Test Procedure
The WSU MDL is an open lab system allowing the flexibility to use multiple reagents
and testing protocols. Currently, MDL is using the following Molecular genetic active
virus testing protocols using RT-PCR.
Thermo Fisher Scientific, Inc. TaqPath™ COVID-19 Combo Kit
The Thermo Fisher TaqPath™ “Gold Standard” first utilizes a nucleic acid extraction
step and then evaluates three different sequence targets of the viral genome. It
currently requires a nasopharyngeal, oropharyngeal, or anterior nares swabbing placed
in Viral Transport Media. Specificity is essentially 100% and sensitivity is essentially
100% as well.
Yale School of Public Health, Department of Epidemiology of Microbial Diseases, SalivaDirect™
SalivaDirect™ is non-extraction method and evaluates a single nucleic acid sequence target on the
Coronavirus genome. This requires one ml of saliva in a sterile tube provide to healthcare
professionals by the MDL. Specificity is essentially 100% and sensitivity approximately
94.6%.
Thermo Fisher Scientific TaqPath ™
- FDA EUA approved for use on all CDC approved respiratory specimens (such as nasopharyngeal,
oropharyngeal, nasal, and mid-turbinate swabs, nasopharyngeal aspirate and bronchoaveolar
lavage (BAL) specimens)
- The gold standard for testing: full viral RNA extraction on the KingFisher'" Flex
with real-time reverse transcription polymerase chain reaction (RT-PCR) on the QuantStudio
7
- Coming soon: Multiplex Assay: allows for detection of
SARS-CoV-2, Influenza A, Influenza B, and RSV from
one analyzed specimen
- Coming soon: Addition of approved saliva specimen for infection detection.
- Targets 3 different regions of the viral genome
- Testing Specificity: 100%
- Testing Sensitivity: 100%
- FDA Emergency Use Authorization
- Healthcare Provider Fact Sheet (US)
- Patient Fact Sheet (US)
-
FDA EUA approved for saliva specimens collected in sterile cups or tubes without addition
of any preservatives providing greater ease in sample collection.
- Extraction-free RT-PCR: Proteinase K heat treatment followed by real time reverse
transcription polymerase chain reaction (RT-PCR) on the Applied Biosystems 7500 Fast
Dx
-
Utilizes combinations of alternate and substitute reagents, at each step adding redundancy
and flexibility in the supply chain.
- Enables non-invasive, frequent sampling and reduces the need for trained healthcare
professionals during collection
-
Targets 1 region of the viral genome
- Testing Specificity: 100%
- Testing Sensitivity: 94.6%
- FDA Emergency Use Authorization
- Healthcare Provider Fact Sheet (US)
- Patient Fact Sheet (US)
MDL RSV/Influenza/COVID-19 (RIC) Assay
The MDL RIC test utilizes the "gold standard" for viral PCR testing. First, nucleic
acid extraction is performed followed by RT-PCR that looks for multiple viruses in
the sample. This test requires nasopharyngeal, oropharyngeal, or anterior nares swab
placed in viral transport media. Specificity is essentially 100% and sensitivity is
>97%.
- Approved for use on all CDC approved upper respiratory specimens (such as nasopharyngeal,
oropharyngeal, and mid-turbinate swabs)
- The gold standard for testing: full viral RNA extraction on the KingFisher™ Flex with
real-time reverse transcription polymerase chain reaction (RT-PCR) on the Applied
Biosystems™ 7500 Fast Dx
- Coming soon: Addition of approved saliva specimen for infection detection
- Targets 3 different viruses
- Targets multiple regions of the COVID-19 viral genome
- Testing Specificity: 100%
- Testing Sensitivity: >97%
- Patient Information Sheet
- Healthcare Provider Information Sheet
- Partner Information Sheet
Simple Zebra Stripe Table
Test Name |
MDL Test Code |
Sample Types |
Test Method and Description |
Price |
Additional Info. |
RSV/Influenza/COVID-19 PCR |
RIC |
Nasopharyngeal, Oropharyngeal (must be in MDL collection kit) |
This test must be collected by a healthcare professional trained in swab collection.
The MDL RIC assay is a lab developed test that utilizes a full nucleic acid extraction
followed by RT-PCR. The RT-PCR test looks for three viruses from the one sample: RSV,
Influenza (A and B not differentiated), and COVID-19. While the test only looks for
three viruses, it looks for multiple portions of each virus to increase sensitivity.
The overall test specificity is 100% and the test sensitivy is >97%. |
$97.75 |
Patient Information Sheet
Healthcare Provider Information Sheet
Collection Partner Information Sheet
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Holiday Closures
Christmas:
Wed., December 25, 2024
New Years Day:
Wed., January 1, 2025
Customer Service Support
Customer Service Hours:
Monday - Friday:
8:00 AM - 12:00 PM
1:00 PM - 5:00 PM
Phone: (316) 978-8600
Fax: (316) 978-8610
Email: mdlsupport@wichita.edu