Instruction Manual
Table Of Contents
- Intended Use
- Summary and Explanation
- Principles of the Procedure
- Materials Required (Provided)
- DTT solution 500mM
- SARS-CoV-2 PCR Mix
- Equipment and Supplies
- Warnings and Precautions
- Specimen Collection, Handling, and Storage
- Procedure
- For viscous samples (sputum and bronchial wash): Performed inside BSC 2
- NOTE: In the event that the test system becomes inoperable, notify supervision or designee for further direction. Patient specimens must be stored in a manner that maintains the integrity of the specimen.
- Quality Control
- Limitations
- Conditions of Authorization for the Laboratory
- Performance Characteristics
- References
12
Analyzing the Run Data, Exporting Results and Printing
2.
Click on “Analysis”, and then click on “Analysis Settings”.
For 2019-NCOV PCR MIX
Manual Ct should be selected
Set the threshold at 0.1 for NCOV1, automatic baseline
Set the threshold at 0.01 for NCOV3, automatic baseline
Set the threshold at 0.05 for IPC, automatic baseline
3.
Click the Analyze icon () from the toolbar.
Note: Wait approximately one minute for the analysis process to be completed.
4.
Click the Results Tab.
5.
Click the Amplification Plot tab.
6.
Choose NCOV1, NCOV3, and IPC from the Detector window.
7. Click one well containing a specimen at a time and look at the Amplification plot and Component plot to check for
the accuracy of the result.
8.
Choose Save option from the File menu after analyzing all the wells.
9. To export the results to the LIS, start by highlighting the wells containing NCOV1, NCOV3, and IPC reactions from
the plate grid.
10.
From the File menu, choose Export and then Results.
11.
Select “Taqman on ‘samba (\\lis.focusdx.priv)’ M in the Look in window.
12.
Type in the name of the plate in the File Name window (e.g.: QINF 031918 EXPORT).
Note: Make sure to export the files as Text file (Tab-delimited file) and include the word “EXPORT” in the file name
to help distinguish exported file from imported file.
13.
Click the Save button.
Note: It will take approximately 15 minutes for LIS to download the results. Do not open the exported file while it is
being transferred.
14.
To print the results, choose Print from the File menu.
15.
Click Print and then click O.K.
NOTE: In the event that the test system becomes inoperable, notify supervision or designee for further
direction. Patient specimens must be stored in a manner that maintains the integrity of the specimen.