Doc. No. GB-TCF-106-07/ Rev. No

Doc. No. GB-TCF-106-07/ Rev. No.O

Technical File

Doc. No. GB-TCF-106-07/ Rev. No.2

Technical File

1 Performance Evaluation Plan

1.1 Purpose To confirm the performance and effectiveness of GenBody Influenza/COVID-19 Ag Multi through the performance evaluation test and clinical trial designed with reference to the CLSI guideline

1.2 Responsibility - Test specialist name : Seo seul ki at the GenBody Biotech Institute - Team leader/first reviewer : Jedae Moon at the GenBody Biotech Institute.

1.3 Test guidance / regulation documents

-

diagnostic kit

- European harmonised standard EN13612:2002 and EN23640:2015,

- NCCLS (EP17-A2, EP06-A, EP07-A2, MM17-A, EP05-A3, EP12-A2, EP10-A3, EP09A2)

1.4 Information of the test diagnostic kit - Kit name : GenBody Influenza/COVID-19 Ag Multi - Catalog No. : CVIFG025 - Batch No : 3 Lots (FMFOS25201, FMFOS25202, FMFOS25203, FAFG04161, FAFG11162, FAFG18163)

1.5 Intended use GenBody Influenza/COVID-19 Ag Multi is an immunochromatographic assay kit for qualitatively and simultaneously detecting the antigens of influenza virus (type A and B) and in nasopharyngeal swab from human.

1.6 Information of instruments Confiscope G20 (Analyzer) is optional.

1.7 Information of specimen Human nasopharyngeal swab and oropharyngeal swab

Doc. No. GB-TCF-106-07/ Rev. No.O

Technical File

Doc. No. GB-TCF-106-07/ Rev. No.2

2 Analytical performance evaluation

Technical File

2.1 Analytical Sensitivity / Reference Material for SARS-CoV-2 2.1.1 Protocols

- Material: SARS-CoV-2 Iisolate: USA-WA1/2020) Culture Fluid (Heat inactivated) (Zeptomatrix corp.)

No P0 (stock) P1 P2 P3 P4 P5 P6

Serial dilution 1/1x 1/300x 1/400x 1/500x 1/600x 1/700x 1/800x

Titer 3.55.E+05 1.18.E+03 8.88.E+02 7.10.E+02 5.92.E+02 5.07.E+02 4.44.E+02

- Method: serial dilution of material spiked in matrix - No. of tests: single per sample - Test Kit: GenBody Influenza/COVID-19 Ag Multi - Protocol: followed by the manual of GenBody Influenza/COVID-19 Ag Multi - Result analysis

Sample

1

2

3

Number

of

4

repeats

5

6

7

P1 P2 P3 P4 P5 P6

Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos

Doc. No. GB-TCF-106-07/ Rev. No.O

Technical File

8 Pos Pos Pos Pos Pos Neg 9 Pos Pos Pos Pos Pos Pos 10 Pos Pos Pos Pos Pos Pos 11 Pos Pos Pos Pos Pos Pos 12 Pos Pos Pos Pos Pos Pos 13 Pos Pos Pos Pos Pos Neg 14 Pos Pos Pos Pos Pos Pos 15 Pos Pos Pos Pos Pos Pos 16 Pos Pos Pos Pos Pos Pos 17 Pos Pos Pos Pos Pos Pos 18 Pos Pos Pos Pos Pos Pos 19 Pos Pos Pos Pos Pos Pos 20 Pos Pos Pos Pos Pos Pos Pos: positive result, Neg: negative result

Sample Serial dliution

P1

1/300x

P2

1/400x

P3

1/500x

P4

1/600x

P5

1/700x

P6

1/800x

Agreement to expected result

20/20 100% 20/20 100% 20/20 100% 20/20 100% 20/20 100% 18/20 90%

Pos: positive result, Neg: negative result

Titer

1.18.E+03 8.88.E+02 7.10.E+02 5.92.E+02 5.07.E+02 4.44.E+02

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