NIDS® COVID-19 Antigen Rapid Test
NEW PRODUCT | FDA EUA
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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.
WOW!: 95.1% sensitivity | 97% specificity
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.
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., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. For more information, please see the documents provided below:
INSTRUCTIONS FOR USE
PATIENT FACT SHEET
HEALTH CARE PROVIDER FACT SHEET
QUICK REFERENCE
EXTERNAL CONTROL KIT
FDA EUA AUTHORIZATION
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