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CARESTART COVID-19 ANTIGEN TEST KIT
CORONAVIRUS IGG / IGM RAPID TEST

FDA EMERGENCY USE AUTHORIZATION (EUA) / CLIA WAIVED

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 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.

Due to the highly contagious nature and global spread, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical.

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 in symptomatic patients on a large scale.

CLIA WAIVED/FOR PROFESSIONAL USE ONLY: These tests are available for Medical Healthcare professionals only and are NOT intended for home use.
Please call for more information.

FEATURES:

CLINICAL FEATURES:

• Detects SARS-CoV-2 nucleocapsid protein antigen via a lateral flow assay
• Rapid results in 10 minutes – No lab equipment or additional instrument required
• Nasopharyngeal swab specimen collection
• Intended at POC setting (i.e., in patient 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

The CareStart™ 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 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.

FEATURES:

• Detects SARS-CoV-2 nucleocapsid protein antigen via a lateral flow assay
• Rapid results in 10 minutes – No lab equipment or additional instrument required
• Nasopharyngeal swab specimen collection
• Intended at POC setting (i.e., in patient care settings) by medical professionals with a CLIA waiver

CLINICAL FEATURES:

• Detect SARS-CoV-2 nucleocapsid protein antigen
• Identify acute infection with 88.4% sensitivity and
100% specificity
• Storage condition : 1-30 degrees celsius

The CareStart™ 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 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.

Related Documents

Instruction for Use
(IFU – US Only)
Emergency Use Authorization
(EUA – US Only)
Fact Sheet for Healthcare Providers
(US Only)
Fact Sheet for Patients
(US Only)

Test Principles

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.

PROCEDURE:

01

Peel off aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 5 times

02

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.

03

Close the vial by pushing the cap firmly onto the vial and mix thoroughly by flicking the bottom of the tube:

04

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.

Results Interpretation

Read the result at 10 minutes. The test result should not be read after15 minutes.

Positive

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

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 conrmed by a molecular
testing method, if necessary for patient management.

Invalid

Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.

Results Interpretation

Read the result at 10 minutes. The test result should not be read after15 minutes.

Positive

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

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 conrmed by a molecular
testing method, if necessary for patient management.

Invalid

Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.

The CareStart™ 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 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.