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


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


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


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 with the provided cap and push firmly onto the vial.


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 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.


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

Results Interpretation


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


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


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


Antibody lgM/lgG


CareStart Antigen

Viral Detection

Rapid Screening





Patients with CPVOD-19 Symptoms

Patients with other symptoms

Patients without symptoms

Turn Around Time


Hours to Days


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

The Ultimate POC Test With Reliable Results Within Minutes

download presentation