Summary of recent changes

Updates as of April 4,

Click here to get more.

• HHS and CDC's new guidance no longer requires reporting of negative results for non-NAAT tests (rapid or antigen test results).
• This update also no longer requires reporting of antibody test results, positive or negative.
• The CLIA regulations requiring reporting of SARS-CoV-2 test results expired at the end of the PHE.
• Previous updates may be found in the Recent Updates section below.

Point-of-care testing

Point-of-care testing uses rapid diagnostic tests performed or interpreted by someone other than the individual being tested or their parent or guardian and can be performed in a variety of settings. Rapid tests used in point-of-care settings can be NAAT or antigen tests.

These tests can be used to diagnose SARS-CoV-2 infections in various point-of-care settings, including but not limited to:

• Physician offices
• Urgent care facilities
• Pharmacies
• School health clinics
• Long-term care facilities and nursing homes
• Temporary locations, such as drive-through sites managed by local organizations

Regulatory requirements for rapid testing in point-of-care settings

There are four types of CLIA certificates [47 KB, 1 page], any one of which is appropriate for point-of-care testing. A CLIA certificate is required to perform point-of-care testing. A CLIA Certificate of Waiver is appropriate if SARS-CoV-2 point-of-care testing is the only testing being performed. It can be obtained as follows:

1. Complete an application (Form CMS-116 [311 KB, 10 pages]
   ), available on the CMS CLIA website
   or from a local State Agency.
2. Send the completed application to the address of the local State Agency
   for the state where testing will be performed.
3. Pay the CLIA Certificate of Waiver fee, following instructions provided by the State Agency.

See How to Obtain a CLIA Certificate of Waiver [1.4 MB, 9 pages] for more information.

Laboratories or point-of-care testing sites that have applied for a CLIA Certificate of Waiver to perform SARS-CoV-2 point-of-care testing can begin testing and reporting SARS-CoV-2 results after receipt of the certificate, and as long as they meet any additional state licensure requirements that apply. The point-of-care testing site must keep its certificate information current. The State Agency should be notified of any changes to the laboratory or testing site ownership, name, address, or director within 30 days.

Centers for Medicare and Medicaid Services (CMS) has provided specific guidance for the use of FDA authorized OTC self-tests when these tests are either performed or the results are interpreted by someone other than the individual being tested or their parent or guardian. In these circumstances, the tests are not considered self-tests and the point-of-care testing site that performs the testing or interprets the test results needs a CLIA certificate.

Tests that can be used in point-of-care settings

Refer to the U.S. Food and Drug Administration (FDA) website for a list of the SARS-CoV-2 point-of-care and rapid tests that have received Emergency Use Authorization (EUA) and/or granted Traditional Marketing Authorization by FDA.

Tests that have been authorized for use in a point-of-care setting will have a W, for Waived, in the Authorized Settings column of the FDA table. The laboratory or testing site must use a test authorized for point-of-care use by the FDA and must follow the manufacturer's instructions for each test. The instructions for use provide specific information on how to perform the test, which specimens can be used, and the people who may be tested.

OTC tests can be purchased and used in a point-of-care setting. However, when these tests are either performed or the results are interpreted by someone other than the individual being tested or their parent or guardian, then the CLIA requirements for waived tests must be followed.

Reporting requirements for rapid testing in point-of-care settings

Depending on the test manufacturer's instructions for use, which can be found on FDA's EUA website or the Traditional Marketing Authorization website, the laboratory or testing site may report a negative test result as a "presumptive negative." Testing sites can find out more about reporting at CDC's How to Report COVID-19 Laboratory Data.

CMS-certified and other long-term care (LTC) facilities may submit point-of-care SARS-CoV-2 testing data, including antigen, antibody, and nucleic acid amplification test (NAAT) testing data, to CDC's National Healthcare Safety Network (NHSN). Test data submitted to NHSN is available to appropriate state, tribal, local, and territorial health departments.

Effective May 1, , hospitals are no longer required to report Hospital Respiratory Pathogen, Bed Capacity, and Supply Data (i.e., 'COVID-19 Hospital' data) to HHS through NHSN. However, given the value of these data for patient safety and public health, CDC strongly encourages ongoing, voluntary reporting of the data through NHSN.

On April 10, , CMS issued the fiscal year Medicare hospital inpatient prospective payment system and long-term care hospital prospective payment system proposed rule.

Within this rule, CMS is proposing to update the hospital and critical access hospital (CAH) infection prevention and control and antibiotic stewardship programs' Conditions of Participation (CoPs) to extend a subset of the currently discontinued COVID-19 and influenza data reporting requirements.

Specifically, CMS is proposing to replace the COVID-19 and Seasonal Influenza reporting standards for hospitals and CAHs with a new standard that will address acute respiratory illnesses.

This new standard would require that beginning on October 1, , hospitals and CAHs would have to electronically report certain data elements about COVID-19, influenza, and respiratory syncytial virus (RSV). The proposed information for which reporting would be required includes confirmed infections of respiratory illnesses, including COVID-19, influenza, and RSV, among hospitalized patients; hospital bed census and capacity; and limited patient demographic information, including age. CMS is proposing that, outside of a public health emergency PHE, hospitals and CAHs would have to report these data on a weekly basis.

