Search

cobas® 4800 Sisteminde kullanıma yönelik cobas® HCV GT

Cobas® 4800 Sisteminde kullanıma yönelik cobas® HCV GT ürün görseli

Klinik ihtiyaçların karşılanması

HCV genotipinin tayini
 

Tedaviye başlanmadan önce hepatit C virüsü (HCV) genotipinin tayini, uluslararası HCV tedavi kılavuzlarına eklenmiştir.1-3

cobas® HCV GT, kronik HCV enfeksiyonu olan kişilerden elde edilen insan plazması veya serumunda cobas® 4800 sistemi kullanılarak HCV genotipleri 1 ila 6 ve genotip 1 alt tipleri A ve B'nin kalitatif tayinine yönelik bir yüksek duyarlılığa sahip, gerçek zamanlı PCR testidir.4

cobas® HCV GT, dizilemeye benzer düzeyde bir genotipleme ve alt tipleme doğruluğu elde etmek ve karma enfeksiyonlarda her iki genotipi de 1:100'lük bir oranda saptayabilmek için HCV genomundaki üç farklı hedef bölgeyi (5’-UTR, Core, NS5B) kullanmaktadır.4

Özellikler ve avantajlar

  • Karma enfeksiyonlarda minör genotipi ortalama %86 (10:1'lik karışımlar) ve %63 (100:1'lük karışımlar) düzeyinde saptar
  • cobas® HCV GT, 8 saatlik bir vardiyada 3 çalışmayı %60 daha az manuel çalışma süresi ile tamamlayabilir, bu ise 90 numune/günlük maksimum iş üretimi anlamına gelir
  • Daha az manuel müdahale ve manuel çalışma süresi içeren test tasarımı
Bize Ulaşın
Kullanım amacı

Kullanım amacı

cobas® HCV GT, kronik HCV enfeksiyonu olan kişilerden elde edilen insan plazması veya serumunda cobas® 4800 sistemi kullanılarak (otomatik numune işlemede cobas x 480 cihazı ve otomatik amplifikasyon ve saptamada cobas z 480 analizörü) Hepatit C Virüsü (HCV) genotipleri 1 ila 6 ve genotip 1 alt tipleri a ve b'nin kalitatif tayinine yönelik bir in vitro nükleik asit amplifikasyon testidir. cobas® HCV GT, antiviral tedavi için kronik HCV enfeksiyonu olan kişilerin seçilmesinde ve antiviral tedavi reçete bilgilerine göre tedavi rejimlerinin süresini belirlemede kullanıma yöneliktir.

Ruhsat durumu

CE-IVD

Kaynaklar

 

  1. Dünya Sağlık Örgütü (DSÖ). Bilgi Formu No. 164: Hepatitis C. http://www.who.int/mediacentre/factsheets/fs164/en/. Erişim tarihi: 13 Mayıs 2016.
  2. EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol. 2017;66(1):153–194.
  3. AASLD HCV Guidance. Hepatitis C Guidance: AASLD-IDSA Recommendations for Testing, Managing, and Treating Adults Infected With Hepatitis C Virus. Hepatology. 2015.
  4. cobas® 4800 sisteminde kullanıma yönelik cobas® HCV GT prospektüsü.

Performans

  • Numune türleri

    EDTA'lı plazma, Serum

  • Numune işleme hacmi

    400 µL

  • Genotip doğruluğu

    Genotipler 1 ila 6: %99,7; Genotip 1 alt tipleri 1a ve 1b: %100

     

