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Data for Laboratories about Coronavirus (COVID-19)


Abstract of Latest Adjustments

Revisions had been made on December 5, 2020 together with:

  • The phrase “speedy” has been deleted as a result of FDA has approved laboratory-based antigen exams.
  • New part on processing of antigen exams, reflecting what has been realized on how you can decrease the chance of false outcomes.
  • Revised part on evaluating the outcomes of antigen exams, introducing a brand new testing algorithm, and reflecting what has been realized concerning the efficiency of antigen exams and the necessity to implement confirmatory testing.

Word: Antigen exams can be utilized in a wide range of testing methods to reply to the coronavirus illness 2019 (COVID-19) pandemic. This interim steering is meant for clinicians who order antigen exams, obtain antigen take a look at outcomes, and carry out point-of-care testing, in addition to for laboratory professionals who carry out antigen testing in a laboratory setting or on the level of care and report these outcomes. The aim of this interim technical steering is to help efficient scientific use of antigen exams for various testing conditions. This steering applies to all scientific makes use of of antigen exams and isn’t particular to any explicit age group or setting. This steering dietary supplements and is in step with CDC’s Overview of Testing for SARS-CoV-2 steering. CDC has additionally offered a Abstract of concerns for utilizing antigen exams in nursing properties.

Antigen Testing for SARS-CoV-2

Normal Steering
Antigen exams are generally used within the analysis of respiratory pathogens, together with influenza viruses and respiratory syncytial virus. The U.S. Meals and Drug Administration (FDA) has granted emergency use authorization (EUA) for antigen exams that may determine SARS-CoV-2. See FDA’s checklist of
In Vitro Diagnostics EUAsexterior icon.

Antigen exams are immunoassays that detect the presence of a selected viral antigen, which suggests present viral an infection. Antigen exams are at present approved to be carried out on nasopharyngeal or nasal swab specimens positioned instantly into the assay’s extraction buffer or reagent. The at present approved antigen exams aren’t restricted to make use of on individuals of a sure age. See Desk 1 for added details about antigen exams.

Antigen exams are comparatively cheap, and most can be utilized on the level of care. A lot of the at present approved exams return ends in roughly quarter-hour. Antigen exams for SARS-CoV-2 are usually much less delicate than real-time reverse transcription polymerase chain response (RT-PCR) and different nucleic acid amplification exams (NAATs) for detecting the presence of viral nucleic acid. Nonetheless, RT-PCR can detect ranges of viral nucleic acid that can’t be cultured, suggesting that the presence of viral nucleic acid doesn’t at all times point out contagiousness.

Correct interpretation of each antigen take a look at outcomes and confirmatory testing when indicated is vital for correct scientific administration of sufferers with suspected COVID-19, or for identification of contaminated individuals when used for screening.

The scientific efficiency of antigen diagnostic exams largely depends upon the circumstances during which they’re used. Each antigen exams and NAATs carry out greatest when the particular person is examined when viral load is mostly highest. Additionally they could also be informative in diagnostic testing conditions during which the particular person has a recognized publicity to an individual with COVID-19.

There are growing quantities of knowledgeexterior icon to assist information the usage of antigen exams as screening exams on asymptomatic individuals to detect or exclude COVID-19, or to find out whether or not an individual who beforehand was identified with COVID-19 stays infectious. See FDA’s Suggestions for healthcare suppliers utilizing SARS-CoV-2 diagnostic exams for screening asymptomatic people for COVID-19exterior icon. Additionally see info from the Facilities for Medicare & Medicaid Companies (CMS) on Enforcement discretion for the usage of SARS-CoV-2 point-of-care testing on asymptomatic people.pdf icon.

Antigen exams can be utilized for screening testing in high-risk congregate settings during which repeat testing might rapidly determine individuals with a SARS-CoV-2 an infection to tell an infection prevention and management measures, thus stopping transmission. On this case, and particularly in settings the place a speedy take a look at turnaround time is required, there may be worth in offering rapid outcomes with antigen exams, despite the fact that they could have decrease sensitivity than NAATs.

