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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
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2 Analytical performance evaluation
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 Serial dilution Titer
P0 (stock) 1/1x 3.55.E+05
P1 1/300x 1.18.E+03
P2 1/400x 8.88.E+02
P3 1/500x 7.10.E+02
P4 1/600x 5.92.E+02
P5 1/700x 5.07.E+02
P6 1/800x 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 P1 P2 P3 P4 P5 P6
Number
of
repeats
1 Pos Pos Pos Pos Pos Pos
2 Pos Pos Pos Pos Pos Pos
3 Pos Pos Pos Pos Pos Pos
4 Pos Pos Pos Pos Pos Pos
5 Pos Pos Pos Pos Pos Pos
6 Pos Pos Pos Pos Pos Pos
7 Pos Pos Pos Pos Pos Pos
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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 Agreement to
expected result Titer
P1 1/300x 20/20 100% 1.18.E+03
P2 1/400x 20/20 100% 8.88.E+02
P3 1/500x 20/20 100% 7.10.E+02
P4 1/600x 20/20 100% 5.92.E+02
P5 1/700x 20/20 100% 5.07.E+02
P6 1/800x 18/20 90% 4.44.E+02
Pos: positive result, Neg: negative result
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2.1.2 Conclusion
- As shown in the result tables, GenBody COVID-19 Ag concentration was detected
1/3200x and it is 3.59x 103 TCID50/ml
2.2 Anlytical Sensitivity / Reference Material for influenza A/B Ag
- Material: See under below;
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- Method: Each Instructions for Use and serial dilution
- Test Kit: GenBody Influenza A/B Ag(Lot No.: FAFG04161)
- Protocol: Follow GenBody Influenza A/B Ag IFU and each product IFU
- Test guidance : Evaluation of Detection Capability for Clinical Laboratory Measurement
Procedure; Approved Guideline, EP17-A2, NCCLS
- Results
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- *ELISA analysis
- -sample value : >1.1 : positive, <0.9 : negative
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- -sample value: >1.1 : positive, <0.9 : negative
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- -sample value : >1.1 : positive, <0.9 : negative
2.3 Analytical Sensitivity / LoD for SARS-CoV-2
2.3.1 Protocols
- Material: SARS-CoV-2 Iisolate: USA-WA1/2020) Culture Fluid (Heat inactivated)
(Zeptomatrix corp.)
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- Method: serial dilution of material spiked in matrix
- No. of tests: 20 times 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 P12 P13 P14 P15 P16 P17
Number
of
repeats
1 Pos Pos Pos Pos Pos Neg
2 Pos Pos Pos Pos Pos Neg
3 Pos Pos Pos Pos Pos Neg
4 Pos Pos Pos Pos Pos Neg
5 Pos Pos Pos Pos Pos Neg
6 Pos Pos Pos Pos Pos Neg
7 Pos Pos Pos Pos Pos Neg
8 Pos Pos Pos Pos Pos Neg
9 Pos Pos Pos Pos Pos Neg
10 Pos Pos Pos Pos Pos Neg
11 Pos Pos Pos Pos Pos Neg
12 Pos Pos Pos Pos Pos Neg
13 Pos Pos Pos Pos Pos Neg
14 Pos Pos Pos Pos Pos Neg
15 Pos Pos Pos Pos Pos Neg
16 Pos Pos Pos Pos Pos Neg
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17 Pos Pos Pos Pos Pos Neg
18 Pos Pos Pos Pos Pos Neg
19 Pos Pos Pos Pos Pos Neg
20 Pos Pos Pos Pos Pos Neg
Pos: positivie result, Neg: negative result
P5 20/20 100%
P6 0/20 0%
2.3.2 Conclusion
- As shown in the result tables, GenBody COVID- is
2.87x 103 TCID50/ml
2.4 Analytical Sensitivity / Limit of Detection for influenza A/B Ag
- Metarial: See under below;
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- Method: each IFU
- Test Kit: GenBody Influenza A/B Ag (Lot No.: FAFG04161)
- Protocol: Follow GenBody Influenza A/B Ag Instruction for use and each product IFU
- Test guidance : Evaluation of Detection Capability for Clinical Laboratory Measurement
Procedure; Approved Guideline, EP17-A2, NCCLS
- Result analysis
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11) Influenza Antigen B/Victoria/2/87(B/Beijing/1/87 -Like) LoD
2.4.1.1 Comparison RDT for influenza A/B Ag
- Material
- Method: Spiked Reference Material in negative sample.
