COVID 19 Virus Testing-RT-PCR (Thermo-Taq path kit)
- 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.: GTR000593852.1
- Last updated: 2021-08-25
- Annual Review past due read more
- Test version history
- 593852.1, last updated: 2021-08-25
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 COVID-19
Offered by KSL Diagnostics
Overview
Test name
HelpThe name the laboratory assigns the test. Used as the default title of the page specific to the test.COVID 19 Virus Testing-RT-PCR (Thermo-Taq path kit)
This is a clinical microbial test intended for HelpPurposes or indications for the test. Lab-provided.: Diagnosis
Click Indication tab for more information.
CPT Code: U004
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.ksldx.com/covid-19-pcr-test
Specimen source
Sample requirements
For swabs in viral transport medium or ESwab™: Oropharyngeal (OP) samples: Swab included in viral transport medium or ESwab™ is acceptable for submission. Nasopharyngeal (NP) samples: Use separate NP swab submitted in viral transport medium (discard OP swab included with viral transport medium or ESwab™). Exact manufacturer of the swab and transport medium may vary with supply. Any swab of appropriate size and configuration with a synthetic tip can be used except for calcium alginate tips, swabs with preservatives, and swabs with wood shafts. Viral transport medium acceptable for collection of influenza specimens in 1 mL or 3 mL volumes can be used to transport swabs for COVID-19 testing. For swabs in saline: OP or NP swabs may be placed in 1 to 3 mL of sterile saline (0.85 to 0.9%) in a sterile screw cap container. Do not use vacutainer or "pop-top" tubes. Any swab of appropriate size and configuration with a cotton or synthetic tip can be used except for calcium alginate tips, swabs in preservatives, and swabs with wood shafts. Sterile cups are acceptable for OP or NP washes/aspirates, bronchial washings, or bronchoalveolar lavage (BAL) specimens. Transport Conditions: ship on cool packs 2°-8° C. Specimen Storage Frozen at -20° C (preferred). Refrigerated specimens acceptable (if received for testing within 72 hours of collection). Room temperature swabs are acceptable (if received within 24 hours of collection). Rejection criteria: - Cotton-tip swabs in Urinary or Vaginal transport media - Refrigerated samples greater than 72 hours old - Room temperature swabs greater than 24 hours old - Improperly labeled, grossly contaminated, broken or leaking transport device - Collection with substances inhibitory to PCR including heparin, hemoglobin, ethanol, EDTA concentrations >0.01M - Specimens submitted in glass tubes/containersTurnaround time
less than 24 hourssMethodology
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
Not provided
Clinical validity
HelpHow consistently and accurately the test detects or predicts the intermediate or final outcomes of interest. Lab-provided.Not provided
Comments about the test interpretation (e.g. clinical implication of test results)
A Detected result indicates that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA is present and suggests the diagnosis of coronavirus disease 2019 (COVID-19). Test result should always be considered in the context of patient’s clinical history, physical examination, and epidemiologic exposures when making the final diagnosis. An Undetected result indicates that SARS-CoV-2 is not present in the patient’s specimen. However, this result may be influenced by the stage of the infection and the quality of the specimen collected for testing. An Indeterminate result suggests that the patient may be infected with a variant SARS-CoV-2 or SARS-related coronavirus. Additional testing with an alternative molecular method is recommended on a newly collection specimen. An Inconclusive result indicates that the presence or absence of SARS-CoV-2 RNA in the specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to RT-PCR inhibition. Submission of a new specimen is recommended.IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.