Lateral flow Assay
No equipment required
Rapid results within 10 minutes
Minimally invasive specimen collection (nasopharyngeal swabs)
POC Setting (i.e., in patient care setting by medical professionals)
Detects Sars-CoV-2 nucleocapsid protein antigen with ultra high performance
Identify acute infection with 88.4% sensitivity and 100% specificity
20 Test Devices
20 Extraction vials and caps
20 NP swabs
1 positive and negative controls
Quick reference instructions (QRI)
1 Instructions for Use (IFU)
Video of Testing procedure
“This rapid test is easy to use and well tolerated by my patients. We get a highly accurate result within minutes. This is essential to our patients and our community.”
Cammy Benton MD
Benton Integrative Medicine
“Orders are processed and delivered promptly which is critical when demand is so high these days. ”
Dr. Robert Marus
The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from individuals who are suspected of Covid-19 by their healthcare providers.
1. Peel off aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 5 times.
2. Remove the swab, close the vial by pushing the cap onto the vial and squeeze the vial gently to release 3 drops of sample to the sample well.
3. Read the test results between 10 and 15 minutes
The color intensity in the test region will vary depending of the SARS-CoV-2 antigen present in the sample.
Any faint colored line in the test region should be considered as positive.
Rerun the test one time using the remaining specimen in the extraction vial.
Patient Fact Sheet
CPT Coding and Reimbursment
American Medical Association
Medicare and Medicaid Services
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