- Protocol: Follow GenBody Influenza A/B Ag manual and each product IFU
- Test guidance : Evaluation of Detection Capability for Clinical Laboratory Measurement
Procedure; Approved Guideline, EP17-A2, NCCLS
- Result analysis
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4) Negative
3. Analytical Specificity
3.1. Analytical Specificity (Interfering substances testing) for SARS-CoV-2
3.1.1. Protocols -
Material:
Sort Product name Concentration Titer
Positive
material
SARS-CoV-2 isolate:
USA-WA1/2020) Culture
Fluid (Heat inactivated),
#0810587CFHI
Low (2.5x
LoD)
7.18*103
TCID50/ml
Negative
material Extraction solution N/A N/A
- Method: Material spiked in matrix
- No. of tests: triplecate gle per sample
- Test Kit: GenBody Influenza/COVID-19 Ag Multi (Lot No.: FMFOS25201)
- Protocol: followed by the manual of GenBody Influenza/COVID-19 Ag Multi
- Test guidance : Interference Testing in Clinical Chemistry ; Approved GuidelineSecond
Edition, EP07-A2, NCCLS
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Interfering Substance Concentration
(mg/dL)
+SARSCoV-
2
-SARS-CoV-
2
Viral Transport Medium
(VTM) 50% + + + - - -
Whole blood 5% + + + - - -
NasoGEL (NeilMed) 5% v/v + + + - - -
Phenylephrine (Nasal
Drop) 10% v/v + + + - - -
Acetylsalicylic acid 20 mg/ml + + + - - -
Beclomethasone 0.5 mg/ml + + + - - -
Benzocaine (Vicks) 5% + + + - - -
Flunisolide 3 mg/ml + + + - - -
Guaiacol glyceryl ether 20 mg/ml + + + - - -
Menthol 10 mg/ ml + + + - - -
Oxymetazoline (Afrin) 15% v/v + + + - - -
Tobramycin 40 mg/ml + + + - - -
Zanamivir 3.3 mg/ml + + + - - -
Oseltamivir phosphate
(Tamiflu) 12 mg/mL + + + - - -
Cromolyn (Nasal Spray) 40 mg/ ml + + + - - -
Homeopathic (Alkalol) 5% v/v + + + - - -
Zicam Cold Remedy 5% v/v + + + - - -
mucous 35% + + + - - -
+: Positive signal -: Negative signal
3.1.3. Conclusion
No positive, smearing and/or negative interference due to each material test was not
observed.
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3.2. Analytical Specificity(Interfering substances testing) for influenza A/B Ag
3.2.1. Protocols
- No. of tests: Triplicate per sample
- Test Kit: GenBody Influenza A/B Ag (Lot No.: FAFG04161, FAFC13184)
- Protocol: Follow GenBody Influenza A/B Ag manual
- Test guidance : Interference Testing in Clinical Chemistry ; Approved Guideline-Second Edition,
EP07-A2, NCCLS
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3.2.2. Results
Microorganism Concentration
+SARSCoV-
2
-
SARSCoV-
2
Adenovirus (e.g. C1 Ad. 71) -
Type 7A
1.41 x 105
TCID50/mL + + + - - -
Enterovirus (e.g. EV68) 5.01 x 105
TCID50/mL + + + - - -
Human Metapneumovirus
(hMPV)
3.80 x 106
TCID50/mL + + + - - -
Influenza A H1N1 (New Cal/20/99) 1.15 x 107
TCID50/mL + + + - - -
Influenza B (Florida/02/06) 1.41 x 105
TCID50/mL + + + - - -
Parainfluenza virus 1 9.12 x 108
TCID50/mL + + + - - -
Parainfluenza virus 2 4.17 x 105
TCID50/mL + + + - - -
Parainfluenza virus 3 6.61 x 106
TCID50/mL + + + - - -
Parainfluenza virus 4A 1 x 106.58 TCID50/mL
+ + + - - -
Respiratory syncytial virus -Type A 3.80 x 106
TCID50/mL + + + - - -
Rhinovirus (Type 1A) 1 x 106.58 TCID50/mL
+ + + - - -
Bordetella pertussis 1.13 x 1010 CFU/mL
+ + + - - -
Candida albicans 6.27 x 108 CFU/mL
+ + + - - -
Chlamydia pneumoniae 2.12 x 108
IFU/mL + + + - - -
Haemophilus influenzae 5.43 x 108 CFU/mL
+ + + - - -
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Legionella pneumophila 1.63 x 1010 CFU/mL
+ + + - - -
Mycobacterium tuberculosis 6.86 x 107 CFU/mL
+ + + - - -
Mycoplasma pneumoniae 3.16 x 108 CCU/mL
+ + + - - -
Pneumocystis jirovecii (PJP) -S.
