FDA authorises Abbott's COVID-19 assay for emergency use, while Qiagen's test kit for SARS-CoV-2 detection gains CE marking

Abbott announced on Thursday that the FDA issued an emergency-use authorisation (EUA) for the company's molecular test for COVID-19, adding that it is immediately shipping 150,000 RealTime SARS-CoV-2 tests to existing customers in the US. In addition, Qiagen announced that it is launching its QIAstat-Dx respiratory SARS-CoV-2 panel test in Europe after receiving CE marking as an in vitro diagnostic to detect the novel coronavirus.

According to Abbott, its test works on the company's m2000 RealTime platform, which uses PCR technology, and can run up to 470 tests in 24 hours. Abbott noted that more than 175 m2000 systems are used in hospital and reference laboratories, and it will be working with health systems and government authorities to deploy additional m2000 systems where needed. The company has already sent tests to hospital and academic medical centre laboratories in 18 states including Illinois, California, New York, Massachusetts and Washington, and said it will "continue ramping up production to the highest levels possible, with the goal of providing up to 1 million tests per week."

Meanwhile, Qiagen says that its QIAstat-Dx test kit, the first syndromic testing solution in Europe for use in the COVID-19 outbreak, can differentiate SARS-CoV-2, via a single testing run of about one hour, from 21 other serious respiratory infections in patients exhibiting similar symptoms. The multiplexed nucleic acid test evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. The newly approved panel includes assays targeting two genes used to detect SARS-CoV-2.

Last month, Qiagen announced worldwide shipments of QIAstat-Dx test kits for SARS-CoV-2. The kits run on the company's QIAstat-Dx analyser, a "sample-to-insight" syndromic testing system that "automates molecular analysis to deliver differential detection in about one hour." Qiagen said it has placed more than 1000 QIAstat-Dx instruments globally in hospitals, clinics and laboratories.

Thierry Bernard, interim CEO at Qiagen, remarked that "in addition to QIAstat-Dx, we are supplying RNA extraction kits under the QIAamp and EZ1 brands that have been recommended in current testing guidelines worldwide, as well as numerous components and instruments for use in fighting this public health crisis."  

Here is a non-exhaustive list of the status of some COVID-19 tests:

Abbott

RealTime SARS-CoV-2 assay

 

FDA EUA

Quest Diagnostics

Quest SARS-CoV-2 rRT-PCR

 

FDA EUA

Quidel

Lyra SARS-CoV-2 Assay

 

FDA EUA

LabCorp

COVID-19 T-PCR test

 

FDA EUA

Hologic

Panther Fusion SARS-COV-2 Assay

 

FDA EUA

Centers for Disease Control and Prevention

2019-nCoV RT-PCR Diagnostic Panel

 

FDA EUA

Wadsworth Center, NYSDOH

New York SARS-CoV-2 RT-PCR Diagnostic Panel

 

FDA EUA

Roche

cobas SARS-CoV-2

 

FDA EUA

Thermo Fisher

TaqPath COVID-19 Combo Kit

 

FDA EUA

BD/BioGX

BD MAX COVID-19 Test

 

FDA EUA

Co Diagnostics

Logix Smart COVID-19 test

 

Awaiting EUA; CE marked

Fulgent/MedScan

COVID-19 NGS Test

 

Awaiting EUA

Diatherix Eurofins

COVID-19 Panel

 

Awaiting EUA

Stanford Medicine

COVID-19 RT-PCR test

 

In-house LDT

UC San Diego Health System

COVID-19 Test

 

In-house LDT

Diasorin

Simplexa COVID-19 Direct Assay

 

In development

Opko Health

COVID-19 test

 

In development

Qiagen

QIAstat-Dx Respiratory 2019-nCoV Panel

 

CE marked

CerTest Biotec

Viasure COVID-19 test

 

CE marked

Genomica

CLART COVID-19 test

 

CE marked

Novacyt

COVID-19 test

 

CEmarked/RUO

BGI Genomics

RT-PCR test

 

Awaiting EUA, CE marked and used in China

GenMark

ePlex SARS_CoV-2 test 

RUO

 

 

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