BZ IsoMDx COVID-19 kit is an in vitro diagnostic using RT-LAMP(Real time Reverse Transcription Loop-mediated

Isothermal Amplification) assay for qualitative detection of coronavirus disease (COVID-19) from RNA extracted

from human nasopharyngeal swab, oropharyngeal swab and sputum

Detect two gene regions and simultaneously detect N gene as well as RdRP gene of SARS-CoV-2.

Endogenous control included for sample extraction and amplification efficiency verification

CONCLUSION

BZ IsoMDx COVID-19 kitshowed tsreults inlowest conetraion as1/04 diluted RNAin twospecimns. • In twospecimns, AlpexTM 2019-nCoV Asay howed tsreults inlow cnetraion as1/04 diluted RNA(asopharyngeal
swab), 1/05 diluted RNA(Sputm). • BZ IsoMDx COVID-19 kitdectd heSAR-CoV2 equaly toAlpexTM 2019-nCoV Asay
BZ IsoMDx COVID-19 kits enable todetc SAR-CoV2 asmuch asthe AlpexTM 2019-nCoV Asay

Analytical sensitivity (Limit of Detection) To determine the analytical sensitivity of BZ IsoMDx COVID-19 kit, the upper respiratory tract specimens (Nasopharyngeal swab) were diluted with internal standard material, and was tested 20 times.

The concentration of 100% or more positive result was determined as the minimum detection limit.

The limit of detection is 102 copies/µL for the specimens from the upper respiratory tract regardless of the PCR systems including CFX96TM Dx System (Bio-Rad)..

Analytical sensitivity (Cut off Value) The cut off value was determined as 30 based on the Ct value, which was set using the LOD (Limit of detection) test result value.

Analytical specificity (Cross Reactivity) To evaluate the cross reactivity of BZ IsoMDx COVID-19 kit, the possible cross reactive pathogens as listed in the table below were tested 3 repeated times.

As a result, no cross reactivity was observed for the pathogens showing the similar symptoms or alpha coronavirus.

- Mycoplasma Pneumoniae - Streptococcus Pneumoniae - Influenza A Virus H1 - Influenza A Virus H3 - Influenza A Virus H1N1 - Influenza B Virus1 - Human Respiratory Syncytial A Virus (RSV) - Human Respiratory Syncytial B Virus (RSV) - Adeno Virus - Para Influenza Virus - Human Corona Virus, OC43 - Human Corona Virus, NL63 - Human Corona Virus, 229E - Human Boca Virus - Meta Pneumoniae - Huma Rhino Virus - Human Entero Virus - Staphylococcus Aureus Strain - Middle East Respiratory Syndrome Corona Virus - Human Astro Virus

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Analytical specificity (Interference)

To test the effect of the possible interfering substances BZ IsoMDx COVID-19 kit was tested 3 repeated times using specimen prepared by adding the materials listed below.

(Mucin 1%, Acetyl salicylic Acid 15mg/mL, NaCl 7.4mg/mL, Oxymetazoline 20%, Hemoglobin 0.2%, Whole blood 3%) Precision (Reproducibility)

To evaluate reproducibility of BZ IsoMDx COVID-19 kit for nasopharyngeal swab from the upper respiratory tract from the lower respiratory tract, one run of test were performed each day.