cerevisiae Recombinant
3.45 x 108 CFU/mL + + + - - -
Pseudomonas aeruginosa 3.44 x 109 CFU/mL
+ + + - - -
Staphylococcus epidermis 9.27 x 109 CFU/mL
+ + + - - -
Streptococcus pneumoniae 4.16 x 108 CFU/mL
+ + + - - -
Streptococcus pyogenes 1.64 x 109 CFU/mL
+ + + - - -
Streptococcus salivarius 8.17 x 108 CFU/mL
+ + + - - -
MERS-coronavirus 3.55 x 105
TCID50/mL + + + - - -
Human coronavirus 229E 4.17 x 105
TCID50/mL + + + - - -
Human coronavirus OC43 1.26 x 106
TCID50/mL + + + - - -
Human coronavirus NL63 1.41 x 105
TCID50/mL + + + - - -
SARS-coronavirus (in PBS) 1 x 108
PFU/mL + + + - - -
SARS-coronavirus
(Vero E6 Cell DMEM)
1 x 108
PFU/mL + + + - - -
Pooled human nasal wash 100% + + + - - -
Human coronavirus HKU1 N/A Not Tested Not Tested
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3.3. Cross-reactivity for SARS-CoV-2
3.3.1. Protocols
- Material:
- No. of tests: Triplecate per sample
- Test Kit: GenBody Influenza/COVID-19 Ag Multi
- Protocol: followed by the manual of GenBody Influenza/COVID-19 Ag Multi
- Test result: There was cross-reactivity of SARS-coronavirus and no cross reactivity was
observed for any of virus and bacterium tested etc.
3.3.3. Conclusion
Other
pathogens
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cell should not be affected to its reactions excepted SARS-CoV.
3.4. Cross-reactivity (Related virus or bacteria) for influenza A/B Ag
# Substance Concentration Results
1 Adenovirus 1
pfu/ml
Negative Negative Negative
2 Adenovirus 2 Negative Negative Negative
3 Coronavirus Negative Negative Negative
4 Measles virus Negative Negative Negative
5 Parainfluenza virus 1 Negative Negative Negative
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3.4.1. Protocols
- No. of tests: Triplicate per sample
- Test Kit: GenBody Influenza A/B Ag (Lot No.: FAFG04161)
- Protocol: Follow GenBody Influenza A/B Ag Kit manual
- Test result: No cross reactivity was observed for any of virus tested etc.
3.4.2. Result
6 Parainfluenza virus 2 Negative Negative Negative
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7 Respiratory syncytial virus Negative Negative Negative
8 Rhinovirus Negative Negative Negative
9 Escherichia coli
108 cells/ml
Negative Negative Negative
10 Staphylococcus epidermidis Negative Negative Negative
11 Streptococcus pneumoniae Negative Negative Negative
12 Streptococcus pyogenes Negative Negative Negative
13 Streptococcus salivarius Negative Negative Negative
3.5. Whole System Failure for SARS-CoV-2
3.5.1. Protocols
- Test purpose: To determine the variation for multiple results of samples (same concentration)
- Material: each sample spiked in matrix. Samples concentration belew under table.
