Updated May 7th, 2020


MicroGenDX Helix With many labs at capacity and test turn-around times slowing down, MicroGenDX has validated its own Lab Developed CORONAVIRUS SARS-CoV-2 COVID-19 Test and is ready to assist.


FDA EUA Authorized | as of 4-23-20

View Authorization Letter

Listed under High Complexity Molecular-Based Laboratory Developed Tests as "Southwest Regional PCR Laboratory LLC. dba MicroGen DX" - View List


Nasal swab collection and transport materials are in high demand but in low supply causing many delays for tens of thousands of patients to even get tested for COVID-19. MicroGenDX has foreseen this bottleneck and has been validated for nasal swabs, sputum, and saliva testing for SARS-CoV-2. Sputum which is defined as saliva and mucus, has been shown to be equivalent to nasal swabs and in some studies superior to nasal swabs in the detection of SARS-COV-2. See proof sources below:

Sputum and Saliva as viable sample for COVID-19


Coronavirus saliva tests could be as accurate or better than nasal swabs, Yale researchers say

Saliva is more sensitive for SARS-CoV-2 detection in COVID-19 patients than nasopharyngeal swabs

Consistent Detection of 2019 Novel Coronavirus in Saliva

Detection of SARS-CoV-2 in Different Types of Clinical Specimens

SARS-CoV-2 RNA more readily detected in induced sputum than in throat swabs of convalescent COVID-19 patients

Could SARS-CoV-2 be transmitted via speech droplets?


  • MicroGenDX is a CLIA/CAP certified high complexity lab with more than 10 years experience designing molecular based laboratory developed tests (LDTs).
  • MicroGenDX Laboratories, the world leader in providing PCR and Next Generation DNA Sequencing in microbial identification, has validated a real-time Reverse Transcriptase PCR (rRT-PCR) assay for the specific detection of the SARS-CoV-2 virus. MicroGenDX has been validated for nasal swabs, sputum, and saliva samples for COVID-19 testing.
  • MicroGenDX Laboratory COVID-19 Testing Status and Approval for Diagnostic Testing for SARS-CoV-2 using Nasal Swabs, Sputum and Saliva Samples. READ MicroGenDX Regulatory Stance
  • As of March 23rd MicroGenDX has validated a real-time Reverse Transcriptase PCR (rRT-PCR) assay for the specific detection of the SARS-CoV-2 virus. The assay validation exceeds the minimum recommendations put forth by the FDA guidance policies and has been determined to be 100% specific and sensitive in vitro. CLICK HERE to Review MicroGenDX SARS-CoV-2 Molecular Diagnostic Validation Summary.
  • We have been validated and added to the FDA Website as a resource laboratory for COVID-19 Testing. Under the question: What Laboratories and Manufactures are offering Tests for COVID-19? Click the 3rd question down: "What laboratories are offering testing under the policy outlined in section IV.A of the policy for Diagnostic Tests for Coronavirus Disease-2019?" In the dropdown list of approved labs we are listed as Southwest Regional PCR Laboratory dba MicroGenDX. View FDA website
  • MicroGenDX is the most experienced molecular diagnostic laboratory for infectious disease having run more than 400,000 DNA tests over the last 12 years.
  • MicroGenDX’s COVID-19 Rapid PCR Test has a 24-72 hour turn around time from time of receipt.
  • MicroGenDX laboratory has been validated to offer the COVID-19 TEST utilizing nasal swabs, sputum and saliva samples. Sputum and saliva collection has been shown to deliver better results and is far less invasive than swab collection methods. Lancet, SARS-CoV-2 RNA more readily detected in induced sputum. Read Lancet Paper Here
  • MicroGenDX will have the capacity to process 6,000 samples per day.

Pricing



Due to limited number of swabs and VTM nationally, our collection kits will be distributed on a first come first serve basis.

If you, as a physician have signed off on a Provider Service Agreement, we can send a kit directly to your patients home for at home sampling and shipping to our laboratory. If not, ask your local MicroGenDX representative for details.


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