P23 Labs TaqPath SARS-CoV-2 Assay Fact Sheet

: June 2, 2024
: FDA

Table of Contents

P23 Labs TaqPath SARS-CoV-2 Assay Fact Sheet

P23 Labs TaqPath SARS-CoV-2 Assay Fact Sheet

FACT SHEET FOR HEALTHCARE PROVIDERS

P23 LABS, LLC

P23 Labs TAQPATH SARS-COV-2 Assay

October 20, 2020
Coronavirus
Disease 2019
(COVID-19)

This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the P23 Labs TaqPath SARS-CoV-2 Assay .

The P23 Labs TaqPath SARS-CoV-2 Assay is authorized for use with respiratory and/or saliva specimens collected from individuals suspected of COVID-19 by their healthcare provider or self-collected using a home collection kit specified in the test’s instructions for use.

All patients whose specimens are tested with this assay will receive the Fact Sheet for Patients: P23 Labs TaqPath SARS-CoV-2 Assay.

What are the symptoms of COVID-19?

Many patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g.,
cough, dyspnea) although some individuals experience only mild symptoms or no symptoms at all. The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that, when present, symptoms include cough, shortness of breath or dyspnea, fever, chills, myalgias, headache, sore throat or new loss of taste or smell nausea or vomiting or diarrhea. Signs and symptoms may appear any time from 2 to 14 days after exposure to the virus
and the median time to symptom onset is approximately 5 days. For further information on the symptoms of COVID-19 please see the link provided in “Where can I go for updates and more information?” section.

Public health officials have identified cases of COVID-19 infection throughout the world, including the United States. Please check the CDC COVID-19 webpage (see link provided in “Where can I go for updates and more information?” section at the end of this document) or your local jurisdictions website for the most up to date
information.

What do I need to know about COVID-19 testing?

Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information?” section).

This test is to be performed only using respiratory and/or saliva specimens collected from individuals suspected of COVID 19 by their healthcare provider or self-collected using a home collection kit specified in the test’s instructions for use.

The P23 Labs TaqPath SARS-CoV-2 Assay can be used to test oropharyngeal (throat) swabs, nasopharyngeal swabs, anterior nasal and mid turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, bronchoalveolar lavage (BAL) specimens collected from individuals suspected of COVID-19 by their healthcare provider (HCP).
The P23 Labs TaqPath SARS-CoV-2 Assay can also be used to test saliva specimens that are self- collected at home or in a healthcare setting, with or without the supervision and/or assistance of a HCP, by individuals using the P23 At-Home COVID-19 Test Collection Kit when determined to be appropriate by a HCP based on the results of a COVID-19 medical questionnaire.
The P23 Labs TaqPath SARS-CoV-2 Assay can also be used to test nasal swab specimens that are self-collected at home or in a healthcare setting with or without the supervision and/or assistance of an HCP by individuals using the Everlywell COVID-19 Test Home Collection Kit or binx health At-home Nasal Swab COVID-19 Sample Collection Kit, when determined to be appropriate by an HCP based on the results of a COVID-19 medical questionnaire.
The P23 Labs TaqPath SARS-CoV-2 Assay is only authorized for use at P23 Labs, LLC, located at 500 S. University Ave., Suite 504, Little Rock, AZ 72205 or other laboratories designated by P23 Labs, LLC that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high complexity tests.

Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 infection control precautions are available at the CDC’s website (see links provided in “Where can I go for updates and more information” section). When collecting and handling specimens from individuals suspected of being infected with COVID-19, appropriate personal protective equipment should be used as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in “Where can I go for updates and more information” section).

What does it mean if the specimen tests positive for the virus that causes

COVID-19?

A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and therefore the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions. Patient management should be made by a healthcare provider
and follow current CDC guidelines.

The P23 Labs TaqPath SARS-CoV-2 Assay has been designed to minimize the likelihood of false positive test results. However, it is still possible that this test can give a false positive result, even when used in locations where the prevalence is below 5%. In the event of a false positive result, risks to patients could include the
following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.

All laboratories using this test must follow the standard testing and reporting guidelines according to their appropriate public health authorities.

What does it mean if the specimen tests negative for the virus that causes

COVID-19?

A negative test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. It is possible to test a person too early or too late during COVID-19 infection to make an accurate diagnosis via the P23 Labs TaqPath SARS-CoV-2 Assay.

When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID-
19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative.

If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing with an alternative method should be considered by healthcare providers in consultation with public health authorities. If a negative result is obtained with a saliva specimen and COVID-19 is still suspected based on exposure history together with other clinical findings, testing an alternative specimen type should be considered by healthcare providers in consultation with public health authorities.

Risks to a patient of a false negative include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.

What is an EUA?

The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.

An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19.

The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).

What are the approved available alternatives?

There are no approved available alternative tests. FDA has issued EUAs for other tests that can be found at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory- and-policy-framework/emergency-use-authorization.

Where can I go for updates and more information?

CDC webpages:

General : https://www.cdc.gov/COVID19
Healthcare Professionals : https://www.cdc.gov/coronavirus/2019-nCoV /guidance- hcp.html
Information for Laboratories : https://www.cdc.gov/coronavirus/2019-nCoV /guidance-laboratories.html
Laboratory Biosafety : https://www.cdc.gov/coronavirus/2019-nCoV/lab- biosafety-guidelines.html
Isolation Precautions in Healthcare Settings : https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control- recommendations.html
Specimen Collection : https://www.cdc.gov/coronavirus/2019-nCoV /guidelines-clinical-specimens.html
Infection Control : https://www.cdc.gov/coronavirus/2019-ncov/infection- control/index.html

FDA webpages:

General : www.fda.gov/novelcoronavirus
EUAs :(includes links to patient fact sheet and manufacturer’s instructions) https://www.fda.gov/medical-devices/coronavirus- disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro- diagnostics-euas

P23 Labs, LLC:

500 S. University Ave., Ste. 504
Little Rock, AR 72205

Customer Support :
+1 501-246-7311
accounts@p23labs.com

Technical Support :
+1 501-414-8859
QA@p23labs.com

Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088

P23 Labs TaqPath SARS-CoV-2 Assay Fact Sheet – Optimized PDF
P23 Labs TaqPath SARS-CoV-2 Assay Fact Sheet – Original PDF