Clinicians and public well being practitioners ought to perceive take a look at efficiency traits to acknowledge probably false destructive or false constructive take a look at outcomes and to information extra confirmatory testing and affected person administration. Laboratory and testing professionals who carry out antigen exams ought to perceive the elements that have an effect on the accuracy of antigen testing, as described on this steering. Clinicians, laboratory and testing professionals, and public well being practitioners also needs to perceive the variations amongst diagnostic, screening, and surveillance testing. See CDC’s Overview of Testing for SARS-CoV-2, and Testing Methods for SARS-CoV-2. Additionally see FDA’s FAQs on Testing for SARS-CoV-2exterior icon.

Regulatory Necessities for Utilizing Antigen Exams for SARS-CoV-2

FDA regulates in vitro diagnostic gadgets and has offered suggestions and knowledge relating to EUA requests for COVID-19 diagnostic exams within the Coverage for Coronavirus Illness-2019 Exams Through the Public Well being Emergency (Revised) (“Coverage for COVID-19 Exams”)exterior icon and the EUA templates referenced in that coverage. COVID-19 assays and take a look at techniques used for diagnostic or screening testing, together with these for antigen testing, should have acquired an EUA from FDA or be supplied underneath the insurance policies in FDA’s Coverage for COVID-19 Examsexterior icon. Any antigen take a look at for SARS-CoV-2 approved to be used by FDA is included on FDA’s checklist of In Vitro Diagnostics EUAsexterior icon.

Laboratory and testing professionals who conduct diagnostic or screening testing for SARS-CoV-2 with antigen exams should additionally adjust to Medical Laboratory Enchancment Amendments (CLIA) laws. Any laboratory or testing website that intends to report patient-specific take a look at outcomes should first receive a CLIA certificates and meet all necessities to carry out that testing. For extra info, see CMS’ The way to Receive a CLIA Certificatespdf icon. CMS has offered extra info on Enforcement discretion for the usage of SARS-CoV-2 point-of-care testing on asymptomatic people.pdf icon.

Analytical Efficiency of Antigen Exams for SARS-CoV-2

It is vital for clinicians and testing personnel to grasp the analytic efficiency traits, together with sensitivity, specificity, and constructive and destructive predictive values, of the actual antigen take a look at getting used, and to comply with the producer’s directions and package deal insert. See FDA’s In Vitro Diagnostics EUAsexterior icon for detailed details about the efficiency of particular approved exams.

The “gold normal” for scientific diagnostic detection of SARS-CoV-2 stays NAATs, similar to RT-PCR. Thus, it could be vital to substantiate an antigen take a look at consequence with a nucleic acid amplification take a look at, particularly if the results of the antigen take a look at is inconsistent with the scientific context. Desk 1 summarizes the variations between NAATs and antigen exams. Analytic efficiency could differ from general efficiency when contemplating problems with take a look at availability, high quality of specimen assortment and transport, and turnaround instances of outcomes.

The sensitivity of antigen exams varies however is mostly decrease than most NAATs. The antigen degree in specimens collected both earlier than symptom onset, or late in the midst of an infection, could also be under the restrict of detection of virus of the take a look at. This will lead to a destructive antigen take a look at consequence, whereas a extra delicate take a look at, similar to most NAATs, could return a constructive consequence.

The specificity of antigen exams is mostly as excessive as most NAATs, which signifies that false constructive take a look at outcomes are unlikely when an antigen take a look at is used based on the producer’s directions. Regardless of the excessive specificity of antigen exams, false constructive outcomes will happen, particularly when utilized in communities the place the prevalence of an infection is low – a circumstance that’s true for all in vitro diagnostic exams. CDC considers low prevalence to be when NAAT positivity during the last 14 days is lower than 5% or when there are fewer than 20 new circumstances of COVID-19 per 100,000 individuals throughout the final 14 days. See CDC’s Indicators and thresholds for danger of introduction and transmission of COVID-19 in faculties. Normally, the decrease the prevalence of an infection in the neighborhood, the upper the speed of false constructive take a look at outcomes.

