support membrane and combined with other reagents and pads to construct the test strip. This test strip, and a sample well to receive the liquid swab specimen, are housed within a plastic test device case.

 

To perform the test, a nasal swab patient specimen is immersed in NIDS Antigen swab buffer to extract the nucleocapsid protein from the virus. The sample mixture is dispensed into the sample well of the device, ­­ and test results are interpreted visually at 15 minutes based on the presence or absence of pink/purple-colored lines. Please see the Quick Reference Guide Instructions:

 

 

INTENDED USE:

The NIDS COVID-19 Antigen Rapid Test Kit is a lateral flow immunoassay (LFI) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct mid-turbinate (MT) nasal swabs from individuals who are suspected of having COVID-19 by their healthcare provider within the first seven (7) days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate complexity, high complexity, or waived tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation. For more information, please see the Instructions For Use here: 

 

 

 

 

The NIDS COVID-19 Antigen Rapid Test Kit does not differentiate between SARS-CoV and SARS-CoV-2.

 

Results are for the identification of SARS-CoV-2 nucleocapsid protein. Antigen is generally detectable in MT nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigen, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Additional confirmatory testing with a molecular test for positive results may be necessary for results with and without serial testing, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

 

Negative results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.  Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection.

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