| COVID-19-N Protein

The novel coronavirus is an infectious disease caused by the virus SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). The first known case was identified in Wuhan, China, in December 2019. The disease rapidly spread worldwide, leading to the COVID-19 pandemic. Its symptoms are variable but typically include fever, cough, headache, fatigue, shortness of breath, loss of smell, and loss of taste. Symptoms may begin one to fourteen days after exposure to the virus. At least one-third of infected individuals do not develop noticeable symptoms.
 

| Typical data

As the OD values of the standard curve may vary according to the conditions of the actual assay performance (e.g. operator, pipetting technique, wash technique or temperature effects), the operator should establish a standard curve for each test. Typical standard curve and data are provided below for reference only.

 

Concentration (ng/mL)	10	5	2.5	1.25	0.62	0.31	0.15	0
OD	2.7	2.05	1.31	0.77	0.49	0.3	0.21	0.1
Corrected OD	2.6	1.95	1.21	0.67	0.39	0.2	0.11	-

 

| Repeatability

Intra-assay Precision (Precision within an assay)：CV% < 10%; Inter-assay Precision (Precision between assays)：CV% < 10%
 

| Recovery

The recovery of Human COVID-19-N Protein spiked at three different levels in samples throughout the range of the assay was evaluated in various matrices.

 

Sample Type	Range(%)	Average Recovery(%)
Serum(n=8)	84-105	96
Plasma(n=8)	92-105	102
Cell Culture Supernates(n=8)	96-110	107

 

| Linearity

Samples were spiked with high concentrations of Human COVID-19-N Protein and diluted with Universal Diluent to produce samples with values within the range of the assay.

 

		Serum(n=4)	Plasma(n=4)	Cell Culture Supernates(n=4)
1 : 2	Range (%)	82-99	88-97	90-110
	Average (%)	91	92	97
1 : 4	Range (%)	89-104	87-110	105-115
	Average (%)	94	98	109