Table 2. Limit of detection test results of three commercial kits for the multiplex PCR detection of SARS-CoV-2 and influenza virus A/B detection with reference material (AccuPlex™ SARS-CoV-2 reference material kit).
| Target genes | No. detected/No. replicates at each concentration (copies/mL) | LoD in copies/mL (95% CI) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 5,000 | 1,667 | 500 | 167 | 50 | 17 | 5 | |||
| PowerChek | |||||||||
| SARS-CoV-2 E gene | 8/8 | 8/8 | 24/24 | 23/24 | 12/24 | 8/24 | 1/24 | 212.1 (126.7–507.5) | |
| SARS-CoV-2 ORF1ab gene | 8/8 | 8/8 | 24/24 | 13/24 | 2/24 | 0/24 | 0/24 | 402.3 (279.6–799.1) | |
| Influenza virus A M gene | 8/8 | 8/8 | 18/24 | 7/24 | 1/24 | 5/24 | 2/24 | 5,661.8 (875.7–62,746,173) | |
| Influenza virus B NP gene | 8/8 | 8/8 | 24/24 | 24/24 | 21/24 | 8/24 | 3/24 | 88.8 (55.8–203.0) | |
| STANDARD M | |||||||||
| SARS-CoV-2 E gene | 8/8 | 8/8 | 20/24 | 17/24 | 10/24 | 2/24 | 2/24 | 1,176.4 (571.2–3,932.9) | |
| SARS-CoV-2 ORF1ab gene | 8/8 | 8/8 | 24/24 | 21/24 | 18/24 | 4/24 | 4/24 | 259.7 (145.7–680.7) | |
| Influenza virus A M gene | 8/8 | 6/8 | 11/24 | 3/24 | 2/24 | 0/24 | 1/24 | 11,205 (1,744.8–624,142,878) | |
| Influenza virus B NS1 gene | 8/8 | 8/8 | 22/24 | 19/24 | 10/24 | 2/24 | 1/24 | 578.0 (325.5–1,470.9) | |
| Allplex | |||||||||
| SARS-CoV-2 N gene | 8/8 | 8/8 | 19/24 | 10/24 | 4/24 | 2/24 | 0/24 | 1,649.6 (838.4–5,316.7) | |
| SARS-CoV-2 RdRp gene | 8/8 | 8/8 | 24/24 | 21/24 | 14/24 | 5/24 | 2/24 | 283.5 (163.9–702.2) | |
| SARS-CoV-2 S gene | 8/8 | 8/8 | 24/24 | 20/24 | 14/24 | 7/24 | 3/24 | 361.0 (193.9–1,027.8) | |
| Influenza virus A M gene | 8/8 | 8/8 | 10/24 | 7/24 | 2/24 | 1/24 | 0/24 | 4,917.3 (2,070.1–24,922) | |
| Influenza virus B NS gene | 8/8 | 8/8 | 24/24 | 23/24 | 11/24 | 5/24 | 2/24 | 248.9 (147.1–596.1) | |
| RSV M gene | 8/8 | 8/8 | 24/24 | 23/24 | 12/24 | 3/24 | 4/24 | 282.48 (160.43–718.78) | |
PCR = polymerase chain reaction, SARS-CoV-2 = severe acute respiratory syndrome-coronavirus-2, LoD = limit of detection, CI = confidence interval, RSV = respiratory syncytial virus.