CARESTART™ COVID-19 Antigen Rapid Tests

EUA & POC Approved

Identify individual’s current infection status to COVID-19
Fast and easy to use in Point-of-Care setting
Qualitatively detect the SARS-CoV-2 nucleocapsid protein
Use nasopharyngeal (NP) swab specimens
Reliable results only in 10 minutes
No special equipment or training required
All-in-one package including collection swabs
93.75% PPA and 99.32% NPA when used with nasopharyngeal swab

The Ultimate POC Test With Reliable Results Within Minutes

Due to the highly contagious nature and global health crises, 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 theSARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomaticCOVID-19 cases is critical. Particularly, the identification of subclinical or asymptomatic cases is important to reduce or stop the infection because these individuals may transmit the virus.

As an intended point-of-care (POC) designated test with a 10 min processing time, CareStart™COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.

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 individuals who are suspected of COVID-19 by their healthcare providers.

Test Procedures

Direct Nasopharyngeal Swab Test Procedure

1

Peel off aluminum foil seal from the top of the extraction vial containing the extraction buffer

2

Place the swab into the extraction vial. Rotate the swab vigorously at least 5times.

3

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.

4

Close the vial with the provided cap and push firmly onto the vial.

5

Mix thoroughly by flicking the bottom of the tube.

6

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 in to the sample well. 2 drops of the sample are required minimum volume to initiate the test run and invalid results will be obtained if 1 drop of sample is added to the cassette. Leakage of the sample is possible when 6 drops or more of the sample are added.

7

Close the vial with the provided cap and push firmly onto the vial.

Results Interpretation

Positive

One red-colored line next to “C” and one blue-colored line next to “T” indicates COVID-19 positive result.

Negative

One red-colored line only next to “C” indicates a negative result.

Invalid

If the red-colored line in the control region “C” is not visible, the result is invalid. Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.

Tests Comparison

Test

Antibody lgM/lgG

RT-PCR

CareStart Antigen

Viral Detection

Rapid Screening

Sample

Blood

Swab

Swab

Patients with CPVOD-19 Symptoms

Patients with other symptoms

Patients without symptoms

Turn Around Time

Minutes

Hours to Days

Minutes

CARESTART™ COVID-19 Total Solution by Access Bio INC.

The Ultimate POC Test With Reliable Results Within Minutes

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