- No. of Tests: singal per run, 100 tests
- Test Kit: GenBody Influenza/COVID-19 Ag Multi (Lot No.:FMOS25201)
- Protocol: Followed by GenBody Influenza/COVID-19 Ag Multi manual
3.5.2. Results
- Whole System Failure: Results was determined within intensity
- Whole system Failure rate= 0% (False negative detection number 0/100 tests)
100 samples were detected at Whole system Failure test
3.6. Additional Analytical Sensitivity / Hook effect (prozone effect)
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3.6.1. Protocols
- Material: SARS-CoV-2 isolate: USA-WA1/2020) Culture Fluid (Heat inactivated)
(Zeptomatrix corp.)
No Serial dilution Titer (TCID50/ml)
P1-H (stock) 1/1x 1.15 x 107
P2-H 1/2x 5.75 x 106
P3-H 1/4x 2.86 x 106
P4-H 1/8x 1.43 x 106
P5-H 1/16x 7.15 x 105
P6-H 1/32x 3.59 x 105
P7-H 1/64x 1.80 x 105
- Method: serial dilution of material spiked in matrix
- No. of tests: 2 repeats per sample
- Test Kit: GenBody Influenza/COVID-19 Ag Multi
- Protocol: followed by the manual of GenBody Influenza/COVID-19 Ag Multi
- Criteria of Hook effect: If intensity of the test was not further increased (= reaching to plateau
point), specify the interval as the hook effect point.
- Result
Sample P1-H P2-H P3-H P4-H P5-H P6-H P7-H
Number
of
repeats
1 Pos Pos Pos Pos Pos Pos Pos
2 Pos Pos Pos Pos Pos Pos Pos
Plateau effect Not
observed Not
observed Not
observed Not
observed Not
observed Not
observed
Not
observed
Pos: positive result, Neg: negative result
3.6.2. Conclusion
- As shown in the result tables, plateau effect was not observed at 1.15 x 107 TCID50/ml
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3.7. Hook effect for influenza A/B Ag
3.7.1. Protocols
- Test purpose: To confim the effect of high concentraion treat in samples.
- Materail: See under the table
- No. of Tests: Singular per run
- Test Kit: GenBody Influenza A/B Ag (Lot No.: FAFC13184)
- Protocol: Follow GenBody Influenza A/B Ag manual
3.7.2. Results
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- No. of Tests: Triplicates per run, 2 run a day; 5 days
- Protocol: followed by the manual of GenBody Influenza/COVID-19 Ag Multi
3.8.2. Results
- Precision: Results was determined within intensity
Lot No. FMFOS25201
Sample name Day1 Day2 Day3 Day4 Day5
Repeat 1 2 1 2 1 2 1 2 1 2
NC - - - - - - - - - -
P4 + + + + + + + + + +
P5 + + + + + + + + + +
P6 + + + + + + + + + +
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Lot No. FMFOS25202
Sample name Day1 Day2 Day3 Day4 Day5
Repeat 1 2 1 2 1 2 1 2 1 2
NC - - - - - - - - - -
P4 + + + + + + + + + +
P5 + + + + + + + + + +
P6 + + + + + + + + + +
Lot No. FMFOS25203
Sample name Day1 Day2 Day3 Day4 Day5
Repeat 1 2 1 2 1 2 1 2 1 2
NC - - - - - - - - - -
P4 + + + + + + + + + +
P5 + + + + + + + + + +
P6 + + + + + + + + + +
Positive signal: + Negative signal: -
- No. of Tests: Duplicates per run, 2 run a day; 5 days
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- Protocol: followed by the manual of GenBody Influenza/COVID-19 Ag Multi
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3.10. Reproducibility / Inter-site
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- No. of Tests: Duplicates per run, 2 run a day; 5 days
- Protocol: followed by the manual of GenBody Influenza/COVID-19 Ag Multi
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Positive Signal: + Negative signal: -
3.11. Reproducibility / Total analysis
3.12. Precision assay for influenza A/B Ag
3.12.1. Protocols
- Test purpose: To determine the variation for multiple results of samples (same concentration)
- Material: each sample spiked in matrix. Samples concentration below under table.
