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 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.

 

 

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 nasal swabs from individuals suspected of COVID-19. It is currently intended for Investigational and surveillance use only, especially within the first seven (7) days of symptom onset.

 

The NIDS COVID-19 Antigen Rapid Test Kit does not differentiate between SARS-CoV-1 and SARS-CoV-2.

 

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, 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. The agent detected may not be the definite cause of disease.

 

Negative results from patients with symptom onset beyond seven days should be treated as presumptive, and, if necessary, for patient management purposes, confirmation with a molecular assay may be performed. 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 those regarding infection control. 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.

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ANP Technologies®, Inc.