제품/서비스

  • DiaPlexQ™ MTCNTM Detection Kit_CE IVD.png
  • DiaPlexQ™ MTC/NTM Detection Kit MTC & NTM 단독감염 및 중복감염여부를 정성 검출하는 검사시약
    Real-Time PCR
    의료기기 (제허 16-269호)
    CE-IVD

    본 제품은 Real-Time PCR 기술을 이용하여 결핵균 (MTC)과 비결핵균 (NTM)의 co-infection 및 single infection을 검사하는 키트 입니다. 키트의 구성은 검체 전처리를 위한 시약 (Pre-Solution I, II, Cat. No. SQD21-K100 포함) 및 DNA 추출 시약 (DNA Extraction Solution, Cat. No. SQD21-K100 포함), Real-Time PCR 진단 시약 (Cat. No. SQD20-K100, SQD21-K100 공통) 으로 구성되어 있습니다.
    Real-Time PCR 진단 시약은 UDG system을 적용하여 PCR product에 의한 carryover contamination을 방지, 오염에 의한 위양성의 가능성을 줄였고, 사용의 편리함을 위해 enzyme과 dNTP, buffer 등을 섞은 Smart mix 형태로 제조하여 사용자가 template DNA와 primer & probe mixture만 첨가하여 간편하게 PCR을 수행할 수 있습니다. 또한 positive control인 Control Template가 제공됩니다.

제품사양
제품사양
DiaPlexQ™ MTC/NTM Detection Kit DiaPlexQ™ MTC/NTM Detection Kit
ver. 3.0
DiaPlexQ™ MTC/NTM Detection Kit
ver. 4.0
Detection target MTC (2 species): IS6110
NTM (13 species): 16s rRNA
MTC (2 species): IS6110, MPB64
NTM (13 species): 16s rRNA
MTC (5 species): IS6110, MPB64
NTM (6 species): 16s rRNA
Registration KFDA(제허 16-269호, 3등급 고위험성감염체유전자검사시약),
CE-IVD
CE-IVD CE-IVD
Detection technology Real-Time PCR
Specimen type 객담(Sputum), 비인두 swab(Nasopharyngeal swab), 인두 비강 흡입(Nasopharyngeal aspirate), 기관지폐포 세척액(Bronchoalveolar lavage, BAL)
* SQD21-K100 제품은, 비인두 swab(Nasopharyngeal swab), 인두 비강 흡입(Nasopharyngeal aspirate), 기관지폐포 세척액(Bronchoalveolar lavage, BAL) sample만 적용됩니다.
Analytical sensitivity 10 copies
Compatible instruments* ABI 7500 / 7500 Fast Real-Time PCR System (Applied Biosystems)
CFX96™ Real-Time PCR System (Bio-Rad)
PCR running time ~ 1 hr 20 min
제품특징
제품특징

- HotStart PCR system : Ultra high specific and sensitive result
- DnaFree™ system : No host genomic DNA contamination ( DiaPlexC ™)
- UDG system : No carryover contamination
- Multiplex PCR system : Multiple targets in a single reaction
- Reliable system : Automatic PCR control
- Positive control included
- DNA extraction solution included (Cat. No. SQD21-K100)
- Easy-to-use master mix
- CE certification

실험데이터
2-1.JPG
2-2.JPG
2-3.JPG
Sample type FAM HEX Cy5 Result
Positive Control + + + Valid
Negative Control - - + Valid
NTC(Non-Template Control) - - + Valid
Sample case 1 + + +/- MTC, NTM (Co-infection)
Sample case 2 + - +/- MTC
Sample case 3 - + +/- NTM
Sample case 4 - - + Negative
Sample case 5 - - - Required   re-experiment
인용&논문
  1. Korean J Clin microbial, Seong Deok Lee, Hye Young Lee, Hyun Chul Kim, Soo Young Kim,

    Mycobacterium tuberculosis and Non-Tuberculous Mycobacteria by PCR Assay.

  2. Ryan KJ, Ray CG (Editors) (2004).

    Sherris Medical Microbiology (4th ed.). McGraw-Hill. Clinical Characteristics of Non-Tuberculous Mycobacterial Pulmonary Disease in a National Tuberculosis Hospital.

  3. Sun-Pil Choi, M.D., Bong-Keun Lee M.D.1, Jin-Hong Min, M.D., Jin-Hee Kim, M.D.

    Pathogenic Classification and Clinical Charateristics of Non-Tuberculous Mycobacterial Pulmonary Disease in a National Tuberculosis Hospital.

주문정보 (Ordering information)
Technology Cat. No. Product
Real-time PCR SQD21-K100 DiaPlexQ™ MTC/NTM Detection Kit (w/Ext.)
SQD20-K100 DiaPlexQ™ MTC/NTM Detection Kit
SQD26-K100 DiaPlexQ™ MTC/NTM Detection Kit (w/Ext.)- Ver.3.0
SQD25-K100 DiaPlexQ™ MTC/NTM Detection Kit- Ver.3.0
SQD28-K100 DiaPlexQ™ MTC/NTM Detection Kit (w/Ext.)- Ver.4.0
SQD27-K100 DiaPlexQ™ MTC/NTM Detection Kit- Ver.4.0