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
21
20) Omega Extraction Validation - Agreement with the MagnaPure Extraction Method (n = 168)
Quest selected randomly 168 specimens that had been previously tested for SARS-CoV-2 RNA using the Quest
Diagnostics SARS-CoV-2 Assay and the Magna Pure Method. Of the 168 specimens selected 78 were positive
previously and 90 were negative previously. Specimens included a range of transport media types (VCM/UTM, UTM-
RT, PBS, Saline (0.9% NaCl) and Eswabs), and Ct values. Results using the Omega method were compared to the
previous results using the Magna Pure Method and percent agreement was calculated. The agreement was 98.7%
(77/78, 95%CI 93.1-100%) with positive specimens, and 93.3% (84/90, 95%CI 86.0-97.5%) with negative specimens.
Agreement with the Magna Pure Extraction Method (n = 168)
Magna Pure
Method
n
Omega Method
% Agreement
Negative
Inconclusive
Positive
Invalid
Positive
78
1
0
77
0
98.7% (77/78)
95%CI 93.1-100%
Negative
90
84
0
6*
0
93.3% (84/90)
95%CI 86.0-97.5%
* Quest Diagnostics performed an ad hoc discrepant analysis after the study and determined that 6/6
discordant specimens were low positives with the Omega extraction method.
21) Removal of RNase P Control for Unobserved Self-Collection – RNase P Negative Rate in Health Program Population (n =
37,084)
Quest Diagnostics selected all specimens (n = 37,084) that were self-collected without observation under a health
program sponsored by an employer or school of higher education. All specimens were tested with the Quest SARS-
CoV-2 rRT-PCR and RNase P RT-PCR. Of the 37,084 specimens, 12,303 were from females and 24,781 were
males. Of the 12,303 females, 100% (12,302/12,303 95% CI 100-100%) had an acceptable Ct value for the RNase
P marker, and 0.008% (1/12,303) had an unacceptable Ct value (>35) for the RNase P marker. Of the 24,781 males,
100% (24,776/24,781, 95% CI 100-100%) had an acceptable Ct value for the RNase P marker and 0.020%
(5/24,781) had an unacceptable Ct value (>35) for the RNase P marker. These data demonstrate that nearly all
participants were able to self-collect an adequate nasal swab specimen for SARS-CoV-2 testing.
References
Contact Information, Laboratory Service Ordering, and Support
Quest Diagnostics Infectious Disease, Inc.
33608 Ortega Highway, Bldg. B-West Wing
San Juan Capistrano, CA 92675
U.S.A.
+1.949.728.4000
QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered
or unregistered trademarks are the property of Quest Diagnostics. All third-party marks—® and ™—are the property of
their respective owners. ©2020 Quest Diagnostics Incorporated. All rights reserved. SBW1218 rev 11/12/2020