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Volume 26, Number 8—August 2020
Synopsis

US CDC Real-Time Reverse Transcription PCR Panel for Detection of Severe Acute Respiratory Syndrome Coronavirus 2

Xiaoyan Lu, Lijuan Wang, Senthilkumar K. Sakthivel, Brett Whitaker, Janna Murray, Shifaq Kamili, Brian Lynch, Lakshmi Malapati, Stephen A. Burke, Jennifer Harcourt, Azaibi Tamin, Natalie J. Thornburg, Julie M. Villanueva, and Stephen LindstromComments to Author 
Author affiliations: Centers for Disease Control and Prevention, Atlanta, Georgia, USA (X. Lu, B. Whitaker, S.A. Burke, J. Harcourt, A. Tamin, N.J. Thornburg, J.M. Villanueva, S. Lindstrom); Synergy America, Inc., Atlanta (L. Wang, S. Kamili); Eagle Contracting, Atlanta (S.K. Sakthivel, J. Murray, B. Lynch); Leidos, Atlanta (L. Malapati); Battelle, Atlanta (S.A. Burke)

Main Article

Table 5

Reproducibility of the US CDC rRT-PCR panel for detection of SARS-CoV-2 with respiratory specimen matrix spiked with SARS-CoV-2*

Virus titer, TCID50 N1 Ct
N2 Ct
N3 Ct
RP Ct
Test 1 Test 2 Test 3 Test 1 Test 2 Test 3 Test 1 Test 2 Test 3 Test 1 Test 2 Test 3
Day 1
1.0 × 103 21.1 21.1 21.0 21.5 21.2 21.5 21.0 21.1 21.1 26.0 25.9 26.1
1.0 × 101 27.8 27.6 27.5 28.6 28.6 28.9 27.6 27.3 27.7 26.0 25.8 26.1
1.0 × 10−1
35.6
33.8
33.8

34.7
34.2
34.5

34.0
34.5
33.7

26.4
26.4
26.4
Day 2
1.0 × 103 21.8 21.8 21.8 21.6 21.5 21.6 21.2 21.1 21.2 26.5 26.3 26.3
1.0 × 101 28.4 28.3 28.5 29.4 29.3 29.0 28.1 28.0 28.1 26.7 26.7 26.67
1.0 × 10−1
37.6
35.7
34.0

36.0
34.7
34.9

34.1
33.8
34.5

26.8
26.3
26.2
Day 3
1.0 × 103 20.8 20.7 20.8 20.6 20.4 20.6 20.7 20.6 20.7 26.8 26.7 26.9
1.0 × 101 27.1 27.6 27.3 27.5 27.6 27.4 27.2 27.3 27.3 26.6 26.8 26.8
1.0 × 10−1
34.2
33.9
34.1

33.1
33.5
34.9

33.2
34.2
33.5

26.6
26.9
26.7
Summary results Mean SD CV Mean SD CV Mean SD CV Mean SD CV
1.0 × 103 21.2 0.5 2.2% 21.2 0.5 2.3% 21.0 0.2 1.1% 26.4 0.4 1.4%
1.0 × 101 27.8 0.5 1.8% 28.5 0.8 2.8% 27.6 0.4 1.3% 26.5 0.4 1.5%
1.0 × 10−1 34.7 1.3 3.7% 34.5 0.8 2.5% 33.9 0.4 1.2% 26.5 0.2 0.9%

*Specimen matrix constructed from combined nasopharyngeal swabs obtained from 10 persons. CDC, Centers for Disease Control and Prevention; Ct, cycle threshold; neg, negative; CV, coefficient of variation; N, nucleocapsid protein gene; RP, ribonuclease P gene; rRT-PCR, real-time reverse transcription PCR; SARS-CoV-2, severe acute respiratory coronavirus 2; TCID50, 50% tissue culture infectious dose.
†50% tissue culture infectious dose/mL.

Main Article

Page created: May 14, 2020
Page updated: July 17, 2020
Page reviewed: July 17, 2020
The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above.
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