Regular price
$395.00
Sale price
$395.00
Regular price
$500.00
Unit price
21% OFF
CareStart™ Rapid Antigen Test Kit (FDA/EUA)
- Lateral flow assay
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Rapid results within 10-15 minutes
- For use under the Emergency Use Authorization (EUA)
The Access Bio, Inc. 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 nasopharyngeal swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare provider. As an intended point-of-care (POC) designated test performed by medical professionals with a 10 minutes processing time, CareStart™ COVID-19 Antigen Test helps provide critical answers about active infections to patients and healthcare workers alike.
- For in vitro diagnostic use only
- For use with direct anterior nasal or nasopharyngeal swab specimens
- 93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab
- 87.18% PPAa and 100% NPAb when used with anterior nasal swab
- (20) Test devices
- (20) Assay buffers
- (20) Extraction vials and caps
- (20) Specimen collection swabs
- Positive and negative control swabs
- Instruction for Use
The CareStart™ COVID-19 Antigen is a type of test called an antigen test. Antigen tests are designed to detect proteins from the virus that causes COVID-19 in nasopharyngeal or anterior nasal swab samples collected by a healthcare provider.
Testing of your specimen(s) will help find out if you may have COVID-19.
If you have a positive test result with the CareStart™ COVID-19 Antigen test, it is very likely that you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. You should follow CDC guidance to reduce the potential transmission of disease.
Eighty-three percent of adults and 87% of children were asymptomatic. CareStart sensitivity/specificity were 84.8% (95% confidence interval [CI], 71.1–93.7)/97.2% (95% CI, 92.0–99.4) and 85.7% (95% CI, 42.1–99.6)/89.5% (95% CI, 66.9–98.7) in adults and children, respectively, within 5 days of symptoms.
Because access is everything.
Access Bio is dedicated to the prevention and early diagnosis of infectious diseases through research, development, and manufacturing of in vitro rapid diagnostic tests, biosensor, and molecular diagnostic products. Based on the greatest needs and the potential to do the most good, we work with partners across the world.
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About Access Bio
Because access is everything.
Access Bio is dedicated to the prevention and early diagnosis of infectious diseases through research, development, and manufacturing of in vitro rapid diagnostic tests, biosensor, and molecular diagnostic products. Based on the greatest needs and the potential to do the most good, we work with partners across the world.
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