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Info for Laboratories about Coronavirus (COVID-19)

Revisions had been made on December 2, 2020 to replicate the next:

  • Modified web page to incorporate Steadily Requested Questions on Level-of-Care Testing

Level-of-care (POC) checks, equivalent to some fast checks for diagnosing an infectious illness, present outcomes inside minutes of the check being administered, permitting for fast selections about affected person care. POC checks may lengthen testing to communities and populations that can’t readily entry care. POC checks are used to diagnose COVID-19 in varied settings, equivalent to:

  • Doctor places of work
  • Pressing care amenities
  • Pharmacies
  • College well being clinics
  • Lengthy-term care amenities and nursing properties
  • Non permanent places, equivalent to drive-through websites managed by native organizations

Abstract: This CDC Net useful resource supplies steerage on the regulatory necessities for SARS-CoV-2 POC testing, utilizing POC checks safely, and knowledge on reporting POC check outcomes.

Regulatory Necessities for POC Testing

Who can do POC testing?

Websites that carry out POC testing are required to have a Scientific Laboratory Enchancment Amendments (CLIA) certificates; discover data in this brochurepdf icon. There are 4 various kinds of CLIA certificates, any one among which is suitable for POC testing. See this Facilities for Medicare & Medicaid Companies (CMS) docpdf icon that describes the various kinds of CLIA certificates. A CLIA Certificates of Waiver is suitable for POC testing and will be obtained as follows:

  1. Full an software (Kind CMS-116pdf icon), obtainable on the CMS CLIA web siteexterior icon or from an area State Company.
  2. Ship the finished software to the handle of the native State Companyexterior icon for the state the place testing shall be carried out.
  3. Pay the CLIA Certificates of Waiver price, following directions supplied by the State Company.

See The way to Get hold of a CLIA Certificates of Waiverpdf icon for extra data. POC testing could also be carried out after the laboratory or testing website has obtained a CLIA certificates quantity.

The laboratory or testing website should hold its certificates data present. The State Company ought to be notified of any adjustments to the laboratory or testing website possession, identify, handle, or director inside 30 days.

What checks can be utilized for POC?

See the US Meals and Drug Administration (FDA) web site for an inventory of the SARS-CoV-2 POC checks which have obtained Emergency Use Authorization (EUA)exterior icon. Exams which were approved to be used in a POC setting can have a W, for Waived, within the Licensed Settings column of the FDA desk. The laboratory or testing website should use a check approved for POC use by FDA and should comply with the producer’s directions for every POC check. The directions to be used present particular data on find out how to carry out the check, which specimens can be utilized, and the people who could also be examined. The entire at the moment approved checks are approved to be used on symptomatic people. Nevertheless, CMS has indicatedpdf icon that CLIA will quickly enable CLIA laboratories and different CLIA testing websites to make use of SARS-CoV-2 POC antigen checks on asymptomatic people at some point of the COVID-19 public well being emergency.

For extra data and extra assets for POC testing, see CDC’s Waived Exams Net web page.

On March 26, 2020, CMS issued a memorandumexterior icon for surveyors and laboratories, offering steerage that included expedited evaluate of CLIA certificates functions throughout the COVID-19 public well being emergency.

Throughout the COVID-19 public well being emergency, the Facilities for Medicare & Medicaid Companiesexterior icon (CMS) permits a laboratory or testing website to make use of its current Certificates of Waiver to function a brief COVID-19 testing website in an off-site location, equivalent to a nursing residence or drive-through location. A brief COVID-19 testing website can solely carry out waived COVID-19 checks and should be beneath the path of the prevailing laboratory or testing website director.

Specimen Assortment & Dealing with of Level-of-Care Exams

There are various completely different FDA-authorized SARS-CoV-2 checks for POC settings. Every has been approved to be used with sure specimen sorts. Every POC check ought to solely be used with its approved specimen kind. Correct specimen assortment and dealing with is vital for all COVID-19 testing, together with these checks carried out at POC settings. A specimen that isn’t collected or dealt with accurately could result in inaccurate or unreliable check outcomes. For extra normal details about the right assortment of every of the specimen sorts, please seek advice from CDC’s Interim Tips for Amassing, Dealing with, and Testing Scientific Specimens for COVID-19.

Additionally it is necessary to make use of correct an infection management practices when accumulating and dealing with specimens for COVID-19 for POC testing. Each time potential, after accumulating the specimen, preserve at the least six ft of separation from the individual whose specimen was collected. CDC recommends utilizing Customary Precautionspdf icon when accumulating and dealing with specimens for POC testing. Customary Precautions embrace, however are usually not restricted to, private protecting gear (PPE), equivalent to a laboratory coat, surgical masks or face protect, disposable gloves, and eye safety.

As well as, CDC recommends the next practices when performing POC checks:

  • Carry out a danger evaluation earlier than testing to establish what might go improper, equivalent to inhaling infectious materials or touching contaminated objects and surfaces. Then
  • Comply with all the producer’s directions for performing the check within the actual order specified.
  • Carry out common high quality management and instrument calibration in accordance with the producer’s directions. If high quality management or calibration fails, establish and proper points previous to continuing with affected person testing.
  • Don’t reuse used check units, reagent tubes, options, or swabs.
  • Discard checks and check parts which have exceeded the expiration date or present indicators of harm or discoloration (equivalent to reagents displaying any indicators of alteration).
  • Change gloves between specimen assortment and after including specimens to the testing machine.
  • Retailer reagents, specimens, equipment contents, and check units in accordance with the producer’s directions, discovered within the bundle insert.
  • Reagents, check units, and cassettes shouldn’t be opened till the check course of is about to happen. Confer with the producer’s directions to see how lengthy a reagent, check machine, or cassette can be utilized after opening.
  • If the instrument permits for batch testing, develop a plan earlier than testing begins to make sure that reagents, check machine, cassette, and specimens are used inside time durations specified by the check producer.
  • If utilizing an instrument to carry out testing, decontaminate the instrument after every use; comply with the producer’s suggestions for utilizing an accepted disinfectant, together with correct dilution, contact time, and protected dealing with.
  • Learn and report outcomes solely throughout the period of time specified within the producer’s directions. Don’t report outcomes from checks that haven’t been learn throughout the producer’s specified timeframe.
  • Deal with laboratory waste from testing suspected or confirmed COVID-19 affected person specimens as all different biohazardous waste within the laboratory. At the moment, there is no such thing as a proof to recommend that laboratory waste wants extra packaging or disinfection procedures.

