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Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay

  • GTR Test IDHelp: GTR000592448.2
  • Last updated: 2023-03-02
  • Test version history

Clinical microbial testHelp for Asymptomatic COVID-19
Offered by Ethos Laboratories

Overview

Test order codeHelp: VR100

Test name

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Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay (SARS-CoV-2 MALDI-TOF)

Purpose of the test

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This is a clinical microbial test intended for Help: Diagnosis

Condition

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Click Indication tab for more information.

How to order

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Contact the laboratory at GetTested@ethos-labs.com. CPT Codes: PCR- U0004 & U0005
Order URL Help: https://www.ethos-labs.com/schedule-viral-test/

Specimen source

Nasal swab
Nasopharyngeal (NP) swab
Oropharyngeal swab
Saliva
Specimen requirements: https://www.fda.gov/media/140780/download

Sample requirements

Samples must be shipped overnight

Turnaround time

48-72 hours

Methodology

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Molecular Genetics
RRNA analysis
RT-PCR
  • Agena MassArray
  • MassArray SARS-Cov-2 Panel

Summary of what is tested

Click Methodology tab for more information.

Clinical utility

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Establish or confirm diagnosis

Citations
  • Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape. - PubMed ID: 32729549

Clinical validity

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A total of 107 clinical nasopharyngeal swab specimens (54 negatives and 53 positives for SARS-CoV-2) were tested with the Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay and the results were compared to results obtained with the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (EUA200001). Samples were extracted using the KingFisher Flex Purification System, reverse transcription RT-PCR was performed using the Veriti 96 Thermal Cycler and MALDI-TOF spectrometry was performed on the Agena MassARRAY System. Total Percent Agreement was 104/107 = 97.2%.

Citations

Not provided

How long can the microbe be present after therapy (rendering consequent tests meaningless)

The SARS-CoV-2 virus can be detected up to 56 hrs. following sample collection.

Comments about the test interpretation (e.g. clinical implication of test results)

1. Negative: RNase P detected, all SARS-CoV-2 targets not detected 2. Positive: RNase P detected or not detected, two or more SARS-CoV-2 targets detected 3. Inconclusive: RNase P detected or not detected, only one SARS-CoV-2 target detected 4. Invalid: RNase P not detected, all SARS-CoV-2 targets not detected

Minimal microbe load test can detect

1 TCID50/mL with 100% accuracy.

Testing strategy

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SARS-CoV-2 MALDI-TOF Assay of nucleic acid sequences from the genome of the SARS-CoV-2 [N1, N2, N3, ORF1, and ORF1ab genes] for in vitro qualitative detection of COVID-19 in samples. All testing performed on-site at Ethos Labs. 000 Contact the laboratory at GetTested@ethos-labs.com. CPT Codes: PCR- U0004 & U0005

Test services

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  • Result interpretation, Order code: VR100, comments

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