CareStart™ COVID-19 Antigen Test Kit, 20 tests per kit, by TENSnet
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 nasophylagial swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare providers.
Identify acute infection in symptomatic patients with 88.4% positive percent agreement and 100% negative percent agreement.
Lateral flow assay
Rapid results in 10 minutes
Nasopharyngeal swab specimen collection
Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
Detect SARS-CoV-2 nucleocapsid protein antigen
Designated as a CLIA waived tests
20 Test devices
20 Assay extraction buffer
20 Extraction vials and caps
20 Specimen collection swabs
1 Positive and 1 negative control swabs
1 Instruction for use
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