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 detects proteins from SARS-CoV-2. Tests are only authorized for Point-of-Care use by qualified healthcare professionals.

The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

NOTE: For Serial Screening of asymptomatic individuals. The serial screening indication is only applied to products manufactured by Access Bio Inc. after April 12, 2021. The product batches listed in the Official Notification Letter (click to see) should not be marketed or used for POC serial screening purposes.

  • Lateral flow assay
  • Detect SARS-CoV-2 nucleocapsid protein antigen
  • Rapid results within 10-15 minutes
  • Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
  • For use under the Emergency Use Authorization (EUA) only
  • For in vitro diagnostic use only
  • For prescription use only
  • For use with direct anterior nasal and nasopharyngeal swab specimens

Clinical Performance

  • 93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab
  • 87.18% PPAa and 100% NPAb when used with anterior nasal swab

aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement.

RESULTS INTERPRETATION

Read the result at 10 minutes. The test result should not be read after 15 minutes.

Warning: The false positive, false negative, or invalid results may occur if the test is interpreted outside of the interpretation window.
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 positive.
Negative: Negative results are presumptive. 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, particularly in the presence of clinical signs and symptoms consistent with COVID-19, or in those who have been in contact with the virus. It is recommended that these results be confirmed by a molecular testing method, if necessary for patient management.
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.

ORDER INFORMATION
CAT. NO. RCHM-02071
PACKAGE UNIT 20 TESTS / KIT
KIT COMPONENT
20 TEST DEVICES
20 ASSAY BUFFER
20 EXTRACTION VIALS AND CAPS
20 SPECIMEN COLLECTION SWABS
1 POSITIVE AND 1 NEGATIVE CONTROL SWABS
1 INSTRUCTIONS FOR USE

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and The emergency use of this product 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is 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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