COVID-19 Test
Accurate, Fast Results

ABOUT PSOMA COVID-19 RT CORONAVIRUS TEST

The Psoma COVID-19 RT Test from Psomagen is an in-vitro lab developed test (LDT) that uses real-time reverse transcription-polymerase chain reaction (RT-PCR) to detect RNA of the SARS-CoV-2 nucleocapsid gene (N1 and N2 target) and the RNaseP gene in upper respiratory and bronchoalveolar lavage specimens.

The method used increases the accuracy of the test results, effectively screening patients with trace amounts of COVID-19. The COVID-19 test from Psomagen is easy to administer and provides fast results. Laboratories certified under CLIA can conduct this PCR coronavirus test in-house. Laboratories in the U.S. and its territories are required to report all results to the appropriate public health authorities.

The FDA granted the Psoma COVID-19 RT Test Emergency Use Authorization on June 30, 2020. During Psomagen’s clinical trials for the tests, the company confirmed 100% consistency in 30 samples each in the positive and negative groups. The samples were collected from the upper and lower airways of COVID-19 patients.

THE PSOMA COVID-19 RT TESTING FROM PSOMAGEN

  • FDA-approved coronavirus test for Emergency Use Authorization
  • In-vitro diagnostic use
  • Confirms presence of COVID-19 in two hours

Benefits of Psoma COVID-19 RT Coronavirus Test

  • Simple and rapid detection
  • Ability to identify trace amounts of COVID-19
  • Reliable and accurate system

FOUR-STEP TESTING PROCESS

Collect specimen using nasopharyngeal, oropharyngeal, or nasal swabs

Collect specimen using nasopharyngeal, oropharyngeal, or nasal swabs

Isolate and purify nucleic acids from upper respiratory and bronchoalveolar lavage specimens using NucleoSpin RNA Virus

Reverse transcribe purified nucleic acid into cDNA and amplify nucleic acid in LightCycler 480 using the TOPreal One-step RT qPCR kit

Interpret results

Interpret results

Each step, including specimen collection, storage and transportation, and laboratory testing, should be conducted in accordance with biosafety regulations. Only qualified clinical laboratory personnel who are trained in real-time PCR and in-vitro diagnostic procedures should perform the tests.

ABOUT EUA

The Psoma COVID-19 RT Test is an FDA-approved coronavirus test for Emergency Use Authorization. The FDA permits Emergency Use Authorizations (EUAs) for unapproved medical products during public health emergencies when there are no suitable alternatives. An EUA is different from an FDA-cleared product.

The HHS Secretary determined the presence of a public health emergency due to COVID-19 on Feb. 4, 2020, and subsequently approved emergency use authorizations for in-vitro diagnostics to detect and diagnose coronavirus.

FACT SHEET FOR PATIENTS

FACT SHEET FOR HEALTHCARE PROVIDERS

  • This test has not been FDA cleared or approved; 
  • This test has been authorized by FDA under an EUA for use by the authorized laboratory; 
  • This test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens; and 
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.