COVID-19 Antigen Test Kit Swab (20 Test Box)
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 symptomatic individuals who are
suspected of COVID-19 by their healthcare providers.
It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. The Coronavirus Ag Antigen Test Kit (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.
As an intended Point-of-Care (POC) designated test with a 10 minute processing time, CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.
- Lateral flow assay
- Rapid results in 10 minutes
- Nasopharyngeal specimen collection
- Intended at POC setting (i.e., inpatient care settings) by medical professionals with a CLIA waiver
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Identify acute infection with 88.4% sensitivity and 100% specificity
- Storage condition: 1-30 degrees celsius
COVID-19 Antigen Test Components:
- 20 Test
- 20 Sterile Swabs
- 20 Vials and Caps
- 1 Positive and 1 Negative Control Swabs
- 2 Buffers
- 1 Package Insert
- 1 Instruction for Use
Procedure & Preparation
- Peel off the aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 5 times
- Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab.
- Close the vial by pushing the cap firmly onto the vial and mix thoroughly by flicking the bottom of the tube.
- Invert the extraction vial and hold the sample vertically above the sample well. Squeeze the vial gently. Allow three (3) drops of sample to fall into the sample well.
Covid-19 Antigen Rapid Test Kit Results Interpretation
Sample Results Interpretation
Read the result at 10 minutes. The test result should not be read after 15 minutes
SARS-CoV-2 antigen present does not rule out co-infection with other pathogens. The color intensity in the test region will vary depending on the amount of SARS-CoV-2 antigen present in the sample. Any faint colored line(s) in the test region(s) should be considered as positive.
Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions. It is recommended that these results be confirmed by a molecular testing method, if necessary for patient management.
Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.
The CareStartTM COVID-19 Antigen test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories and at the Point-of-Care by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been authorized only to detect the presence of the SARS CoV-2 nucleocapsid protein antigen, not for any other viruses or pathogens; this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.