- No. of Tests: Triplicates per run, 2 run a day; 5 days
- Test Kit: GenBody Influenza A/B Ag (Lot No.: FAFG04161)
- Protocol: Follow GenBody Influenza A/B Ag manual
- Test guidance: Evaluation of Precision Performance of Quantitative Measurement Method ;
Approved Guideline-Second Edition, EP05-A3, NCCLS
3.12.2. Results
Lot No. FAG04161
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Sample name Day1 Day2 Day3 Day4 Day5
NC NEG NEG NEG NEG NEG
NC NEG NEG NEG NEG NEG
NC NEG NEG NEG NEG NEG
P1 POS POS POS POS POS
P1 POS POS POS POS POS
P1 POS POS POS POS POS
P2 POS POS POS POS POS
P2 POS POS POS POS POS
P2 POS POS POS POS POS
P3 POS POS POS POS POS
P3 POS POS POS POS POS
P3 POS POS POS POS POS
P4 POS POS POS POS POS
P4 POS POS POS POS POS
P4 POS POS POS POS POS
P5 POS POS POS POS POS
P5 POS POS POS POS POS
P5 POS POS POS POS POS
P6 POS POS POS POS POS
P6 POS POS POS POS POS
P6 POS POS POS POS POS
P7 POS POS POS POS POS
P7 POS POS POS POS POS
P7 POS POS POS POS POS
P8 POS POS POS POS POS
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P8 POS POS POS POS POS
P8 POS POS POS POS POS
P9 POS POS POS POS POS
P9 POS POS POS POS POS
P9 POS POS POS POS POS
POS: Positive NEG: Negative
3.13. Reproducibility / Inter-Operator
3.13.1. Protocols
- Test purpose: Experiment was performed by different operators within one laboratory) -
Material: each sample spiked in matrix. Sample concentration below under table.
- No. of Tests: Triplecates per run
- Test Kit: GenBody Influenza A/B Ag (Lot No.: FAFG04161)
- Protocol: Follow GenBody Influenza A/B Ag manual
- Test guidance: Evaluation of Precision Perfromance of Quantitative Measurement
Method ; Approved Guideline-Second Edition, EP05-A3, NCCLS
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3.14. Reproducibility / Inter-site
3.14.1. Protocols
- Test purpose: Experiment was performed by different sites within three laboratory - Material:
each sample spiked in matrix. Sample concentration below under table.
- No. of Tests: Triplicates per run
- Test Kit: GenBody Influenza A/B Ag (Lot No.: FAFG04161)
- Protocol: Follow GenBody Influenza A/B Ag manual
- Test guidance: Evaluation of Precision Perfromance of Quantitative Measurement
Method ; Approved Guideline-Second Edition, EP05-A3, NCCLS
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Technical File
3.15.1. Protocols
- Test purpose: Experiment was performed by different sites within three lot
- Material: each sample spiked in matrix. Sample concentration below under table.
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Technical File
- No. of Tests: Triplicates per run
- Test Kit: GenBody Influenza A/B Ag (Lot No.: FAFG04161, FAFG11162, FAFG18163)
- Protocol: Follow GenBody Influenza A/B Ag manual
- Test guidance: Evaluation of Precision Performance of Quantitative Measurement
Method ; Approved Guideline-Second Edition, EP05-A3, NCCLS
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Technical File
3.16.1. Protocols
- Material: each sample spiked in matrix. Sample concentration below under table.
