Integrity Laboratories Covers New COVID-19 Variants

Integrity Laboratories Covers New COVID-19 Variants

According to the World Health Organization (WHO) new variants of SARS-CoV-2 virus are highly contagious and have now spread to over 80 countries. As they continue to mutate, the early detection of infected individuals with SARS-CoV-2 virus within our communities is critical to prevent the transmission of COVID-19 disease.

Our COVID-19 test by Integrity Laboratories successfully detects original as well multiple new mutant variants of SARS-CoV-2 virus, including Delta variant and 2 additional mutants originated from India, Mu and Lamda.

In our results reports of our COVID-19 test, we provide Viral Load IndicatorTM (VLITM) values, in addition to results for detection of SARS-CoV-2 virus. VLITM achieved by AmpliteCtTM is a quantitative method that can broadly categorize the concentration of SARS-CoV-2 virus genetic material in patients using RT-PCR technology.

The current list of CDC recognized variants can be properly detected through our intercept PCR(™) platform.

  • Alpha (B.1.1.7 and Q lineages)
  • Beta (B.1.351 and descendent lineages)
  • Gamma (P.1 and descendent lineages)
  • Epsilon (B.1.427 and B.1.429)
  • Eta (B.1.525)
  • Iota (B.1.526)
  • Kappa (B.1.617.1)
  • 1.617.3
  • Mu (B.1.621, B.1.621.1)
  • Zeta (P.2)
  • Delta (B.1.617.2 and AY lineages)
  • Omicron
  • To date, no variants of high consequence have been identified in the United States.

 

SARS-CoV-2 Delta Variant Detected by Integrity Laboratories FDA EUA approved Assay

9 Viral Variants | 3 Viral Load Indicators | 1 RT-PCR Test

NIH GenBank® ID GISAID Name
MT007544.1 Australia/VIC01/2020
MN908947.3 Wuhan-Hu-1
LC528232.1 Japan/Hu_DP_Kng_19-020/2020
MT106054.1 USA/TX1/2020
MT188340 USA/MN2-MDH2/2020
MT118835 USA/CA9/2020
EPI_ISL_710528 England/205041766/2020
EPI_ISL_601443 England/MILK-9E05B3/2020

(Synthetic Viral Controls | Twist Bioscience, 2021)

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Integrity Laboratories began testing for SARS-CoV-2 (COVID-19) under Emergency Use Authorization (EUA) on March 23.

Please direct all inquiries to covid19@integritylaboratories.com for immediate review.

FDA Authorization Letter   |   FDA EUA Summary

CARES Act Statement