KEY FEATURES OF OUR ANTIGEN TESTS

BENEFITS

*Minimum performance requirements for Antigen-detecting RDTs set by WHO is ≥80% for sensitivity and ≥97% for specificity (click here).

**AN=Anterior Nares; NP=Nasopharyngeal

SUPPORT DOCUMENTS

GENERAL COVID-19 DOCUMENTS

PRICING

FREQUENTLY ASKED QUESTIONS

Antigen tests detect proteins specific to a virus that appears in infected individuals, which indicates active infection.

• Urgency: Provide presumptive qualitative results onsite in a matter of minutes. Providing healthcare workers with more information at critical moments in the patients care.

• Volume: Fast turn-around testing of symptomatic patients can reduce the burden on hospitals and clinics. 

• Triage Efficiency: Presumptive antigen results for symptomatic patients allow hospitals to reduce doctor/patient interview time, further diminishing the chance of contagion in a hospital setting. 

• Cost: Effective low-cost alternative to RT-PCR testing

Our Antigen Tests detect the presence of viral proteins (antigens) expressed by the COVID-19 virus in a sample from a person’s respiratory tract (WHPM/First Sign®: nasal swab (anterior nares) - also CE marked for nasopharyngeal, oropharyngeal specimen collection; Access Bio/CareStart™: nasal swab (anterior nares) or nasopharyngeal swab). If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies fixed to the test strip enclosed in the cassette and generate a colored line within 10-20 minutes.

The antigen(s) detected are expressed only when the virus is actively replicating; therefore, such tests are best used to identify acute or early infection (within the first seven days of symptom onset).

The test line region of the COVID-19 Antigen Tests are coated with Anti-SARS-CoV-2 antibody. The strip has the follow detection lines:

• T - is fixed with the with the anti-SARS-CoV-2 antibody

• C - is fixed with the quality control antibody

During testing, the specimen reacts with anti-SARS-CoV-2 antibody-coated particles in the reaction pad. The mixture then migrates upward on the membrane by capillary action and reacts with the anti-SARS-CoV-2 antibody in the test line region (T).

If the specimen contains SARS-CoV-2 antigens, a colored line will appear in test line region (T) as a result of antigen capture. If the specimen does not contain antigens to SARS-CoV-2, no colored line will appear in the test line region (T), indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region (C), indicating that the proper volume of sample has been added and membrane wicking has occurred.

• Presumptive Positive (Line appears in T line area) = Patient has active SARS-CoV-2 infection. [1]

• Presumptive Negative (No line in T line area) = Patient does not have active SARS-CoV-2 infection. [2]

[1] Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

[2] Negative results from patients with symptom onset beyond seven days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.

WHPM/First Sign®: Results can be interpreted at 15-20 minutes after sample is added in the cassette sample well.

Access Bio/CareStart™: Results can be interpreted at 10-15 minutes after sample is added in the cassette sample well.

WHPM/First Sign®: The clinical sensitivity is 92.4% and clinical specificity is 98.8% when compared to RT-PCR. The relative accuracy rate is 96.0%.

Access Bio/CareStart™: For anterior nares specimen collection, the clinical sensitivity is 87.2% and clinical specificity is 100% when compared to RT-PCR. The relative accuracy rate is 94.6%.

For nasopharyngeal specimen collection, the clinical sensitivity is 93.8% and clinical specificity is 99.3% when compared to RT-PCR. The relative accuracy rate is 98.3%.

WHPM/First Sign®: The device should never be frozen. If refrigerated, ensure all test components to reach room temperature (15-30˚C / 59-86⁰F) before use. The advised storage for the First Sign® Antigen Test is 4-30°C / 40-86⁰F. The Antigen Test is stable until the expiration date marked on the outer packaging and containers.

