Evaluation of Analytical Performance of Seven Rapid Antigen Detection Kits for Detection of SARS-CoV-2 Virus

Figures & data

Figure 1 Outline of study methodology. Swab was collected in universal transport medium. RT-PCR was done to identify targeted SARS-CoV-2 specific genes. The viral nucleocapsid protein were extracted and applied to a rapid antigen test device.

Table 1 Comparison of Results of Seven Rapid Antigen Testing Kits with RT-PCR Positive Samples

Sample ID	PCR Ct Average	Antigen Kit #1	Antigen Kit #2	Antigen Kit #3	Antigen Kit #4	Antigen Kit #5	Antigen Kit #6	Antigen Kit #7
Specimen#1	15–19	Negative	Negative	Negative	Negative	Negative	Positive	Negative
Specimen#2	22–25	Negative	Negative	Negative	Negative	Negative	Negative	Negative
Specimen#3	27–30	Negative	Negative	Negative	Negative	Negative	Negative	Negative
Specimen#4	31–33	Negative	Negative	Negative	Negative	Negative	Negative	Negative
Specimen#5	34–36	Negative	Negative	Negative	Negative	Negative	Negative	Negative

Table 2 Determination of Viral Load from RT-PCR Ct Value

RNA NAAT Detectable Unit/mL	Hit Rate	Replicate 1 Ct Value	Replicate 2 Ct Value	Replicate 3 Ct Value
1.8x10^7	3/3	25.13	24.89	25.01
1.8x10^6	3/3	26.98	29.37	29.38
1.8x10^5	3/3	32.74	33.01	32.65
1.8x10^4	3/3	35.87	35.91	36.23
1.8x10^3	2/3	39.82	33.85	Neg
1.8x10^2	0/3	Neg	Neg	Neg

Table 3 Comparison of Results of Seven Rapid Antigen Testing Kits with Various Concentrations of Heat-Inactivated SARS-CoV-2

Viral Content	Viral Particle/Reaction (Approx.)	Antigen Kit #1	Antigen Kit #2	Antigen Kit #3	Antigen Kit #4	Antigen Kit #5	Antigen Kit #6	Antigen Kit #6
7.5x10^5/mL	60,000/80 µL	Negative	Negative	Negative	Negative	Negative	Negative	Negative
3.75x10^5/mL	30,00/80 µL	Negative	Negative	Negative	Negative	Negative	Negative	Negative
1.85x10^5/mL	15,000/80 µL	Negative	Negative	Negative	Negative	Negative	Negative	Negative
9.5x10^4/mL	7,500/80 µL	Negative	Negative	Negative	Negative	Negative	Negative	Negative
4.6x10^4/mL	3,750/80 µL	Negative	Negative	Negative	Negative	Negative	Negative	Negative