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For Validation and Monitoring of COVID-19 Molecular Diagnostic Methods
Levels
Low Positive Level / Limit of Detection Level
Product Dating
SLI Medical Acceptable Dating: we will ship >= 90 days
Test Name
Coronavirus 2019 (COVID-19)
UNSPSC Code
41116145
Volume
20 µl Fill
Features
The AcroMetrix™ Coronavirus 2019 (COVID-19) RNA Control is NOT a control for antibody testing
Kit contains two controls: Low Positive: approx 5000 cp/mL; also LOD control: approx 1
000 cp/ml - both are recommended by FDA on each plate to demonstrate that low end is captured/mitigate false negatives
Non-infectious
RNA transcripts
not whole genome; N
S
E
and Orf1ab
In-process control; use post extraction; for full-process
recommend similar RNA virus with same extraction protocol and matrix ie. HIV
Shipped and stored at -20°C
upon opening vial is stable at 2° - 8°C for 7 days
3 freeze/thaws allowed
2 vials per kit
20uL fill
1 vial per control
Will work with any assay or LDT
RUO as recommended by FDA