California Company's Test Provides COVID-19 Results In Less Than an Hour

By Andrea Ano Mar 23 2020, 08:10 AM EDT

Materials for a rapid test kit for coronavirus (COVID-19) are displayed at a laboratory in Ankara — Reuters

In a recent press release by the FDA, they confirmed the approval of a test kit that provides results in hours instead of days. The test kit is called Cepheid Xpert Xpress SARS-CoV-2 from the pharmaceutical company Cepheid Inc.

Alex Azar, Health and Human Services Secretary, is positive that with new diagnostic tools that can provide faster results, making it easier for Americans to get tested.

How do the Cepheid Xpert Xpress SARS-CoV-2 tests work?

The pharmaceutical company based in Sunnyvale, California, confirms that the test kits can provide results in less than 45 minutes.

The test starts with the collection of a biological sample of the patient, either through a nasopharyngeal swap or nasal wash. Next, the sample is mixed in a tube then transferred to a Cepheid cartridge along with a pipette. The cartridge already includes testing reagents for the virus.

The cartridge is placed on a GeneXpert Machine which identifies if the patient has been infected by the virus or not. It is designed to detect nucleic acid from SARS-CoV-2 via polymerase chain reaction. The machine comes in different sizes with the largest being able to test 80 samples simultaneously.

Warren Kocmond, President of Cepheid Inc., said that the machines can be easily used by anyone and is able to perform round the clock. The test kits are expected to be shipped out on March 27 and rolled out by March 30.

The FDA's emergency authorization allows unapproved products to be used during a public health crisis. Other test kits have been granted with emergency authorization but Cepheid's test kit is, by far, the only product that delivers results in less than an hour.

Roche began shipping 400,000 CoVid-19 test kits last week under the FDA's Emergency use Authorization. The company plans to continue shipping their self-manufactured kits every week to help with the testing.

FDA Alerts the Public on Fraudulent Test Kits

The increase in confirmed Covid-19 cases has driven the public to get tested as soon as they have flu-like symptoms or suspected to have been in contact with someone who is infected. Some may purchase test kits for at-home use which the FDA has not authorized yet.

The agency is serious when it comes to protecting the public's health safety thus they continue to monitor firms suspected of marketing Covid-19 test kits for home use. They are still working with developers to make at-home test kits available to the public but so far, they have not granted emergency use authorization to any.

The FDA further reminds the public to follow the Center for Disease Control and Prevention's guidelines and seek medical attention if they suspect themselves or anyone they know to be infected by coronavirus.

The agency had issued warning letters to identified companies selling fraudulent items and is now looking into enhanced enforcement at ports of entry to reduce the count of these products from entering US Territory.

They further encourage the public to report any possible fraudulent Covid-19 test kits to them. Moreover, The President's Coronavirus Guidelines for America provides information on how individuals and families can help in slowing the spread of the pandemic virus.