Introduction
IVD R&D
iLAMP Novel-CoV19 Detection Kit
| Product Overview
An in vitro diagnostic medical device designed to rapidly and accurately detect SARS-CoV-2 in respiratory specimens from patients suspected of having a respiratory infection. Detection is based on real-time reverse transcription loop-mediated isothermal amplification (RT-LAMP PCR).
Unlike conventional RT-PCR methods, this assay allows amplification at a constant temperature (isothermal), enabling results in under 30 minutes.
| Product Specifications
– Target Pathogen: SARS-CoV-2 (2019-nCoV) RNA
– Detection Method: Real-Time RT-LAMP PCR
– Compatible Equipment: CFX96™ Real-Time PCR System (Bio-Rad)
-Time to Results: 30 minutes
– Sample Types: Nasopharyngeal and oropharyngeal swabs
Discovery of New Biomarkers
Prototype Production
Clinical Trials and Regulatory Approval
Finished Product Manufacturing
Product Launch
iONE Neutralized Antibody Detection Kit
| Product Overview
In Vitro Diagnostic Device for the Qualitative Detection of SARS-CoV-2 Neutralizing Antibodies and IgG Antibodies
This product is designed to qualitatively detect neutralizing antibodies and IgG antibodies generated by SARS-CoV-2 infection or COVID-19 vaccination. It delivers rapid results within 25 to 30 minutes using a simple blood sample (whole blood, plasma, or serum).
| Product Specifications
Target Analytes: SARS-CoV-2 Neutralizing Antibodies and IgG Antibodies
Sample Types: Whole Blood, Plasma, Serum
Sample Volume: 10 µL or 20 µL
Test Time: 25 to 30 minutes
Sensitivity (PPA): 96.4% (based on ppRNT50)
Specificity (NPA): 100% (based on ppRNT50)
Discovery of New Biomarkers
Prototype Production
Clinical Trials and Regulatory Approval
Finished Product Manufacturing
Product Launch
iONE Oral Cancer Detection Kit
| Product Overview
In Vitro Diagnostic Device for the Rapid and Non-Invasive Detection of Oral Cancer
This device enables quick and accurate diagnosis of oral cancer using a non-invasive method. It delivers results within 15 to 20 minutes using only a saliva sample.
| Product Specifications
Target Analytes: 4 Oral Cancer Biomarkers
Sample Type: Saliva
Sample Volume: 15–20 µL
(Optimized volume for improved diagnostic accuracy)Test Time: 15–20 minutes
Detection Method: Immunoassay
Discovery of Newly Added Biomarkers
Prototype Production
Clinical Trials and Regulatory Approval
Finished Product Manufacturing
Product Launch
| iONE Peri-Implantitis Detection Kit
| Product Overview
In Vitro Diagnostic Device for the Simultaneous Detection of Periodontitis and Peri-Implantitis Using Saliva-Based Immunoassay (POCT)
This device enables rapid, non-invasive diagnosis of both periodontitis and peri-implantitis using saliva as a sample through a point-of-care immunoassay.
By detecting immunological biomarkers, the device helps predict the potential onset of disease, supporting early detection and preventive care.
| Product Specifications
Target Analytes: 4 biomarkers associated with periodontitis and peri-implantitis
Sample Type: Saliva
Sample Volume: 15–20 µL
Test Time: 15–20 minutes
Detection Method: Immunoassay
Discovery of Newly Added Biomarkers
Prototype Production
Clinical Trials and Regulatory Approval
Finished Product Manufacturing
Product Launch