Optimistic and destructive predictive values of all in vitro diagnostic exams (e.g., NAAT and antigen assays) differ relying upon the pretest likelihood. Pretest likelihood considers each the prevalence of the goal an infection in the neighborhood in addition to the scientific context of the person being examined. If the prevalence of an infection in the neighborhood is excessive, and the particular person being examined is symptomatic, then the pretest likelihood is mostly thought-about excessive. If the prevalence of an infection in the neighborhood is low, and the particular person being examined is asymptomatic and has not had any recognized contact to an individual with COVID-19, then the pretest likelihood is mostly thought-about low. See CDC’s Deciphering Outcomes of Diagnostic Exams for added info on the connection between pretest likelihood and the chance of constructive and destructive predictive values.

To assist estimate pretest likelihood, CDC recommends that laboratory and testing professionals who carry out antigen testing decide an infection prevalence primarily based on a rolling common of the positivity price of their very own SARS-CoV-2 testing over the earlier 7–10 days. If a selected testing website, similar to a nursing house, has a take a look at positivity price close to zero, the prevalence of illness in the neighborhood (e.g., circumstances among the many inhabitants) ought to as a substitute be used to assist decide pretest likelihood. State well being departments usually publish COVID-19 knowledge on testing positivity charges and case charges for his or her communities.

Processing of Antigen Exams for SARS-CoV-2

The Circumstances of Authorization within the antigen EUAs specify that CLIA-certified laboratories and testing websites are to comply with the producer’s directions to be used, usually discovered within the package deal insert, when performing the take a look at and studying take a look at outcomes. The approved directions to be used for every take a look at will also be discovered at FDA’s In Vitro Diagnostics EUAsexterior icon.

For instance, the efficiency of antigen exams might be affected if the take a look at elements aren’t saved and dealt with correctly. They need to by no means be frozen and will at all times be dropped at room temperature (15-30°C) earlier than use. The package deal insert for these exams consists of directions for dealing with of the take a look at cartridge/card, similar to guaranteeing it stays in its sealed pouch till instantly earlier than use.

The package deal insert for antigen exams additionally consists of directions about how you can learn the take a look at outcomes, together with the suitable time to learn the outcomes and whether or not the outcomes needs to be interpreted visually or with an instrument analyzer. Studying the take a look at earlier than or after the desired time might lead to false constructive or false destructive take a look at outcomes.

Processing a number of specimens successively or in batch mode could make it more difficult to make sure that every specimen is incubated for the correct quantity of time earlier than the result’s learn. Consult with the package deal insert for the proper incubation time for that take a look at, after which monitor and guarantee correct timing for every specimen throughout testing and when studying outcomes.

All testing for SARS-CoV-2, together with antigen testing, depends upon the integrity of the specimen, which is affected by procedures for each specimen assortment and dealing with. Improper specimen assortment, similar to swabbing the nostril too rapidly, could trigger inadequate specimen assortment, leading to restricted quantities of viral genetic or antigenic materials for detection. Time from pattern assortment to testing needs to be minimized, and the temperature of the specimen throughout this time should be managed. See CDC’s Interim Tips for Gathering, Dealing with, and Testing Medical Specimens for COVID-19.

High quality assurance procedures needs to be adopted to stop cross-contamination and inaccurate take a look at outcomes. For instance, customers ought to comply with the producer’s directions, in addition to state and native steering, for when and the way usually to carry out testing on management specimens. If antigen testing returns a number of surprising constructive outcomes, it could be applicable to cease testing affected person specimens, assessment all procedures, disinfect all surfaces, change gloves, and run management specimens earlier than restarting the testing of affected person specimens.

Decontaminate work surfaces and tools with applicable disinfectants through the use of an EPA-approved disinfectant for SARS-CoV-2, following the producer’s suggestions to be used, similar to dilution, contact time, and protected dealing with. See EPA’s Listing of Disinfectants for COVID-19exterior icon. Gloves needs to be modified earlier than gathering, dealing with, and processing a brand new specimen within the antigen take a look at system. Failing to vary gloves can enhance the chance of cross-contamination and false antigen take a look at outcomes. See CDC’s steering on Level-of-Care Testing, and Interim Laboratory Biosafety Tips for Dealing with and Processing Specimens Related to Coronavirus Illness 2019 (COVID-19).

