COVID-19 Testing Options

Antigen Testing

NEW! First-to-market rapid testing.

CareStart™ COVID-19 Antigen Test

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.

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.

Benefits
• Rapid results within 10 minutes
• No lab equipment or additional instrument required
• Nasopharyngeal swab specimen collection
• Detects SARS-CoV-2 nucleocapsid protein antigen via a lateral flow assay
• Designated as a CLIA waived tests

Features
• Lateral flow assay
• Rapid results in 10 minutes
• Nasopharyngeal 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

Kit Components
o 20 Test devices
o 20 Assay buffer
o 20 Extraction vials and caps
o 20 Specimen collection swabs
o 1 Positive and 1 negative control swabs
o 1 Instructions for Use

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 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.

Anti-Body Testing

Healgen COVID-19 IgG/IgM Test

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is authorized for the detection of IgG and IgM antibodies against SARS-CoV-2 in human serum, plasma (EDTA, lithium heparin, and sodium citrate), or venous whole blood.
  • This test has been authorized by FDA under an EUA for use by authorized laboratories.
  • This test has not been FDA cleared or approved.
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, 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.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • This product is intended for professional use and not for home use.
  • Not for the screening of donated blood.

RightSign™ COVID-19 IgG/IgM Rapid Test

RightSignTM COVID-19 IgG/IgM Rapid Test Cassette is authorized for the detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, or venous whole blood.
  • This test has been authorized by FDA under an EUA for use by authorized laboratories.
  • This test has not been FDA cleared or approved.
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, 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.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • This product is intended for professional use and not for home use.
  • Not for the screening of donated blood.

Assure COVID-19 IgG/IgM Test Cassette

This test has been authorized by FDA under an EUA for use by authorized laboratories. It is a point of care test for fingerstick whole blood specimens only. The user should be trained in the procedure. Wear appropriate protective attire for your safety when handling patient samples.
  • This test has been authorized by FDA under an EUA for use by authorized laboratories.
  • This test has not been FDA cleared or approved.
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, 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.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • This product is intended for professional use and not for home use.
  • Not for the screening of donated blood.
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