Laboratories and testing websites can discover free, on-line coaching programs related to working with COVID-19 specimens on CDC’s Getting ready and Supporting Laboratories Responding to COVID-19 Net web page.

Reporting Necessities for Level-of-Care Testing

A CLIA-certified laboratory or testing website should report all COVID-19 diagnostic and screening check outcomes to the person who was examined or that particular person’s healthcare supplier. Relying on the check producer’s directions to be used, which will be discovered at FDA’s EUA web siteexterior icon, the laboratory or testing website could also be required to report a damaging check consequence as a “presumptive damaging.”

A CLIA-certified laboratory or testing website should additionally report all COVID-19 check outcomes to their respective state, native,  tribal, or territorial well being division in accordance with the Coronavirus Assist, Aid, and Financial Safety (CARES) Act; seek advice from the CMS interim closing rule for regulatory reporting necessitiespdf icon. As well as, laboratories and testing websites can discover out extra about The way to Report COVID-19 Laboratory Knowledge.

CMS-certified long-term care amenities are required by the Division of Well being and Human Companiespdf icon (HHS) to make use of the Nationwide Healthcare Security Community (NHSN) to report SARS-CoV-2 point-of-care antigen check knowledge, and different on-site COVID-19 laboratory testing knowledge, to acceptable federal and state well being authorities.

Steadily Requested Questions on POC Testing

Understanding and Utilizing Customary Precautions

Use Customary Precautions when dealing with specimens that shall be examined for SARS-CoV-2. Specimens ought to be labeled with acceptable data to definitively join every specimen to a affected person. When transferring specimens from a group space to a testing space, comply with the directions for the POC check used.

Customary Precautions embrace:

  • Performing hand hygiene
  • Cleansing and disinfecting environmental surfaces
  • Conducting site-specific danger assessments for using acceptable private protecting gear (e.g., gloves, robes, face masks or respirators, eye safety) primarily based on actions being carried out
  • Minimizing potential exposures (e.g., respiratory hygiene and cough etiquette)

Customary Precautions are the essential practices that apply to all affected person care, whatever the affected person’s suspected or confirmed infectious standing, and apply to all settings the place care is delivered. These practices defend healthcare personnel and forestall healthcare personnel or the setting from transmitting infections to different sufferers.


Carrying Private Protecting Gear (PPE)

Use a brand new pair of gloves every time a specimen is collected from a special individual. If specimens are examined in batches, additionally change gloves earlier than placing a brand new specimen right into a testing machine. Doing so will assist to keep away from cross-contamination.

Disinfecting Work Surfaces

Use an Environmental Safety Company (EPA)-registered disinfectant from Record N: Disinfectants for Coronavirus (COVID-19)exterior icon. Comply with the producer’s suggestions to be used, equivalent to dilution, contact time, and protected dealing with.

For normal directions about utilizing EPA-registered disinfectants, seek advice from EPA’s 6 Steps for Secure & Efficient Disinfectant Usepdf icon.

One of the vital generally obtainable disinfectants is bleach. Use bleach containing 5.25%–8.25% sodium hypochlorite and put together a 1:10 diluted bleach answer. Comply with the producer’s software directions for the floor, making certain a contact time of at the least 1 minute.

For extra normal directions about utilizing diluted bleach options, seek advice from the assets under.


  1. Examine the label to make sure the bleach accommodates 5.25%-8.25% sodium hypochlorite. If there is no such thing as a label or the bleach is previous the expiration date, don’t use it.
  2. For each 9 elements of water, add 1 a part of bleach.
  3. Maintain the answer in a closed container when not in use.
  4. Label the container with the time and date the answer was made.
  5. After 24 hours, discard the remaining diluted bleach answer and make a brand new batch.
  6. By no means combine family bleach with ammonia or another cleaner because the ensuing fumes may cause severe hurt.

Useful resource

Cleansing and Disinfection for Households

Disinfect surfaces inside 6 ft of the specimen assortment and dealing with space at these occasions:

  • Earlier than testing begins every day
  • Between every specimen assortment
  • At the least hourly throughout testing
  • When visibly dirty
  • Within the occasion of a specimen spill or splash
  • On the finish of each testing day

Disinfect surfaces earlier than, throughout, and after testing.

  • Guarantee correct air flow throughout and after software of disinfectant, so nobody inhales fumes from the disinfectant.
  • All the time put on gloves acceptable for the chemical substances getting used if you end up cleansing and disinfecting. Further private protecting gear (PPE) could also be wanted primarily based on setting and product. For extra data, see CDC’s web site on Cleansing and Disinfection for Group Amenities.
  • Use an Environmental Safety Company (EPA)-registered disinfectantexterior icon when disinfecting surfaces the place specimens are collected and processed. Comply with the producer’s software directions to be used, equivalent to dilution, contact time, and protected dealing with.
  • Disinfect surfaces the place specimen assortment, dealing with, and testing happen. Examples embrace tables, chairs, and mattress frames.

You will need to comply with these suggestions to keep away from cross-contamination and hold employees protected.


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