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 (Humasis Co/Celltrion DiaTrust™: nasal swab; Access Bio/CareStart™: nasal 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.

Humasis Co/Celltrion DiaTrust™: 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.

Humasis Co/Celltrion DiaTrust™: The clinical sensitivity is 93.3% and clinical specificity is 99.0% when compared to RT-PCR. The relative accuracy rate is 97.7%.

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%.

Humasis Co/Celltrion DiaTrust™: 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 2-30°C / 36-86⁰F. 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.

Humasis Co/Celltrion DiaTrust™: The specimen should be tested immediately after collection. If immediate testing is not possible, specimens should be stored immediately into extraction buffer and may be stored for up to 4 hours until testing. If testing cannot be performed within this time, a new specimen should be collected and tested.

Access Bio/CareStart™: Process the test sample immediately after collection. If immediate testing is not possible, specimens should be stored immediately into extraction buffer and may be stored for up to 4 hours until testing. If testing cannot be performed within this time, a new specimen should be collected and tested.

Humasis Co/Celltrion DiaTrust™: The Celltrion DiaTrust™ Antigen Test is available for non-prescription home use.

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.

Humasis Co/Celltrion DiaTrust™: Individuals for home use

Access Bio/CareStart™: Professional Health Care institutions only

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

Humasis Co/Celltrion DiaTrust™: The Celltrion DiaTrust™ COVID-19 Ag Test has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. 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. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.

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 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.

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.