  • Saptanan genotipler

    HCV genotipleri 1 – 6 ve genotip 1 alt tipleri a ve b

İlgili testler

cobas® TaqMan® HCV Testi v2.0
High Pure Sistemi ile Birlikte Kullanıma Yönelik COBAS® TaqMan® HCV Testi v2.0
COBAS® AmpliPrep/COBAS® TaqMan® HCV Testi, v2.0: Kalitatif ve Kantitatif ürün görseli
COBAS® AmpliPrep/COBAS® TaqMan® HCV Testi, v2.0: Kalitatif ve Kantitatif
cobas® HCV Testi ürün görseli
cobas® HCV Testi
IVD For in vitro diagnostic use.
MagNA Pure 24 Instrument
MagNA Pure 24 Instrument A fully-automated clinical nucleic acid extraction system that brings you walkaway automation for up to 24 samples. The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications.The main features of the system are:Scalable purification of 1 to 24 samplesPrimary/secondary tube handlingInventory and sample management via barcodesEfficient order management via host
IVD For in vitro diagnostic use.
MagNA Pure 96 Instrument
MagNA Pure 96 Instrument High-throughput robotic workstation for fully automated purification of nucleic acids from up to 96 samples. Magnetism is the underlying principle of the automated nucleic acid isolation performed by the highthroughput MagNA Pure 96 System. The MagNA Pure 96 Instrument performs automated nucleic acid purification from samples of up to 1000 μl that are pipetted into a 96-well processing cartridge. It comprisesa magnetic glass particles (MGP) based purification process as well as protocols that support isolation of RNA, DNA and tNA from different sample materials. The MagNA Pure 96 System permits automated nucleic acid purification that matches the high standards of speed, accuracy and reliability in PCR/ RT-PCR of the LightCycler® Systems.
IVD For in vitro diagnostic use.
cobas® Liat Analizörü görseli
cobas® liat system The cobas® liat analyzer is an automated nucleic acid test instrument, that when used together with cobas® liat assay tubes to perform in vitro diagnostic tests, is referred to as the cobas® liat system. In conjunction with a cobas® liat assay tube, the instrument performs reagent preparation, target enrichment, inhibitor removal, nucleic acid extraction, polymerase chain reaction (PCR) amplification, real-time detection, and result interpretation to automate the detection or quantification of nucleic acid targets in a biological sample.Addition for Canada only:The cobas® liat system is intended for professional use in a clinical laboratory setting or Point of Care (POC) location.
Country Specific Labeling See country-specific product labeling for regulatory status.
<b>cobas z</b> 480 analyzer
cobas® z 480 analyzer The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as a diagnostics system providing real time PCR amplification and detection for human samples within the system.The cobas x 480 instrument and cobas z 480 analyzer are to be used by trained laboratory professionals.Intended Use statements for the assays on the cobas® 4800 System are located within the Instructions for Use for respective tests run on the system.
IVD For in vitro diagnostic use.
cobas® 5800 sistemi
Yeniliği erişilebilir hale getirdik The cobas® 5800 system supports an automated and integrated workflow to run polymerase chain reaction (PCR) based nucleic acid testing (NAT) for use by trained professionals in laboratory settings.The cobas® 5800 system combines the functionalities of instrumentation, consumables, reagents, and data management to provide an efficient workflow from sample processing to result interpretation.
IVD For in vitro diagnostic use.
cobas® 6800 Sistemi
cobas® 6800 System The cobas® 6800/8800 Systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT).The cobas® 6800/8800 Systems combine the functionalities of instrumentation, consumables, reagents, and data management to provide an efficient workflow from sample processing to result interpretation.
IVD For in vitro diagnostic use.
cobas® 8800 Sistemi görseli
cobas® 8800 System The cobas® 6800/8800 Systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT).The cobas® 6800/8800 Systems combine the functionalities of instrumentation, consumables, reagents, and data management to provide an efficient workflow from sample processing to result interpretation.
IVD For in vitro diagnostic use.
cobas® prime Pre-analitik Sistem
cobas® prime pre-analytical system Content was migrated to RDK.
GLU For general laboratory use.
FLOW Solution
FLOW Solution FLOW Flex For cost efficiencyStart simple by combining primary sample handing and PCR setup in a single instrument:Up to 288 samples and 1,400 results per day*Easily add additional devices as throughput increasesSample handling and PCR setup as a combined system for cost and space efficiencyIntegrated software connecting instrument workflow to your lab’s LISNon-linear workflowFLOW Classic For high throughputPlan for expansion by utilizing dedicated instruments for sample handling and PCR setup:Up to 384 samples and 1,900 results per day*Add additional instruments as throughput increases—up to 1,000 samples and 5,000 test results per dayTwo pipetting instruments for high throughput efficiencyIntegrated software connecting instrument workflow to your lab’sLIS Linear workflow
IVD For in vitro diagnostic use.
cobas® 4800 Sistemi görseli
cobas® 4800 system The cobas® 4800 System is intended to be used as an in vitro diagnostics system providing sample preparation, amplification and detection of specific targets from human samples. It integrates fully automated total nucleic acid isolation directly from primary and secondary tubes, automated PCR setup, and real time PCR.
cobas® SARS-CoV-2 test kiti
cobas® SARS-CoV-2 Testi
cobas® 4800 Sisteminin görseli

İlgili sistemler

cobas® 4800 Sistemi

Yüksek verimli, esnek iş akışları ve birleştirilmiş test menüsü her sonuçta güven sağlar. Otomatik PCR kurulumu ve analizi kaynaklarınızdan en iyi şekilde yararlanmanıza yardımcı olur ve hata oranını düşürür.