Some antigen assays have explored the usage of viral transport medium (VTM) throughout pattern assortment, however the usage of VTM could dilute the specimen and should lower the sensitivity of the assay (presumably inflicting false take a look at outcomes). Laboratories and testing websites ought to discuss with the directions to be used and the package deal insert which can be particular for the take a look at that they’re utilizing relating to the usage of VTM.

Additionally see FDA’s Letter to Medical Laboratory Employees and Well being Care Suppliersexterior icon on the potential for false constructive outcomes with antigen exams, and CDC’s steering on Level-of-Care Testing.

Evaluating the Outcomes of Antigen Testing for SARS-CoV-2

Evaluating the outcomes of an antigen take a look at for SARS-CoV-2 ought to bear in mind the efficiency traits (e.g., sensitivity, specificity) and the directions to be used of the FDA-authorized assay, the prevalence of SARS-CoV-2 an infection in that exact group (positivity price over the earlier 7–10 days or the speed of circumstances in the neighborhood), and the scientific and epidemiological context of the one that has been examined.

The analysis of an antigen take a look at consequence ought to take into account whether or not, and if that’s the case the size of time, the affected person has skilled signs. Usually, clinicians can depend on a constructive antigen take a look at consequence for a symptomatic affected person as a result of the specificity of present FDA-authorized antigen exams is excessive.

The sensitivity of present FDA-authorized antigen exams varies, and thus destructive diagnostic testing outcomes needs to be dealt with in a different way relying on the take a look at, its said efficiency traits, and meant software (e.g., scientific analysis, screening). Usually, the producers’ directions to be used of antigen exams point out that destructive take a look at outcomes needs to be thought-about “presumptive,” that means that they’re preliminary outcomes. See FDA’s In Vitro Diagnostics EUAsexterior icon.

It could be applicable to substantiate antigen take a look at outcomes with one other take a look at. CDC recommends following its antigen testing algorithm (Determine 1) to find out when confirmatory testing is advisable.

Determine 1. Antigen Check Algorithm

1Single, a number of, or steady recognized publicity to an individual with COVID-19 throughout the final 14 days; carry out NAAT first if quick turnaround time is out there, if particular person can’t be successfully and safely quarantined, or if there are boundaries to potential confirmatory testing
2No recognized publicity to an individual with COVID-19 throughout the final 14 days
3If a symptomatic particular person has a low chance of SARS-CoV-2 an infection, scientific discretion ought to decide if this destructive antigen take a look at consequence requires confirmatory testing
4In cases of upper pretest likelihood, similar to excessive incidence of incidence of an infection in the neighborhood, scientific discretion ought to decide if this constructive antigen consequence requires affirmation
5In sure settings, serial antigen testing may very well be thought-about for these with a destructive antigen take a look at consequence; serial testing could not require affirmation of destructive outcomes
6If prevalence of an infection will not be low in the neighborhood, scientific discretion ought to take into account whether or not this destructive antigen consequence requires affirmation
7Nucleic acid amplification take a look at; affirm inside 48 hours utilizing a NAAT, similar to RT-PCR, that has been evaluated in opposition to FDA’s reference panel for analytical sensitivity
8Identified publicity to an individual with COVID-19 throughout the final 14 days; if not sure, scientific discretion ought to decide whether or not isolation is important
9Isolation is important for at the very least 10 days since symptom onset or constructive take a look at consequence, and at the very least 24 hours with no fever with out fever-reducing treatment
10An infection management measures are vital for 14 days after final recognized publicity to an individual with COVID-19; scientific discretion ought to decide if and when extra testing is important

Testing a symptomatic particular person – excessive pretest likelihood

Presently, the antigen exams which have acquired EUAs from FDA are approved for diagnostic testing in symptomatic individuals. The particular authorizations differ from take a look at to check. See FDA’s In Vitro Diagnostics EUAsexterior icon.