Link to APC Med

Learn More About Performing Rapid Tests in Point-of-Care Settings

CDC has free training and tools to help you learn the basics about performing point-of-care testing. The companies that make the tests and testing systems also have free training resources designed to help you use the tests. Find links in this section to resources and training that will help you get ready to test.

CDC educational materials for rapid testing in point-of-care settings

Many COVID-19 point-of-care and rapid tests fall into a category called waived tests, which are tests performed in a laboratory or at a testing site under a CLIA Certificate of Waiver. CDC has free educational and training resources for waived point-of-care testing available at Waived Tests | CDC.

Recent updates

• Added language about reporting results of over-the-counter (OTC) tests when used in a point-of-care setting.

• Updated waste management guidance.

• Edited "Regulatory Requirements for Point-of-Care and Rapid Testing" section to add updated Centers for Medicare & Medicaid Services (CMS) guidance for SARS-CoV-2 point-of-care tests and Clinical Laboratory Improvement Amendments (CLIA) Certificates of Waiver.
• Added new training resources from manufacturers of SARS-CoV-2 point-of-care and rapid tests.
• Added a link to CDC's Biological Risk Management for Point-of-Care Testing Sites.

• Edited to add language about antibody testing.

• Edited "Specimen Collection and Handling Point-of-Care Tests" section to add language which clarifies the personal protective equipment (PPE) recommended for personnel collecting point-of-care (POC) specimens versus the PPE recommended for personnel handling POC specimens but not directly involved in collection and not working within 6 feet of patients.

• Added to whom staff at long-term care facilities (LCTFs) should report point-of-care antigen testing data under "Reporting Requirements for Point-of-Care Testing" section.

• Added a new "Help with Performing Point-of-Care Tests" section, which includes training resources for performing POC tests.

• Modified page to include Frequently Asked Questions about Point-of-Care Testing.

10 Features to Look for in a Test Kit

Deciding which test kit has the right features for your specific needs may be best determined by talking with an expert at your local retailer about these top ten features to consider when deciding which test kit is right for you!

1. EASE OF USE

Consider test kits that you feel comfortable using, one that doesn&#;t intimidate you. After all, a test kit that sits on a shelf &#; no matter how good its chemistry &#; is a waste of money. For example, having reagent caps color-coded to the instructions is a big help!

2. COMPLETENESS

A good test kit should contain tests for the following parameters:

• Sanitizer (chlorine or bromine) for health reasons
• pH for maintenance reasons
• Complete and easy-to-understand instructions
• Recommendations for each parameter tested

Better test kits have the above features PLUS:

• Can distinguish between &#;free chlorine&#; and &#;combined chlorine&#;
• Total alkalinity
• pH adjustment (acid and base demand tests)
• Treatment dosage table for determining the correct amount of product

The best, most complete test kits also have tests for:

• Calcium Hardness (for water balance determinations)
• Cyanuric acid (chlorine stabilizer)
• Room in the case to add additional reagents for other tests (e.g., sodium chloride)

3. ACCURACY

True and trusted test kit readings are a must for each parameter. Your best defenses against buying an inaccurate test kit are a reputable manufacturer whose testing systems have proven reliable over many years and a conscientious dealer/retailer who rotates his stock and trains the staff to sell the appropriate refill reagents. Test kits made by companies that manufacture other products than test kits may not be as dependable.

4. CONSISTENCY OF RESULTS

The primary purpose in testing is to catch changes in your pool or spa&#;s water chemistry before problems develop. So it is absolutely essential to be able to repeat tests accurately over periods or days, weeks, and even months.

5. TESTING METHOD SUITABLILTY

For any test kit to be trustworthy, you have to be able to easily translate the results to an effective treatment or maintenance action. All of which makes calculating treatment dosages easier and more accurate, so there are no more wasted treatment chemicals. Wasted treatment chemicals = less money in your pocket!

6. APPROPRIATE DESIGN

Liquid reagents should leave no waste or other materials to dispose of afterwards. Color standards are protected from bleaching and scratching. Fill marks are molded on and not painted. Cases should have ergonomic handles for easy transport.

7. DURABILITY

Can the test kit you have withstand repeated use in a wet environment? Two important indicators of a durable test kits are waterproof instructions and vinyl reagent labels.

8. AVAILABILITY

Although test kits and reagents can be purchased via the Internet, your best bet, from a cost perspective and a service perspective, is to purchase these products from a local reputable pool/spa retailer in your area. Most reputable pool/spa retailers only sell test kits and testing supplies from trusted manufacturers like Taylor Technologies, Inc.

9. RELIABLE MANUFACTURER

Select an appropriate test kit from a reliable manufacturer that has a proven history of producing quality, testing-related products. Taylor Technologies, Inc. has been manufacturing testing supplies and test kits, and nothing else, since .

10. VALUE

As with any type of purchase, it pays to comparison shop using price as one (but not the only one) of several determining factors. The kit with the best value for your needs may not necessarily be the least expensive. Remember, when compared to your overall investment, the right test kit is indispensable, regardless of the cost.

For more information, please visit Test Kit Manufacturer(uk,es,it).