The Centers for Disease Control has recently developed a new laboratory kit that tests patient specimens for the 2019 novel coronavirus and Public Health has put in a request for these test kits to establish testing here on Guam.
At this time, all testing for 2019-nCoV is still completed at the CDC in Atlanta, Georgia.
On Feb. 5, 2020, the CDC began shipping the 2019-nCoV diagnostic test kits to U.S. domestic laboratories and select international laboratories. The Department of Public Health and Social Services wants Guam to be included in the list of recipients.
According to CDC, distribution of the tests will help improve the global capacity to detect and respond to the 2019 novel coronavirus.
The test kit, called the Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel, is designed for use with an existing RT-PCR testing instrument that is commonly used to test for seasonal influenza.
The CDC 2019 novel coronavirus test is intended for use with upper and lower respiratory specimens collected from people who meet CDC criteria for 2019-nCoV testing.
The test uses a technology that can provide results in four hours from initial sample processing to result.
According to CDC, the test kit has not been FDA-cleared or approved. However, distribution and use of the test kits follows the U.S. Food and Drug Administration February 4, 2020, issuance of an Emergency Use Authorization.
The tests are being shipped through the International Reagent Resource, a CDC-established mechanism that distributes laboratory reagents domestically and globally.
Initially, about 200 test kits will be distributed to U.S. domestic laboratories and a similar amount will be distributed to select international laboratories.
Each test kit can test approximately 700 to 800 patient specimens. Additional test kits will be produced and made available for ordering in the future from the IRR. At this time, each laboratory that places an order will receive one 2019-nCoV test kit.
The IRR is also accepting orders for 2019-nCoV tests from qualified laboratories. This includes 115 qualified U.S. laboratories, such as state and local public health laboratories and Department of Defense laboratories, as well as 191 qualified international laboratories, such as the World Health Organization Global Influenza Surveillance Response System laboratories.
According to CDC, the test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of 2019-nCoV, unless the authorization is terminated or revoked sooner.
Meantime, DPHSS continues to follow established protocols and CDC-provided criteria for determining whether or not a patient should be considered as a Patient Under Investigation for the coronavirus.
Guam medical providers have stepped up to the challenge, and are reaching out to Guam DPHSS to discuss and evaluate suspicious cases.
So far, no patients on Guam have met the PUI criteria for 2019-nCoV.
DPHSS said it continues to collaborate with providers and facilities to provide updates and review procedures for evaluating patients.