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Specialist/Clinicial Testing

Specialist/Clinicial Testing
First SignⓇSARS-C0V-2
Rapid Antigen Test
manufactured by W.H.P.M Inc USA
Immonoassay  nasal test for non-lab use  with SARS-CoV-2 Results in 15 Minutes
 
 
POINT OF CARE DESIGN
The First Sign® SARS-CoV-2 Antigen Test was designed with the Point-of-Care in mind. A simple to use, easy to understand testing process is key to the widespread adoption and correct application of SARS-CoV-2 rapid antigen tests. The First Sign® was developed with a high sensitivity bias, guaranteeing a reliable Limit of Detection (LoD), increasing total sensitivity, and guarding against false-negative results.
 
RELIABLE PERFORMANCE - 96.7% Clinical Sensitivity - 98.8% Clinical Specificity
The clinical performance characteristics of the FIRST SIGN® SARS-CoV-2 Antigen Test were evaluated in a multi-site prospective study in the United States of America in which patients were sequentially enrolled and tested. Testing was performed by operators with no laboratory experience and who are representative of the intended users at point of care (POC) testing sites. Patients who presented within five days of symptom onset and met study protocol criteria were enrolled in the study. At all sites, the standard of care swab eluted in VTM was tested with an EUA RT-PCR assay for the detection of SARS-CoV-2. The performance of the FIRST SIGN® SARS-CoV-2 Antigen Test was determined by testing 146 symptomatic patient samples and evaluating the level of agreement between operator reported antigen test results and results reported by an EUA RT-PCR comparator device.

SARS-CoV-2 Results in 15 Minutes

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RELIABLE PERFORMANCE - 96.7% Clinical Sensitivity - 98.8% Clinical Specificity

The clinical performance characteristics of the FIRST SIGN® SARS-CoV-2 Antigen Test were evaluated in a multi-site prospective study in the United States of America in which patients were sequentially enrolled and tested. Testing was performed by operators with no laboratory experience and who are representative of the intended users at point of care (POC) testing sites. Patients who presented within five days of symptom onset and met study protocol criteria were enrolled in the study. At all sites, the standard of care swab eluted in VTM was tested with an EUA RT-PCR assay for the detection of SARS-CoV-2. The performance of the FIRST SIGN® SARS-CoV-2 Antigen Test was determined by testing 146 symptomatic patient samples and evaluating the level of agreement between operator reported antigen test results and results reported by an EUA RT-PCR comparator device.

Patient Self-Sample Collection

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EASIER SAMPLING PROCESS

  • Nasal Swab (anterior nares) Specimen Self Collection

  • Recommended by the CDC as a Preferred Specimen

  • Fast, Non-invasive, Comfortable

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SMARTER SPECIMEN STORAGE

  • Patented Design Extraction Buffer Bottle for Safety

  • Minimize Exposure to Infectious Agents

  • Virus Neutralizing Buffer Solution

Simple Test Operation

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COMPLETE SARS-COV-2 Ag TEST KIT

  • No Special Equipment Needed

  • No Laboratory Training Required

  • Fast Results with Clear Lines in Minutes

 
 
For Use in non-lab environments  with results available in 15 minutes
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