- No. of Tests: Triplicates per run
- Test Kit: GenBody Influenza A/B Ag (Lot No.: FAFG04161)
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Technical File
- Protocol: Follow GenBody Influenza A/B Ag manual
- Test guidance: Evaluation of Precision Performance of Quantitative Measurement Method ;
Approved Guideline-Second Edition, EP05-A3, NCCLS
3.16.2. Results
Speci
men Rep
eat 1
D 2
D 3
D 4
D 5
D 6
D 7
D 8
D 9
D 10
D 11
D 12
D 13
D 14
D 15
D 16
D 17
D 18
D 19
D 20
D
N 1 N N N N N N N N N N N N N N N N N N N N
2 N N N N N N N N N N N N N N N N N N N N
3 N N N N N N N N N N N N N N N N N N N N
P1
1 P P P P P P P P P P P P P P P P P P P P
2 P P P P P P P P P P P P P P P P P P P P
3 P P P P P P P P P P P P P P P P P P P P
P2
1 P P P P P P P P P P P P P P P P P P P P
2 P P P P P P P P P P P P P P P P P P P P
3 P P P P P P P P P P P P P P P P P P P P
P3
1 P P P P P P P P P P P P P P P P P P P P
2 P P P P P P P P P P P P P P P P P P P P
3 P P P P P P P P P P P P P P P P P P P P
P4
1 P P P P P P P P P P P P P P P P P P P P
2 P P P P P P P P P P P P P P P P P P P P
3 P P P P P P P P P P P P P P P P P P P P
P5
1 P P P P P P P P P P P P P P P P P P P P
2 P P P P P P P P P P P P P P P P P P P P
3 P P P P P P P P P P P P P P P P P P P P
P6
1 P P P P P P P P P P P P P P P P P P P P
2 P P P P P P P P P P P P P P P P P P P P
3 P P P P P P P P P P P P P P P P P P P P
P7
1 P P P P P P P P P P P P P P P P P P P P
2 P P P P P P P P P P P P P P P P P P P P
3 P P P P P P P P P P P P P P P P P P P P
P8
1 P P P P P P P P P P P P P P P P P P P P
2 P P P P P P P P P P P P P P P P P P P P
3 P P P P P P P P P P P P P P P P P P P P
P9
1 P P P P P P P P P P P P P P P P P P P P
2 P P P P P P P P P P P P P P P P P P P P
3 P P P P P P P P P P P P P P P P P P P P
P: positive, N: negative, D: days
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4. Clinical Evaluation/Diagnostic sensitivity & specificity for SAR-CoV-2
4.1. Test Protocol
- Material : 130 clinical samples(30 positive specimens, 100 negative specimens/ see under
each result)
- No. of Tests : Single test per sample
- Test Kit : GenBody Influenza/COVID-19 Ag Multi
- Protocol: Follow GenBody Influenza/COVID-19 Ag Multi manual
- Test guidance : User Protocol for Evalution Qualitative Test Performance ;
Approved Guideline, EP12-A2, NCCLS
- Result analysis : Each target in positive samples were tested Real-Time PCR kit
- * User Protocol for Evalution Qualitative Test Performance ; Approved Guideline, EP12-
A2, NCCLS
4.2. Test Result
CT ≤ 30
Real-time RTPCR
Total Positive Negative
GenBody
INFLUENZA/COVID-
19 Ag Multi Test
Positive 122 3 125
Negative 4 366 370
Total 126 369 495
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-Positive Percent Agreement:
1) CT ≤ 30: 96.83% (95% CI: 92.07% to 99.13%)
2) CT > 30: Less than 50%
-Negative Percent Agreement: 99.18% (95% CI: 97.25% to 99.70%)
-Positive Predictive Value: 96.83% (95% CI: 92.00% to 98.78)
-Negative Predictive Value: 98.92% (95% CI: 97.21% to 99.59%)
5. Clinical Evaluation/Diagnostic sensitivity & specificity for influenza A/B Ag
5.1. Test Protocols
- Material : clinical specimen(see under each result)
- No. of Tests : 53 Influenza A, 62 Influenza B, Single test per sample
- Test Kit : GenBody Influenza A/B Ag
- Protocol: Follow GenBody Influenza A/B Ag manual
- Clinical evaluation site: Korea University Guro Hospital in Korea
- Test guidance : User Protocol for Evalution Qualitative Test Performance ; Approved
Guideline, EP12-A2, NCCLS
- Result analysis : Each target in positive samples were tested between RT-PCR
confirmed.
Comparison of GenBody Influenza A/B Ag and Asan Easy Test Influenza A/B for
Influenza Type A and Type B result.
- * User Protocol for Evalution Qualitative Test Performance ; Approved Guideline,
EP12-A2, NCCLS
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5.2. Test Results
5.2.1. Sensitivity and specificity
6. Performance claim in IFU Sample type: Nasopharyngeal swab and oropharyngeal swab from human