Antigen Elisa Test Kit

Quantitative SARS COV-2 Antigen Assay Kit

(Enzyme Linked Immunoassay - ELISA)

Product characteristics

80 uL of Serum
Simple: Easy to perform, standard ELISA format
96 well format for medium throughput.
Incubator 37 C and MTP reader mandatory , MTP washer recommanded

The test is intended for medical professional and laboratory use.

Indication for Testing

To screen larger groups
To detect infection after contact with COV-2 infected persons
To validate PCR results
At onset of symptoms in addition to PCR test.

Specification

Virus Detection Limit

2 TCID50 / ml

Performance Index

LOB 1.08 pg/ml
LOD 1.66 pg/ml
LOQ 2.89 pg/ml

Linear Range

2.89 ~ 180.01 pg /ml

Precision

4.80% ~ 9.23%

No	Content	Quantity
1	Instructions for use	1 copy
2	Coated microplate	96 wells ×1 plate
3	Conjugate 1	6ml/bottle ×1 bottle
4	Conjugate 2	12ml/bottle ×1 bottle
5	Calibrators (CAL1-CAL5)	0.5ml/bottle, 5 bottles
6	Control	0.5ml/bottle×1 bottle
7	Substrate solution A	6ml/bottle ×1 bottle
8	Substrate solution B	6ml/bottle ×1 bottle
9	Stop solution ( NOT SUPPLIED )	6ml 0.5 M H2SO4
10	Concentrated washing buffer 20×	30ml/bottle ×1 bottle
11	Sealing film	3 sheets

Product Name	Sample Type	Storage Temperature	Packaging Size
Quantitative SARS COV-2 Antigen Assay Kit	Serum	Store at 2°C -8°C	96 Tests / Kit

Order Number: S-CoV2-AGET (Kit for 25 tests)
Price: From 6,50€ each test

Schematic Diagram of Antigen and Antibody Changes in Blood

Main Mechanism of Antigen into Blood

When SARS-CoV-2 invades the lung cells, it will express a large amount of self protein to reassemble the virus particles. causing cell damage and forming inﬂammation, the virus protein expressed in excess and the virus protein released from the disintegration ofvirus particles killed by the body in the lesions will enter the blood circulation through the vessel wall with increased permeability due to inﬂammation in the lesions.

Mechanism of Reduction and Elimination of Antigen in Blood

The virus antigen will stimulate the patient’s body to produce the corresponding antibody, and the antibody produced by the body will produce the specific combination with the corresponding antigen, forming the antigen antibody immune complex to be cleared by the body’s immune system. As the amount of antibody produced by the patient increases gradually, the amount of antigen cleared will also increase synchronously.
With the activation of the immune system, the ability of killing virus is enhanced, the viral load in the body will gradually decrease, and the production of virus and blood antigen will gradually decrease.

Example of Combined Test Results of Antigen and Antibody in Blood

Sample Source: PCR confirmed Covid-19 patient serum samples

Group	Days from onset	Total number of samples	Number of antigen positive samples	Sensitivity
1	≦3 day	32	30	93.4%
2	4~7 days	38	38	100%
3	8~14 days	31	28	90.3%
SUM	/	101	96	95.0%

SARS-CoV-2 Antigen Test Specificity

Cut-off value=2.89pg/mL

Sample Source: 649 population samples with negative PCR test results.

Group	Research samples	Total number of samples	Specificity
1	Infection by other respiratory pathogens	246	100%
2	Pregnancy examination	85	100%
3	Elevated rheumatoid factor	77	100%
4	Physical examination serum samples	155	100%
5	Plasma samples of inpatients in other	86	100%
SUM	/	649	100%

Positive Coincidence Rate SARS-CoV-2 Antigen and Antibody Detection (> 14 days)

Sample Source: PCR confirmed COVID-19 patients serum samples

Says from onset	Test categories	Number of positive samples	Total number of samples	Positive coicidence
> 14 days	Antigen	25	139	18.0%
> 14 days	Antibody	138	139	99.3%