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CT/NG & HPV Testing

Chlamydia trachomatis and Neisseria gonorrhoeae detection (CT/NG)

The cobas® 4800 CT/NG Test (CE-IVD) 

For information on this product, please contact our technical hotline at 1-877-273-3433.

 

The COBAS® AMPLICOR CT/NG Test (CE-IVD & FDA-IVD)

CT-Amplicor

The COBAS® AMPLICOR (CT/NG) Test is a qualitative in vitro test for the detection of C. trachomatis and/or N. gonorrhoeae DNA in urine from males and females, in endocervical swab specimens, and in male urethral swab specimens. The test utilizes the polymerase chain reaction (PCR) nucleic acid amplification technique and nucleic acid hybridization for the detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae in urogenital specimens using automated COBAS® AMPLICOR analyzers.

The COBAS® AMPLICOR CT/NG Test is based on four major processes: specimen preparation; PCR amplification of target DNA using target specific complementary biotinylated primers; hybridization of the amplified products to oligonucleotide probes specific to the target(s); and detection of probe-bound amplified products by colorimetric determination.

  

Human Papillomavirus decection (HPV)

  • The cobas® 4800 HPV Test (CE-IVD)
  • AMPLICOR HPV Test
  • LINEAR ARRAY HPV Genotyping Test (CE-IVD)

 

The cobas® 4800 HPV Test (CE-IVD)

For information on this product, please contact our technical hotline at 1-877-273-3433.

 

AMPLICOR HPV Test (CE-IVD)

amplicor_hpv

The Roche Diagnostics AMPLICOR HPV Test (CE-IVD) is a PCR-based test for detecting the 13 high-risk HPV genotypes and is registered for use in the European Union and other countries that accept CE Mark certification. It is also approved in Canada and Japan.

Human papillomavirus (HPV) is required for the development of cervical cancer and its high-grade CIN2 & CIN3 precursor lesions

  • HPV is responsible for more than 99% of cervical cancers worldwide.
  • HPV is the most common sexually transmitted infection.
  • Up to 75% of all women experience exposure at some point in their lifetime.
  • Only a subset of HPV genotypes are associated with cervical cancer and its high-grade precursor lesions, and are defined as high risk.
  • Persistent infection with one or more of the 14 HR-HPV genotypes is the principle cause of cervical cancer and its precursor, cervical intraepithelial neoplasia (CIN)6.

Intended use

The AMPLICOR Human Papilloma Virus (HPV) Test (CE-IVD) is a qualitative in vitro test for the detection of human papillomavirus in clinical specimens. The test uses amplification of target DNA by the polymerase chain reaction (PCR) and nucleic acid hybridization for the detection of high risk (HR) HPV DNA genotypes in cervical cells collected in liquid media.

You benefit from:  

  • 96-microwell plate format
  • Uses PCR technology to target and amplify HPV DNA from 13 high-risk genotypes
  • Reproducible results to minimize repeat testing and provide definitive answers
  • No indeterminate zone
  • Requires a sample size of only 250 microliters, enabling adequate HPV diagnosis even after completion of liquid cytology screening
  • Concurrent isolation and amplification of the ß-globin gene assesses cellular adequacy and inhibition for each specimen
  • Validated on common liquid based cytology media: PreservCyt® (Hologic) or SurePath® (BD)

HPV screening offers more accuracy than cytology

  • Traditionally, cervical cancer screening was based on the Pap smear. There has been a marked reduction in incidence and mortality rates of SCC of the cervix in countries with established Pap screening programs. However, these Pap programs have not affected the incidence of ADC, which continues to rise
  • Despite its success as a method of cancer screening, the Pap smear has a number of significant limitations — it has been reported that 34-80% of women with precancer are correctly identified using cytology where the HPV sensitivity for detecting precancer is 95%.
  • HPV testing for the detection of cervical cancer and its precursor lesions had significantly improved sensitivity than cytology, with slightly less specificity, in a randomized study of 10,154 women aged 30 to 69 years.
  • HPV testing for the detection of cervical cancer and its precursor lesions had significantly improved sensitivity than cytology, with slightly less specificity, in a randomized study of 10,154 women aged 30 to 69 years.
  • A recent meta-analysis, of European and North American studies of over 60,000 women, found HPV testing to be more sensitive in the detection of cervical cancer and its precursor lesions in comparison to cytology.

 

LINEAR ARRAY HPV Genotyping Test (CE-IVD)

lineararray 

The need for HPV genotyping

Although the majority of HPV infections clear spontaneously, persistence of HR-HPV is a significant risk factor among women in the general screening population for the development of cervical cancer. Persistent HPV infection with specific high-risk HPV types is an indicator of high grade lesions (HSIL). HPV genotyping assays may be used in cytology negative, HR-HPV-positive women over age 30 in the same manner as HPV triage testing is currently utilized in women with ASC-US or BMD cytology.

A CE-IVD Test Kit for HPV genotyping

The LINEAR ARRAY HPV Genotyping Test is registered for use in the European Union for the detection of 37 high- and low-risk human papillomavirus genotypes, including those considered a significant risk factor for HSIL progression to cervical cancer. HPV genotypes include 6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 45, 51, 52, 53, 54, 55, 56, 58, 59, 61, 62, 64, 66, 67, 68, 69, 70, 71, 72, 73 (MM9), 81, 82 (MM4), 83 (MM7), 84 (MM8), IS39, and CP6108.

Intended use

The LINEAR ARRAY HPV Genotyping Test is a qualitative in vitro test for the detection of human papillomavirus in clinical specimens. The test utilizes amplification of target DNA by the polymerase chain reaction (PCR) and nucleic acid hybridization and detects 37 anogenital HPV DNA genotypes in cervical cells collected in PreservCyt® solution.

You benefit from:

  • IVD HPV genotyping test with CE Mark certification. 
  • Designed to identify 37 HPV genotypes. 
  • Low and high ß-globin reference lines. 
  • Designed to detect genotypes in the presence of multiple infections.   

HPV genotyping offers the physician the ability to identify women at risk and optimize treatment strategies 

  • The goal of type-specific detection of HPV is to further stratify women with normal cytology who are HPV positive into different risk categories:
    - Identifying infection with HPV Type 16 and Type 18 among these women justifies immediate colposcopy.
    - Women with other HR-HPV infections at lower risk can be managed less aggressively.
  • Genotyping provides physicians with actionable information to treat the highest risk patients immediately. 
  • The current paradigm of "watchful waiting" can be a cause of concern to both patients and physicians

genotyping

Leading the way in HPV discovery

Roche research assays and PCR technology have been widely used in landmark epidemiology studies around the world — 40 investigators and 185 publications — to characterize the incidence and distribution of HPV genotypes and for classification of the HPV types as they relate to cervical cancer.