Table 3.

Validation and performance evaluation of RealDetect™ Covid-19 RT-PCR kit.

		Singleplex method				Multiplex method
Result		Test by RealDetect Covid-19 RT-PCR kit	Test by xABT Multiple Real-time PCR kit	Test by RealDetect Covid-19 RT-PCR kit	Test by A* Star Fortitute kit	Test by RealDetect Covid-19 RT-PCR kit	Test by xABT Multiple Real-time PCR kit	Test by RealDetect Covid-19 RT-PCR kit	Test by A* Star Fortitute kit
Samples tested positive, N = 120	Strong (Ct ≤26) N=38	18	18	20	20	18	18	20	20
	Moderate (Ct >26 to ≤32) N = 53	27	27	26	26	27	27	26	26
	Low (Ct>32 to ≤38) N= 29	14	15	14	14	15	15	14	14
Samples tested negative, N= 120		61	60	60	60	60	60	60	60
Total sample, n		120	120	120	120	120	120	120	120
Sensitivity,% (95 % CI)		98.33 (91.06–99.96)		100 (93.98–100)		100 (93.98–100)		100 (93.98–100)
Specificity, % (95 % CI)		100 (94.04–100)		100 (93.98–100)		100 (93.98–100)		100 (93.98–100)
Positive predictive value (95 %CI)		100 (93.94–100)		100 (93.98–100)		100 (93.98–100)		100 (93.98–100)
Negative predictive value (95 %CI)		98.36 (91.2–99.96)		100 (93.98–100)		100 (93.98–100)		100 (93.98–100)
Accuracy, % (95 % CI)		99.17 (95.43–99.85)		100 (96.9–100)		100 (96.9–100)		100 (96.9–100)
Kappa value (95 % CI)		0.98 (0.8044–1.162)		1 (0.8211–1.179)		1 (0.8211–1.179)		1 (0.8211–1.179)

Abbreviations: CI, Confidence Interval.