Antigen (BinaxNow) rapid testing

Please note, on Friday, June 18, 2021, Kelly Keefe from DHHS Health Facilities Administration announced the following update regarding COVID-19 testing at senior residential facilities:

“The department has filed an emergency rulemaking to exempt nursing homes and residential care facilities from requiring a lab and/or collection station license to perform COVID-19 collections/testing on residents/staff/visitors.  Effective immediately, nursing homes and residential care facilities may resume COVID-19 collections/testing on residents/staff/visitors.

Q: What can I do with BinaxNOW rapid tests? 

A:  The BinaxNOW testing system is used to carry out rapid, point of care tests on “individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.” In addition to antigen testing information in HAN #23, NH DHHS issued antigen screening guidance and links to CDC’s considerations on antigen testing in nursing homes and you should consult these sources when making decisions about using BinaxNow.

The BinaxNOW testing system has important limitations, particularly: “Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.” More information from FDA.gov

Q:  How do I get BinaxNOW rapid test kits? and

Q: How do I get additional BinaxNOW rapid test supplies if I use up my initial batch? 

A:  From NH DHHS, “residential care providers throughout New Hampshire may now request BinaxNOW COVID-19 Rapid Antigen Test supplies at no cost from the NH Department of Health and Human Services. Use that same form to request additional supplies — regardless of the note on the drop down at that link, you may request more from the state (SST volunteers verified this with DHHS in late January 2021).

Note that you will need a CLIA Certificate to conduct testing using BinaxNOW kits in your facility and a NH state Laboratory license and a NH state Collection Station certificate. 

You can request a Letter of Waiver for the two state licenses by emailing DHHS.hfaregcorrespondence@nh.gov. Include the administrator name, facility name, address, and facility license number and state clearly that you are requesting a Letter of Waiver for the state Laboratory license and Collection Station certificate. 

You can find the CLIA Certificate application, Form CMS-116, here: www.cms.gov/Medicare/CMS-Forms/CMS-Forms/CMS-Forms-Items/CMS012169 

Completed CLIA applications should be submitted by email to clia@dhhs.nh.gov. Many senior residential facilities will want to apply for a CLIA Certificate of Waiver (CMS-116 Section II, “Type of Certificate Requested”).   

Q:  How do I report BinaxNOW rapid test results? 

A:  DHHS provides an online form where you can submit point-of-care COVID test results.

See also: Employee (staff) testing, Residents, Surveillance testing

This page updated 6/24/21

Information is changing rapidly as the COVID-19 outbreak evolves. Please take the links on these pages, especially the NH DHHS, which coordinates the COVID-19 response in our state, and other public health resources such as your local public health department, the CDC and WHO to find the latest guidance and recommendations.

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