When testing an individual who has signs related to COVID-19, indicating that pretest likelihood is excessive, the healthcare supplier usually can interpret a constructive antigen take a look at to point that the particular person is contaminated with SARS-CoV-2. A destructive antigen take a look at consequence for a symptomatic particular person needs to be confirmed with an FDA-authorized NAAT. CDC recommends utilizing a NAAT that has been evaluated in opposition to the FDA reference panel for analytical sensitivity. See FDA’s SARS-CoV-2 Reference Panel Comparative Informationexterior icon. See the antigen testing algorithm when pretest likelihood is excessive, Determine 2, which is excerpted instantly from the complete antigen testing algorithm in Determine 1. If the particular person has a low chance of SARS-CoV-2 an infection (e.g., no recognized publicity), scientific judgement needs to be used to find out whether or not a confirmatory NAAT needs to be carried out.

Determine 2. Antigen Testing Algorithm – Excessive Pretest Chance

Figure 2 Antigen Test Algorithm

3If a symptomatic particular person has a low chance of SARS-CoV-2 an infection, scientific discretion ought to decide if this destructive antigen take a look at consequence requires confirmatory testing
7Nucleic acid amplification take a look at; affirm inside 48 hours utilizing a NAAT, similar to RT-PCR, that has been evaluated in opposition to FDA’s reference panel for analytical sensitivity
8Identified publicity to an individual with COVID-19 throughout the final 14 days; if not sure, scientific discretion ought to decide whether or not isolation is important
9Isolation is important for at the very least 10 days since symptom onset and at the very least 24 hours with no fever with out fever-reducing treatment
10An infection management measures are vital for 14 days after final recognized publicity to an individual with COVID-19; scientific discretion ought to decide if and when extra testing is important

When a symptomatic particular person receives a destructive antigen take a look at consequence adopted by a destructive confirmatory NAAT, the healthcare supplier ought to think about whether or not the particular person has had publicity to an individual with COVID-19 throughout the previous 14 days. If the particular person has had publicity, that particular person ought to comply with an infection management measures for 14 days after their most up-to-date publicity to an individual with COVID-19.

Testing an asymptomatic one who has had shut contact with an individual with COVID-19 – reasonable pretest likelihood

When testing an individual who’s asymptomatic and has had publicity to an individual with COVID-19 throughout the final 14 days, indicating that the pretest likelihood is reasonable, the healthcare supplier ought to affirm a constructive antigen take a look at consequence with an FDA-authorized NAAT. See the antigen testing algorithm when pretest likelihood is reasonable, Determine 3, which is excerpted instantly from the complete antigen testing algorithm in Determine 1. Individuals who obtain a constructive antigen take a look at consequence that ought to endure confirmatory testing ought to isolate whereas awaiting outcomes of the confirmatory testing.

Determine 3. Antigen Testing Algorithm – Reasonable Pretest Chance

Figure 3 Antigen Test Algorithm

1Single, a number of, or steady recognized publicity to an individual with COVID-19 throughout the final 14 days; carry out NAAT first if quick turnaround time is out there, if particular person can’t be successfully and safely quarantined, or if there are boundaries to potential confirmatory testing
4In cases of upper pretest likelihood, similar to excessive incidence of incidence of an infection in the neighborhood, scientific discretion ought to decide if this constructive antigen consequence requires affirmation
5In sure settings, serial antigen testing may very well be thought-about for these with a destructive antigen take a look at consequence; serial testing could not require affirmation of destructive outcomes
7Nucleic acid amplification take a look at; affirm inside 48 hours utilizing a NAAT, similar to RT-PCR, that has been evaluated in opposition to FDA’s reference panel for analytical sensitivity
9Isolation is important for at the very least 10 days since symptom onset or constructive take a look at consequence, and at the very least 24 hours with no fever with out fever-reducing treatment
10An infection management measures are vital for 14 days after final recognized publicity to an individual with COVID-19; scientific discretion ought to decide if and when extra testing is important

In cases of upper pretest likelihood, similar to excessive incidence of an infection in the neighborhood, or an individual with family or steady contact to an individual with COVID-19, scientific judgement ought to decide if a constructive antigen consequence for an asymptomatic particular person needs to be adopted by a confirmatory NAAT.

