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
20
In Silico Sensitivity in Population with Positivity Rate 1-10% (n = 3,091)
Group
#
n
Interval
[X*, 40] for
N1
Number of
samples
with N1 Ct
values in
the interval
Interval
[X*, 40] for
N3
Number of
samples
with N3 Ct
values in
the interval
# above
both
shifted
Thresholds
Neg
Inc
Pos
% Positive Percent
Agreement*
1-3%
820
[37.0, 40]
22
[37.45, 40]
0
0
0
22
798
100% (820/820)
95% CI 99.5-100%
3-6%
1,113
[38.3, 40]
7
[38.7, 40]
0
0
0
7
1106
100% (1,113/1,113)
95% CI 99.7-100%
6-10%
1,158
[37.65, 40]
17
[38.1, 40]
0
0
0
17
1141
100% (1,158/1,158)
95% CI 99.7-100%
total
3,091
NA
46
NA
0
0
0
46
3045
100% (3,091/3,091)
95% CI 99.9-100%
* Since any pool that is not negative (i.e., positive, inconclusive, and invalid) is re-tested as individual samples, the Positive
Percent Agreement includes all pools that were not negative.
19) Omega Extraction Validation -
Limit of Detection
Remnant respiratory specimens that were previously negative for SARS-CoV-2 RNA using the Quest Diagnostics
SARS-CoV-2 Assay and the Magna Pure Method in four different types of transport media were used in the Limit of
Detection study. The four types of transport media were VCM/UTM, UTM-RT, saline (0.9% NaCl), PBS and Eswabs.
Each pool was spiked with a positive specimen and serially diluted with corresponding transport media. Ten aliquots
were extracted and amplified in duplicate. One run was repeated because the instrument malfunctioned. The Omega
extraction LOD (95% detection rate) is summarized in the table below. The previously determined LOD for the Magna
Pure Method is included for comparison.
Limit of Detection - Omega Method vs Magna Pure Method
Transport
Media
SARS-CoV-2 RNA LoD
MagnaPure Method LOD
(previously determined)
Omega LOD
≥95% Detection
(c/mL)
Probit Analysis, 95%
Detection (c/mL)
≥95% Detection
(c/mL)
Probit Analysis, 95%
Detection (c/mL)
VCM/UTM
100
100
250
184
UTM-RT
250
327
250
215
Saline
500
286
250
124
PBS
250
246
250
195
Eswab
500
368
500
394