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Rapid Antigen Immunoassay Screen /Nasal to detect SARS-CoV-2

Rapid Antigen  Immunoassay Screen /Nasal to detect SARS-CoV-2
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Nasal swab to detect, defend & defeat Covid 19
First Sign   SARS-CoV-2 Antigen Nasal Swab Screen

The First Sign  SARS-CoV-2 Antigen screen is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly collected from individuals suspected of COVID 19 by their healthcare provider within five days of symptom onset 

This test has been authorized for use at the POC (Point of Care)  for those that meet the requirements to perform moderate, high or waived complexity tests i.e. in-patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.

The First Sign SARS-CoV-2 Antigen test does not differentiate between SARS-CoV  and SARS-CoV-2

Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen.  The antigen is generally detectable in direct nasal swab specimens during the acute phase of infection.  Positive results indicate the presence of viral antigens, but the 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 the disease.  Negative results should be treated as presumptive, and 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, and confirmed with a molecular assay, if necessary for patient management.

This test is intended for use by medical professionals or trained operators who are proficient in performing clinical laboratory personnel or individuals specifically trained in Point of Care settings.

A new coronavirus (201 -nCov) was identified in December 2019, which has since resulted in millions of confirmed human infections worldwide.  Cases of severe illness and hundreds of thousands of deaths worldwide have now been reported February 11, 2020 saw the International Committee of Taxonomy of Viruses (CTV) rename the virus SARS_CoV-2. 
  • The median incubation time is estimated to be approximately 5 days with symptoms to be present within 12 days of infection. 
  • The symptoms of COVID 19 are similar to other viral respiratory diseases and include fever, cough, shortness of breath. 
  • The First Sign  SARS-CoV-2 Antigen screen is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 directly from specimen swabs eluted in an extraction buffer solution. 
  • The First Sign  SARS-CoV-2 Antigen Test Kit contains all components required to conduct an assay for SARS-CoV-2.

To Read More    or    Datasheet 
Principles of test/ Precautions
Device Design / Test Materials
Storage & Stability
Specimen Collection & Handling
Pre-testing Procedure
Specimen Collection Procedure
Swab Extraction Procedure
Specimen Test Procedure
Result Interpretation
Quality Controls
Performance Characteristics
Device Limitation
Analytical Performance

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