The RT-PCR technique targets a specific segment of the virus’ genetic material to detect the presence of COVID-19 in a person. RT-PCR works through nucleic acid-amplification technology by making thousands of copies of this genetic material to qualitatively assess if the virus is present. The tests only detect the virus while the person is currently infected.

A negative test result for this test means that SARS-CoV-2 RNA was not detected in the specimen. However, a negative result does not completely rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions.  When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of any recent exposure and clinical signs or symptoms that may suggest COVID-19.  The possibility of a false negative result should especially be considered if COVID-19 is clinically likely and diagnostic tests for other causes of illness (e.g., other respiratory illnesses) are negative.  If COVID-19 is still suspected, re-testing should be considered by healthcare providers in consultation with public health authorities.

A positive test result indicates that SARS-CoV-2 RNA was detected, and the patient is presumably infected with the virus and presumably contagious.  Laboratory test results should be considered in the clinical and community context to establish a final diagnosis and care plan.  Positive results do not rule out simultaneous bacterial infection or co-infection with other viruses.  Patient management decisions should be made by a healthcare provider and should follow the current CDC guidelines.  The COVID-19 test has been designed to minimize the likelihood of false-positive test results, but it may not be possible to completely exclude a false positive.

The Thermo Fisher TaqMan 2019-nCoV Assay Kit v1 and TaqMan 2019-nCoV Control Kit v1 Test and/or TaqPath COVID-19 Combo Kit – This assay is for in-vitro diagnostic use under FDA emergency use authorization (EUA). This test is only authorized for the duration of time the declaration should circumstances exist, justifying the EUA under the FDA emergency tests for detection of SARS-CoV-2 RNA virus and/ or diagnosis of COVID-19 infection under section 564(b)(1) of the act, 21U.S.C.360bbb-3(b)(1), unless the authorization is terminated or revoked. The genetic Sites being tested are OFR1, S Protein, and N Protein.

PLEASE NOTE: The Thermo Fisher TaqMan 2019-nCoV Assay Kit v1 and TaqMan 2019-nCoV Control Kit v1 Test and/or TaqPath COVID-19 Combo Kit is indicated as an aid in the diagnosis of specific agents of respiratory illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule out co-infection with organisms not included in the Thermo Fisher TaqMan 2019-nCoV Assay Kit v1 and TaqMan 2019-nCoV Control Kit v1 and/or TaqPath COVID-19 Combo Kit. The agent detected may not be the definite cause of this disease.

ThermoFisher Update

The Panther Fusion® SARS-CoV-2 Assay – This testing method is a real-time RT-PCR in vitro diagnostic test for the qualitative detection of RNA from SARS-CoV-2. SARS-CoV-2 Assay testing is intended for nasal and oropharyngeal (OP) swab specimens obtained for Individuals that meet the clinical and epidemiological criteria for COVID-19 testing. The Panther Fusion® SARS-CoV-2 Assay is for use only under the Emergency Use Authorization (EUA) in the US laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA, clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.

Hologic Update

PRICING OF DIAGNOSTIC TESTING.

In accordance with the Coronavirus Aid, Relief, and Economic Security Act “CARES Act” Section 3202 signed into law March 27, 2020; Integrity Laboratories is publishing a cash price of $150.00 for its high complexity molecular-based laboratory developed SARS-CoV-2 (COVID-19) test.

3202. R. 748—87 SEC. 3202.

(a) REIMBURSEMENT RATES –A group health plan or a health insurance issuer providing coverage of items and services described in section 6001(a) of division F of the Families First Coronavirus Response Act (Public Law 116–127) with respect to an enrollee shall reimburse the provider of the diagnostic testing as follows:

(1) If the health plan or issuer has a negotiated rate with such provider in effect before the public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d), such negotiated rate shall apply throughout the period of such declaration.

(2) If the health plan or issuer does not have a negotiated rate with such provider, such plan or issuer shall reimburse the provider in an amount that equals the cash price for such service as listed by the provider on a public internet website, or such plan or issuer may negotiate a rate with such provider for less than such cash price.

(b) REQUIREMENT TO PUBLICIZE CASH PRICE FOR DIAGNOSTIC TESTING FOR COVID–19.

(1) IN GENERAL — During the emergency period declared under section 319 of the Public Health Service Act (42 U.S.C. 247d), each provider of a diagnostic test for COVID–19 shall make public the cash price for such test on a public internet website of such provider.

(2) CIVIL MONETARY PENALTIES.—The Secretary of Health and Human Services may impose a civil monetary penalty on any provider of a diagnostic test for COVID–19 that is not in compliance with paragraph (1) and has not completed a corrective action plan to comply with the requirements of such paragraph, in an amount not to exceed $300 per day that the violation is ongoing.

https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf