Volume 26, Number 8—August 2020
Synopsis
US CDC Real-Time Reverse Transcription PCR Panel for Detection of Severe Acute Respiratory Syndrome Coronavirus 2
Table 4
Performance of the US CDC rRT-PCR panel for detection of SARS-CoV-2 with various specimen matrices spiked with SARS-CoV-2*
Virus titer, TCID50† | N1 Ct |
N2 Ct |
N3 Ct |
RP Ct |
|||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Test 1 | Test 2 | Test 3 | Call rate | Test 1 | Test 2 | Test 3 | Call rate | Test 1 | Test 2 | Test 3 | Call rate | Test 1 | Test 2 | Test 3 | Call rate | ||||
1 × 100.5 | |||||||||||||||||||
NP | 30.4 | 29.9 | 29.9 | 3/3 | 30.3 | 30.5 | 30.5 | 3/3 | 30.0 | 29.6 | 29.7 | 3/3 | 26.0 | 26.1 | 26.1 | 3/3 | |||
OP | 30.1 | 29.7 | 29.7 | 3/3 | 30.7 | 30.8 | 30.5 | 3/3 | 29.6 | 29.5 | 29.5 | 3/3 | 30.0 | 30.3 | 30.2 | 3/3 | |||
Sputum | 30.3 | 30.1 | 30.4 | 3/3 | 31.2 | 31.5 | 31.7 | 3/3 | 30.5 | 30.0 | 30.4 | 3/3 | 24.9 | 24.8 | 25.1 | 3/3 | |||
Serum | 30.1 | 29.7 | 29.8 | 3/3 | 31.1 | 31.0 | 31.1 | 3/3 | 29.8 | 29.8 | 29.6 | 3/3 | 29.1 | 28.6 | 28.3 | 3/3 | |||
Stool |
30.7 |
30.5 |
30.7 |
3/3 |
31.7 |
31.9 |
31.7 |
3/3 |
30.7 |
29.9 |
30.2 |
3/3 |
34.9 |
35.1 |
35.7 |
3/3 |
|||
1 × 100 | |||||||||||||||||||
NP | 32.1 | 30.8 | 30.4 | 3/3 | 32.3 | 32.0 | 31.6 | 3/3 | 31.3 | 30.7 | 30.9 | 3/3 | 24.5 | 24.2 | 25.0 | 3/3 | |||
OP | 31.6 | 31.3 | 31.4 | 3/3 | 32.8 | 32.3 | 32.2 | 3/3 | 30.8 | 31.3 | 31.1 | 3/3 | 29.3 | 29.2 | 29.5 | 3/3 | |||
Sputum | 32.0 | 32.0 | 31.8 | 3/3 | 33.1 | 32.9 | 32.7 | 3/3 | 31.7 | 31.4 | 32.1 | 3/3 | 24.3 | 24.3 | 24.6 | 3/3 | |||
Serum | 32.2 | 30.8 | 31.4 | 3/3 | 32.4 | 32.6 | 33.1 | 3/3 | 31.2 | 31.3 | 31.3 | 3/3 | 28.1 | 28.2 | 27.5 | 3/3 | |||
Stool |
32.1 |
32.3 |
32.0 |
3/3 |
33.6 |
33.9 |
33.5 |
3/3 |
32.1 |
32.0 |
32.1 |
3/3 |
34.6 |
35.1 |
34.5 |
3/3 |
|||
1 × 10–0.5 | |||||||||||||||||||
NP | 33.7 | 32.5 | 33.9 | 3/3 | 34.1 | 33.9 | 35.5 | 3/3 | 33.2 | 32.6 | 33.5 | 3/3 | 25.3 | 25.4 | 25.5 | 3/3 | |||
OP | 33.6 | 33.6 | 33.1 | 3/3 | 34.4 | 34.4 | 34.6 | 3/3 | 33.5 | 33.0 | 32.0 | 3/3 | 29.2 | 29.4 | 29.6 | 3/3 | |||
Sputum | 35.1 | 33.4 | 33.0 | 3/3 | 35.0 | 34.2 | 34.8 | 3/3 | 33.5 | 33.4 | 33.2 | 3/3 | 24.0 | 24.2 | 24.3 | 3/3 | |||
Serum | 33.4 | 32.2 | 33.3 | 3/3 | 35.2 | 34.1 | 33.9 | 3/3 | 32.7 | 32.7 | 33.1 | 3/3 | 28.3 | 28.2 | 29.3 | 3/3 | |||
Stool |
35.0 |
35.3 |
35.3 |
3/3 |
36.2 |
36.4 |
35.3 |
3/3 |
34.2 |
34.6 |
34.0 |
3/3 |
33.4 |
36.2 |
35.0 |
3/3 |
|||
1 × 10–1 | |||||||||||||||||||
NP | 33.9 | 34.0 | 34.6 | 3/3 | 36.0 | 36.2 | 36.5 | 3/3 | 34.1 | 34.3 | 35.1 | 3/3 | 25.6 | 25.6 | 25.9 | 3/3 | |||
OP | 33.4 | 33.3 | 33.6 | 3/3 | 35.9 | 36.7 | 35.3 | 3/3 | 34.5 | 34.3 | 35.1 | 3/3 | 29.2 | 29.3 | 29.3 | 3/3 | |||
Sputum | 35.2 | 35.0 | 36.2 | 3/3 | 36.8 | 36.8 | 35.3 | 3/3 | 35.3 | 35.2 | 35.1 | 3/3 | 24.1 | 24.1 | 24.3 | 3/3 | |||
Serum | 37.5 | 35.3 | 34.8 | 3/3 | 36.4 | 37.2 | 36.3 | 3/3 | 35.2 | 33.7 | 34.3 | 3/3 | 28.3 | 28.3 | 28.6 | 3/3 | |||
Stool |
36.1 |
35.8 |
36.0 |
3/3 |
37.3 |
37.9 |
38.1 |
3/3 |
35.8 |
35.6 |
34.7 |
3/3 |
34.1 |
33.9 |
34.2 |
3/3 |
|||
1 × 10–1.5 | |||||||||||||||||||
NP | 35.6 | 36.8 | 35.9 | 3/3 | 39.9 | 36.8 | 37.6 | 3/3 | 36.7 | 35.1 | 35.7 | 3/3 | 26.1 | 26.3 | 26.6 | 3/3 | |||
OP | 36.2 | 35.2 | Neg | 2/3 | 36.8 | 38.0 | Neg | 2/3 | Neg | Neg | Neg | 0/3 | 29.3 | 29.3 | 29.6 | 3/3 | |||
Sputum | 36.9 | 36.3 | Neg | 2/3 | 39.1 | 39.5 | 38.4 | 3/3 | 35.8 | 38.2 | Neg | 2/3 | 23.9 | 24.2 | 24.2 | 3/3 | |||
Serum | 36.8 | 36.5 | 36.4 | 3/3 | 38.4 | 39.1 | 36.9 | 3/3 | 35.6 | 36.2 | Neg | 2/3 | 27.9 | 28.2 | 27.4 | 3/3 | |||
Stool |
Neg |
Neg |
Neg |
0/3 |
39.2 |
38.1 |
37.5 |
3/3 |
35.5 |
38.1 |
38.0 |
3/3 |
34.2 |
33.3 |
35.6 |
3/3 |
|||
1 × 10–2 | |||||||||||||||||||
NP | Neg | Neg | Neg | 0/3 | 39.4 | Neg | Neg | 1/3 | Neg | Neg | Neg | 0/3 | 25.5 | 25.7 | 25.8 | 3/3 | |||
OP | Neg | Neg | Neg | 0/3 | 38.5 | 38.0 | Neg | 2/3 | 37.1 | Neg | Neg | 1/3 | 29.4 | 29.3 | 29.4 | 3/3 | |||
Sputum | 36.1 | Neg | Neg | 1/3 | 38.2 | 38.5 | Neg | 2/3 | 37.1 | 37.5 | Neg | 2/3 | 24.0 | 24.0 | 24.1 | 3/3 | |||
Serum | 37.5 | Neg | Neg | 1/3 | 39.9 | Neg | Neg | 1/3 | 38.9 | Neg | Neg | 1/3 | 28.2 | 27.9 | 27.2 | 3/3 | |||
Stool |
Neg |
Neg |
Neg |
0/3 |
39.1 |
Neg |
Neg |
1/3 |
38.1 |
Neg |
Neg |
1/3 |
33.5 |
35.1 |
34.6 |
3/3 |
|||
1 × 10–2.5 | |||||||||||||||||||
NP | 36.2 | Neg | Neg | 1/3 | 38.9 | Neg | Neg | 1/3 | Neg | Neg | Neg | 0/3 | 26.3 | 26.5 | 26.6 | 3/3 | |||
OP | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | 29.0 | 29.2 | 29.2 | 3/3 | |||
Sputum | 37.4 | Neg | Neg | 1/3 | Neg | Neg | Neg | 0/3 | 36.7 | Neg | Neg | 1/3 | 24.0 | 24.2 | 24.4 | 3/3 | |||
Serum | 36.4 | Neg | Neg | 1/3 | 38.4 | Neg | Neg | 1/3 | Neg | Neg | Neg | 0/3 | 28.1 | 28.2 | 27.2 | 3/3 | |||
Stool |
37.6 |
Neg |
Neg |
1/3 |
Neg |
Neg |
Neg |
0/3 |
Neg |
Neg |
Neg |
0/3 |
33.4 |
34.1 |
35.5 |
3/3 |
|||
1 × 10–3 | |||||||||||||||||||
NP | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | 26.8 | 26.7 | 27.0 | 3/3 | |||
OP | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | 29.2 | 29.4 | 29.1 | 3/3 | |||
Sputum | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | 23.9 | 24.1 | 24.3 | 3/3 | |||
Serum | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | 28.2 | 28.3 | 27.9 | 3/3 | |||
Stool |
Neg |
Neg |
Neg |
0/3 |
Neg |
Neg |
Neg |
0/3 |
Neg |
Neg |
Neg |
0/3 |
34.1 |
35.0 |
35.0 |
3/3 |
|||
0 | |||||||||||||||||||
NP | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | 25.0 | 25.2 | 24.8 | 3/3 | |||
OP | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | 28.6 | 28.3 | 28.5 | 3/3 | |||
Sputum | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | 23.1 | 23.0 | 23.1 | 3/3 | |||
Serum | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | 27.6 | 27.8 | 27.7 | 3/3 | |||
Stool | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | Neg | Neg | Neg | 0/3 | 33.5 | 33.8 | 33.2 | 3/3 |
*Call rate indicates each assay performed in triplicate. CDC, Centers for Disease Control and Prevention; Ct, cycle threshold; N, nucleocapsid protein gene; neg, negative; NP, nasopharyngeal; OP, oropharyngeal; 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.