Access Bio/CareStart™: The device should never be frozen. If refrigerated, ensure all test components to reach room temperature (15-30˚C / 59-86⁰F) before use. The advised storage for the CareStart™ Antigen Test is 1-30°C / 34-86⁰F. The Antigen Test is stable until the expiration date marked on the outer packaging and containers.

WHPM/First Sign®: The specimen should be tested immediately after collection. The specimen can be retained up to 1 hour following collection if immediate testing of specimens is not possible. Dispose of the specimen and recollect if retained for more than 1 hour.

Access Bio/CareStart™: Process the test sample immediately after collection. The specimens are stable for 4 hours in extraction buffer.

WHPM/First Sign®: The First Sign® Antigen Test is only available for purchase for highly complex labs in the US at the moment:

Due to the Coronavirus Public Health Emergency, the FDA updated its Policy for Diagnostic Tests for COVID-19 on March 16, 2020. Included in this update is guidance for commercial manufacturers, such as our test, for screening tests that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 from clinical specimens. On May 4, 2020 and May 11, 2020 it further refined its guidance to read as follows: “Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing. This policy does not apply to at-home testing, including at-home specimen collection, due to additional considerations that require FDA review.” While an application is under review, please note the following information:

• The test has not been reviewed by the FDA.

• 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.

• Negative results do not rule out SARS-CoV-2 infection, especially in those who have been exposed to the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in those individuals.

The results from rapid antibody testing should not be used as the sole basis to diagnose or exclude a COVID-19 infection or to determine an individual’s infection status.

Access Bio/CareStart™: The CareStart™ Antigen Test is available for purchase for highly/moderate complex labs in the US and CLIA waived Point of Care (POC) settings:

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

Professional Health Care institutions only. The First Sign® and CareStart™ Covid-19 Antigen Tests are NOT for home use.

Yes, COVID-19 Antigen Tests are reimbursable.

The American Medical Association (AMA) CPT Editorial Panel approved new and revised codes for COVID-19 testing in October 2020:

87636 - Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique.

87637 - Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique.

The panel also revised CPT codes ranging from 87301 to 87430 by removing the undefined term “multi step method” from the code descriptors. This revision clarifies how to properly report antigen tests that are read by a machine, as compared to those which can be visually interpreted without a machine. The change affects the newly developed descriptor for COVID-19 antigen tests described in CPT code 87426:

87426 - Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS-CoV-2 [COVID-19]).

In conjunction with that revision, the panel approved a new category I code, 87811, to report infectious agent antigen detection by immunoassay with direct visual observation:

87811 - Infectious agent antigen detection by immunoassay with direct optical (i.e., visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]).

For questions about CPT Codes refer to

In response to the COVID-19 pandemic, all providers, laboratories, and facilities performing testing for COVID-19 must report results to local public health authorities. This includes all types of tests, including those offered in point-of-care (POC) settings (e.g., traditional and rapid PCR, rapid antigen, serology).

Depending on one's local public health guidelines, healthcare providers offering POC serology tests should seek guidance locally for specific reporting guidelines and protocol/ instructions. 

Here are some resources available (applicable to USA):

CDC Reporting Guidelines: https://www.cdc.gov/coronavirus/2019-ncov/php/reporting-pui.html 

Local Health Department Directory: https://www.naccho.org/membership/lhd-directory 

Phone Numbers by state: https://www.cste.org/page/EpiOnCall  

WARNING

WHPM/First Sign®:

This test has not been reviewed by the FDA.

Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.

This test is limited to laboratories certified to perform high complexity testing, including testing at point-of-care when the site is covered by the laboratory's CLIA certificate of high-complexity testing.

This test is not for home-use or at-home specimen collection.

Access Bio/CareStart™:

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 i 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.

IMPORTANT NOTIFICATION

The FDA continues to update its guidance in its FAQ section. It is important to check their website daily for latest updates: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2.

Do you have any further questions?

Please contact us at sales@plymouthmedical.com or call our customer service hotline at 888-392-5076 Ext.1.