Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay
- GTR Test IDHelpEach Test is a specific, orderable test from a particular laboratory, and is assigned a unique GTR accession number. The format is GTR00000001.1, with a leading prefix 'GTR' followed by 8 digits, a period, then 1 or more digits representing the version. When a laboratory updates a registered test, a new version number is assigned.: GTR000592448.2
- Last updated: 2021-07-14
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- Test version history
Clinical microbial testHelpIn the U.S., clinical tests must be performed under CLIA certification. When a lab uses the same methods for a test in both clinical and research settings, the test appears as two separate GTR records. for Asymptomatic COVID-19
Offered by Ethos Laboratories
Overview
Test name
HelpThe name the laboratory assigns the test. Used as the default title of the page specific to the test.Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay (SARS-CoV-2 MALDI-TOF)
This is a clinical microbial test intended for HelpPurposes or indications for the test. Lab-provided.: Diagnosis
Click Indication tab for more information.
Contact the laboratory at GetTested@ethos-labs.com.
CPT Codes: PCR- U0004 & U0005
Order URL HelpLink to the laboratory webpage with information about how to order this test. Please note that clicking on this link will open a new tab in your internet browser.: https://www.ethos-labs.com/schedule-viral-test/
Specimen source
Sample requirements
Samples must be shipped overnightTurnaround time
48-72 hoursMethodology
HelpThe assay's major method category (biochemical, cytogenetic or molecular genetics); method category (i.e. enzyme assay, chromosome breakage studies, targeted mutation analysis); methodology (i.e. the name of the method used) and instruments used when performing this test.- Molecular Genetics
- RRNA analysis
- RT-PCR
- Agena MassArray
- MassArray SARS-Cov-2 Panel
Establish or confirm diagnosis
- Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape. - PubMed ID: 32729549
Clinical validity
HelpHow consistently and accurately the test detects or predicts the intermediate or final outcomes of interest. Lab-provided.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 detectedMinimal microbe load test can detect
1 TCID50/mL with 100% accuracy.Testing strategy
HelpThe lab's suggested sequence of ordering tests based on clinical scenarios. It may include information on: reflex testing including each test component, and scenarios which prompt additional components of testing; whether lab communicates interim results or automatically proceeds to further analyses; and if any components are performed in another laboratory.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
HelpLaboratory's order or catalog code for the test (used in the order requisition form).- Result interpretation, Order code: VR100, commentsAssist in testing validation and relevance of results
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