Evaluation of the MAScIR SARS-CoV-2 M Kit 2.0 on the SARS-CoV-2 Infection

Table 1

Repeatability and intermediate precision tests results of MAScIR SARS-CoV-2 kit M 2.0.

	Target	Number of values (N)	Mean of Ct	SD	CV%	CV%	Conclusion
						Supplier notice
Repeatability
Concentration of samples
High concentration	RdRp	5	14.52	0.39	2.69	1.56	Compliant
	S		16.02	0.87	5.44	1.22	Limit
	CI		21.94	0.33	1.49	1.69	Compliant
Medium concentration	RdRp	5	27.61	0.63	2.29	1.70	Compliant
	S		28.69	0.50	1.76	1.86	Compliant
	CI		25.15	0.45	1.77	2.48	Compliant
Low concentration	RdRp	5	33.24	0.73	2.20	1.70	Compliant
	S		34.63	1.06	3.06	1.86	Compliant
	CI		24.19	0.90	3.73	2.48	Compliant
Intermediate precision
Thermal cycler
QS5	RdRp	26	19.56	1.11	5.67	2.54	Compliant
	S		20.64	1.09	5.27	1.87	Compliant
	CI		21.95	1.18	5.39	3.49	Compliant
Exicycler	RdRp	13	21.62	0.75	3.46	2.54	Compliant
	S		21.04	0.87	4.11	1.87	Compliant
	CI		21.05	0.98	4.67	3.49	Compliant
Global intermediate precision (QS5 + Exicycler)	RdRp	39	20.25	1.40	6.90	2.54	Limit
	S		20.78	1.03	4.93	1.87	Compliant
	CI		21.65	1.19	5.49	3.49	Compliant

CV, coefficient of variation; SD, standard deviation.