Analytical Sensitivity for Samples with SARS-CoV-2, Flu A, and Flu B
The LOD range for SARS-CoV-2 is 125–250 viral copies/ml, for Flu A it is 1.26–2.52 TCID50/ml, and for Flu B it is 0.23 TCID50/ml on all instruments tested.
Instrument
SARS-CoV-2
Flu A**
Flu B**
CFX96 Touch
125 copies/ml
2.52 TCID50/ml
1,002 copies/ml
0.23 TCID50/ml
862 copies/ml
CFX96 Dx
250 copies/ml
2.52 TCID50/ml
1,002 copies/ml
0.23 TCID50/ml
862 copies/ml
CFX Opus 96
250 copies/ml
2.52 TCID50/ml
1,002 copies/ml
0.23 TCID50/ml
862 copies/ml
AB7500 Fast Dx
250 copies/ml
1.26 TCID50/ml
501 copies/ml
0.23 TCID50/ml
862 copies/ml
LOD units
Copies/ml — number of copies of viral RNA detected per milliliter of sample.
TCID50/ml — represents the “Median Tissue Culture Infectious Dose” per milliliter of sample, and is used to verify viral titer. TCID50 signifies the concentration at which 50% of the cells are infected when the sample is inoculated with a diluted solution of viral fluid.
*The Qiagen Viral RNA Mini Kit was the nucleic acid purification method used. ** Live cultured virus
Clinical Evaluation for Samples Containing SARS-CoV-2, Flu A, and Flu B
The performance of the Bio-Rad Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Assay Kit was evaluated with clinical nasopharyngeal swab samples using 32 individual negative clinical samples, 41 confirmed SARS-CoV-2 positive clinical samples, 69 confirmed Influenza B positive clinical samples, and 69 confirmed Influenza A positive clinical samples. Clinical study results show a 100% percent positive agreement (PPA) and a 100% negative percent agreement (NPA) with a 95% confidence interval.
SARS-CoV-2 Samples Processed with the Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Kit
RT-PCR Kit
Comparator #1 and #2 Positive
Comparator #1 and #2 Negative
Total
PPA [95% CI]
NPA [95% CI]
Test positive
41
0
41
97.6% [87.7–99.6%]
100%
Inconclusive
0
0
0
Test negative
1*
0
1
Total
42
0
42
Influenza A Samples Processed with the Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Kit
RT-PCR Kit
Comparator #3 and #4 Positive
Comparator #3 and #4 Negative
Total
PPA [95% CI]
NPA [95% CI]
Test positive
69
0
69
100% [94.7–100%]
100%
Inconclusive
0
0
0
Test negative
0
0
0
Total
69
0
69
Influenza B Samples Processed with the Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Kit
RT-PCR Kit
Comparator #4 Positive
Comparator #4 Negative
Total
PPA [95% CI]
NPA [95% CI]
Test positive
43
0
43
100% [91.8–100%]
100%
Inconclusive
0
0
0
Test negative
0
0
0
Total
43
0
43
Negative Samples Processed with the Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Kit
RT-PCR Kit
Comparator #4 Positive
Comparator #4 Negative
Total
PPA [95% CI]
NPA [95% CI]
Test positive
0
0
32
100% [89.3–100%]
100%
Inconclusive
0
0
0
Test negative
32
0
1
Total
32
0
32
Clinical evaluations. Testing of samples containing SARS-CoV-2, Influenza A, or Influenza B and negative samples in a 2 x 2 comparison of the comparator tests with the Bio-Rad Reliance SARS-CoV-2, Flu A, and Flu B RT-PCR Assay Kit.
*The discordant sample was adjudicated using the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (EUA), which confirmed the negative results for SARS-CoV-2.
SARS-CoV-2, Flu A, and Flu B Assay Data Examination and Interpretation
Results are for the identification and differentiation of SARS-CoV-2 RNA from Influenza A RNA and Influenza B RNA. These viruses are generally detectable in upper respiratory specimens during the acute phase of their infection.
Positive results are indicative of the presence of the respiratory virus(es) indicated
Negative results do not preclude infection with respiratory virus(es) and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information
SARS-CoV-2 N1 Result
Flu A M1 Result
Flu B NS2 Result
Internal Control RP Result
Interpretation
Positive (Cq<40)
Negative (Cq≥40 or N/A)
Negative (Cq≥40 or N/A)
Positive or Negative
SARS-CoV-2 detected
Negative (Cq≥40 or N/A)
Positive (Cq<40)
Negative (Cq≥40 or N/A)
Positive or Negative
Influenza A detected
Negative (Cq≥40 or N/A)
Negative (Cq≥40 or N/A)
Positive (Cq<40)
Positive or Negative
Influenza B detected
Negative (Cq≥40 or N/A)
Positive (Cq<40)
Positive (Cq<40)
Positive or Negative
Influenza A and Influenza B detected
Positive (Cq<40)
Positive (Cq<40)
Negative (Cq≥40 or N/A)
Positive or Negative
Influenza A and SARS-CoV-2 detected
Positive (Cq<40)
Positive (Cq<40)
Positive (Cq<40)
Positive or Negative
Influenza A and Influenza B and SARS-CoV-2 detected
Positive (Cq<40)
Negative (Cq≥40 or N/A)
Positive (Cq<40)
Positive or Negative
Influenza B and SARS-CoV-2 detected
Negative (Cq≥40 or N/A)
Negative (Cq≥40 or N/A)
Negative Cq≥40 or N/A)
Positive (Cq<40)
Virus not detected; consider testing for other respiratory viruses
Negative (Cq≥40 or N/A)
Negative (Cq≥40 or N/A)
Negative (Cq≥40 or N/A)
Negative (Cq≥40 or N/A)
Invalid Result
Real-time PCR detection of multiple RNA targets from the SARS-CoV-2 virus as well as the Influenza A and Influenza B viruses with high sensitivity and speed.
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