| 학회 | 한국공업화학회 |
| 학술대회 | 2022년 봄 (05/11 ~ 05/13, 제주국제컨벤션센터(ICC JEJU)) |
| 권호 | 26권 1호 |
| 발표분야 | 포스터-생물공학 |
| 제목 | Clinical validation of Fully Automatic Nucliec Acid Analyser : LabGenius |
| 초록 | Using the automativ nucleic acid analyser(LabGenius, Suwon, Korea) which we have developed during last years, we have evaluated the clinical performance throughout the clinical semens. Two of sexually transmited diseases (chlamydia and nisseria) would be detected by the disposable cartridge (LabGenius C-T/NG-BMX) using urine and cervical swab of human specimen. The basic processes of the nucleic acid test, i.e. nucleic acid extraction, amplification and detection would be operated automatically in the LabGenius and cartridge. About 480 samples of human were tested and the true value of the sample were validated by another qPCR test kit, Total clinical sensitivity and specificity are 96.4 and 96.6% for CT and 94.6% and 100% for NG, resectively. These data show that LabGius system could be used as an IVD for automatic system. |
| 저자 | 박아름1, 박애자2 |
| 소속 | 1Biomedux Co., 2Suwon |
| 키워드 | nucleic acid test; automatic; clinical validation; modelcular diagnostics |
