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
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2019-nCoV_N1 Probe
2019-nCoV_N3 Forward Primer
2019-nCoV_N3 Reverse Primer
2019-nCoV_N3 Probe
Reagent Preparation and Storage
Primer and Probe 10µM stocks in TE Buffer
Dilute Probes 100 µM stocks 1:10 in TE Buffer ex: 100 µL + 900 µL TE Buffer). Prepare aliquots in screw cap tubes.
Dilute Primers 200 µM stocks 1:10 in TE Buffer ex: 50 µL + 950 µL TE Buffer). Prepare aliquots in screw cap tubes.
Storage Store @ -60ºC to -90ºC
Stability 1 year from date of preparation.
Formulation sheet EFORM.129. 01480
4x RT-PCR enzyme mix 1 mL aliquots
Thaw / equilibrate 10mL bottle(s) of 4x RT-PCR enzyme mix to room temperature (protect from light). Mix bottle contents
thoroughly by inversion and gentle swirling. Transfer 1.0 mL aliquots of mix to pre-labeled sterile screw cap tubes.
Storage Store @ -60ºC to -30ºC
Stability as specified by manufacturer on bottle
5 mg/mL poly (A)
Dissolve 100 mg of poly (A) in 20 mL of DEPC-water in a 50 mL sterile centrifuge tube. Vortex until completely
dissolved. Prepare 1 mL aliquots in screw cap tubes.
Storage Store @ -60ºC to -90ºC
Stability 2 years from date of preparation.
RNA Diluent P
Add 1 mL of 5 mg/mL poly (A) to 1 x 500 mL bottle of 1x PBS (new, unopened, without CA, Mg salts). Mix well. Prepare
40 mL aliquots in 50 mL sterile centrifuge tubes. The final concentration of poly (A) is 10 µg/mL.
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In the event that a RNA internal process control is temporarily unavailable, a DNA internal process control, exhibiting
similar PCR performance, may be used temporarily.