The healthcare supplier ought to direct the one that acquired a destructive antigen take a look at consequence, or a destructive confirmatory NAAT consequence, to quarantine for 14 days after the final recognized publicity to an individual with COVID-19. Medical judgement ought to decide if and when extra testing is important.

On this reasonable pretest likelihood state of affairs, the healthcare supplier ought to take into account performing a NAAT first if quick take a look at turnaround time is out there, if the particular person can’t be successfully and safely quarantined, or if there are boundaries to potential confirmatory testing (e.g., journey boundaries for follow-up testing, tolerance of a number of specimen collections).

Testing an asymptomatic particular person with no recognized publicity to an individual with COVID-19 – low pretest likelihood

Healthcare suppliers ought to take into account pretest likelihood when utilizing antigen exams as screening exams, and confirmatory testing could also be required for scientific administration and public well being decision-making. See every take a look at’s directions to be used at FDA’s In Vitro Diagnostics EUAsexterior icon, and see FDA’s Suggestions for healthcare suppliers utilizing SARS-CoV-2 diagnostic exams for screening asymptomatic people for COVID-19exterior icon. Additionally see CMS’ Enforcement discretion for the usage of SARS-CoV-2 point-of-care testing on asymptomatic peoplepdf icon.

When testing an individual who’s asymptomatic and has not had recognized publicity to an individual with COVID-19 throughout the final 14 days, indicating that the pretest likelihood is low, the healthcare supplier usually can interpret a destructive antigen take a look at to point that the particular person will not be contaminated with SARS-CoV-2. If the prevalence of SARS-CoV-2 an infection will not be low in the neighborhood, scientific judgement ought to take into account whether or not this destructive antigen take a look at consequence needs to be adopted by a confirmatory NAAT. See the antigen testing algorithm when pretest likelihood is low, Determine 4, which is excerpted instantly from the complete antigen testing algorithm in Determine 1.

Determine 4. Antigen Testing Algorithm – Low Pretest Chance

Figure 4 Antigen Test Algorithm

2No recognized publicity to an individual with COVID-19 throughout the final 14 days
6If prevalence of an infection will not be low in the neighborhood, scientific discretion ought to take into account whether or not this destructive antigen consequence requires affirmation
7Nucleic acid amplification take a look at; affirm inside 48 hours utilizing a NAAT, similar to RT-PCR, that has been evaluated in opposition to FDA’s reference panel for analytical sensitivity
9Isolation is important for at the very least 10 days since symptom onset or constructive take a look at consequence, and at the very least 24 hours with no fever with out fever-reducing treatment
10An infection management measures are vital for 14 days after final recognized publicity to an individual with COVID-19; scientific discretion ought to decide if and when extra testing is important

Due to issues about false constructive outcomes when pretest likelihood is low, a constructive antigen take a look at consequence on this circumstance needs to be adopted by a confirmatory NAAT, recognizing that the particular person shall be examined at a later timepoint of their sickness if actually contaminated. Individuals who obtain a constructive antigen take a look at consequence that ought to endure confirmatory testing ought to quarantine whereas awaiting outcomes of the confirmatory testing.

Confirmatory testing when utilizing antigen exams

Because the antigen testing algorithm signifies, confirmatory testing could also be wanted whatever the symptom or publicity standing of the particular person being examined, or the pretest likelihood. Confirmatory testing ought to happen as quickly as potential after the antigen take a look at, and never longer than 48 hours after the preliminary antigen testing. If greater than 48 hours separate the 2 specimen collections, or if there have been alternatives for brand new exposures, a NAAT needs to be thought-about a separate take a look at – not a affirmation of the sooner take a look at. If the outcomes are discordant between the antigen take a look at and the confirmatory NAAT, generally the confirmatory take a look at consequence needs to be interpreted as definitive for the aim of scientific analysis.

