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
23
Table 1 Efficiency of pooling based on prevalence
P, percent of positive subjects
in the tested population
n
maxefficiency
(n corresponding to the
maximal efficiency)
Efficiency (F) of n-sample
pooling
(a maximum increase in the number of
tested patients when Dorfman n-
pooling strategy used)
1% - 4%
6
4.44 -
2.60
5% - 6%
6
2.32 -
2.10
7% - 12%
6
1.92 -
1.42
13% - 25%
6
1.36 -
1.01
1% - 4%
5
4.02 -
2.60
5% - 6%
5
2.35 -
2.15
7% - 12%
5
1.98 -
1.49
13% - 25%
5
1.43 -
1.04
1% - 4%
4
3.46 -
2.50
5% - 6%
4
2.30 -
2.13
7% - 12%
4
1.99 -
1.54
13% - 25%
4
1.48 -
1.07
1% - 4%
3
2.75 -
2.23
5% - 6%
3
2.10 -
1.99
7% - 12%
3
1.89 -
1.53
13% - 25%
3
1.48 -
1.10
1% - 4%
2
1.92 -
1.73
5% - 6%
2
1.67 -
1.62
7% - 12%
2
1.57 -
1.38
13% - 25%
2
1.35 -
1.07