Nonetheless, a number of research have documented persistent detection of virus utilizing RT-PCR after restoration; in these circumstances, the individuals didn’t appear to be infectious to others. Thus, if the particular person being examined has lately had COVID-19, it’s potential for that particular person to obtain a destructive antigen take a look at consequence and a constructive confirmatory NAAT, probably indicating a persistent detection of SARS-CoV-2 after restoration from COVID-19. See CDC’s Medical Questions on COVID-19: Questions and Solutions.

If confirmatory testing will not be out there, scientific discretion can decide whether or not to advocate that the affected person isolate or quarantine. See CDC’s steering on Testing in Nursing Properties, Quarantine and IsolationDiscontinuation of Isolation for Individuals with COVID-19 Not in Healthcare SettingsDiscontinuation of Transmission-Based mostly Precautions of Sufferers in Healthcare Settings, and Return to Work for Healthcare Personnel.

Serial testing when utilizing antigen exams

Relying on the circumstances and setting, it could be helpful to implement serial antigen testing for individuals who obtain a destructive antigen take a look at consequence. Serial antigen testing inside a closed congregate setting, similar to a long-term care facility or a correctional or detention facility, might rapidly determine somebody with a SARS-CoV-2 an infection and stop additional transmission. It is probably not essential to carry out confirmatory testing with a NAAT when conducting serial antigen testing on those that have acquired a destructive antigen take a look at consequence. Serial testing, notably in congregate settings when it has been potential to quarantine individuals for 14 days, shouldn’t proceed indefinitely.

Modeling proofexterior icon exhibits that outbreak management relies upon largely on the frequency of testing, the velocity of reporting, and the appliance of interventions, and is barely marginally improved by the sensitivity of the take a look at. Further proofpdf icon exhibits the worth of repeat testing, utilizing NAATs with quick turnaround instances, for informing scientific and public well being decision-making. For that reason, serial antigen testing could have advantages for early identification and controlling outbreaks in some conditions, similar to congregate residing, in comparison with laboratory-based NAATs with extended turnaround instances. See CDC’s steering on Testing in Nursing Properties and FDA’s Suggestions for healthcare suppliers utilizing SARS-CoV-2 diagnostic exams for screening asymptomatic people for COVID-19exterior icon.

CDC will replace this steering as extra knowledge turn into out there.

Reporting Antigen Check Outcomes for SARS-CoV-2 to Well being Departments and Sufferers

A CLIA-certified laboratory or testing website should report antigen diagnostic take a look at outcomes to the native, state, tribal, or territory well being division in accordance with Public Legislation 116-136, § 18115(a), the Coronavirus Support, Aid, and Financial Safety (CARES) Act. The CARES Act requires “each laboratory that performs or analyzes a take a look at that’s meant to detect SARS-CoV-2 or to diagnose a potential case of COVID-19” to report the outcomes of every such take a look at. Antigen take a look at outcomes which can be reported to public well being departments should be clearly distinguished from different COVID-19 exams, similar to NAATs and antibody exams.

On June 4, 2020, the U.S. Division of Well being and Human Companies revealed steering on COVID-19 Pandemic Response, Laboratory Information Reporting: CARES Act Part 18115pdf icon that specifies what extra knowledge needs to be collected and electronically reported to well being departments together with COVID-19 diagnostic or screening take a look at outcomes. Laboratory and testing professionals ought to gather and report full affected person demographic info and be certain that they report antigen take a look at outcomes utilizing the right LOINC code for his or her explicit FDA-authorized assays. Services ought to discuss with CDC’s LOINC In Vitro Diagnostic (LIVD) Check Code Mapping for SARS-CoV-2 Exams.

A CLIA-certified laboratory or testing website should report antigen take a look at outcomes to the person or the person’s healthcare supplier based on the directions to be used of the FDA-authorized SARS-CoV-2 in vitro diagnostic gadget that was used. Relying on the stipulations of the FDA authorization, the laboratory or testing website could also be required to report destructive take a look at outcomes to sufferers as “presumptive destructive.”

For long-term care amenities which can be enrolled in CDC’s Nationwide Healthcare Security Community (NHSN), the popular technique for reporting point-of-care SARS-CoV-2 testing knowledge, together with antigen take a look at outcomes, is thru the NHSN.



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