Manufacturers OEM

QIAGEN Lake Constance GmbH

Jacques-Schiesser-Str. 3 , 78333 Stockach
Germany

Telephone +49 7771 9166-0
Fax +49 7771 9166-218
info-qlc@qiagen.com

Trade fair hall

  • Hall 3 / D84
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 3): stand D84

Fairground map

MEDICA 2016 fairground map: Hall 3

Our range of products

Product categories

  • 03  Diagnostics
  • 03.01  Clinical chemistry
  • 03.01.07  Gene tests / molecular biological diagnostic

Gene tests / molecular biological diagnostic

Our products

Product category: Analyser appliances

For advanced DNA, RNA, and protein analyses

•A comprehensive workbench for advanced DNA, RNA, and protein analyses
•An intuitive graphical user-interface
•Support for efficient data sharing between colleagues and collaborators
•Frequent updates with the latest scientific developments

CLC Main Workbench is a comprehensive analysis package for advanced DNA, RNA, and protein analyses. The workbench is available for Windows, Mac OS X, and Linux platforms. CLC Main Workbench is continuously evolving and is frequently updated to keep the user informed about the latest scientific developments. It supports classical sequencing analysis features, such as gene expression analysis, assembly and read mapping of Sanger sequencing data, primer design, molecular cloning, phylogenetic analyses, and sequence data management.

Performance

Intuitive and user-friendly
The software is made by biologists for biologists. Its intuitive graphical interface and user-friendly analysis capabilities simplify data analysis.

Cross-platform
CLC Main Workbench is a cross-platform desktop application and is compatible with Windows, Mac OS X, and Linux platforms.

A comprehensive analysis package
CLC Main Workbench includes a number of features for advanced DNA, RNA, and protein analyses.

Applications

CLC Main Workbench includes numerous features for DNA, RNA, and protein sequence data analysis such as assembly of DNA sequencing data, primer design, molecular cloning, gene expression analysis, phylogenetic analysis, and RNA structure prediction.

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Product category: Analyser appliances

For whole genome amplification of bisulfite converted DNA for PCR analyses

•High yield of bisulfite converted DNA for multiple PCRs
•Representative amplification from bisulfite converted DNA
•Convenient one-step reaction setup

The EpiTect Whole Bisulfitome Kit provides DNA polymerase, buffers, and reagents for amplification of the entire bisulfite converted genome — the bisulfitome — using multiple displacement amplification technology (MDA). The EpiTect Whole Bisulfitome Kit has been specially developed for the amplification of DNA after conversion with EpiTect Bisulfite Kits. It uses proven REPLI-g technology and has been adapted to the specific requirements of bisulfite converted DNA (smaller DNA fragment size and altered nucleotide composition due to bisulfite conversion), while maintaining the converted sequence representation. Typical DNA yields from the EpiTect Whole Bisulfitome Kit are 1–3 μg per reaction, sufficient for up to 300 PCR analyses from just a single EpiTect bisulfite reaction.

The EpiTect Whole Bisulfitome Kit is the ideal tool to provide sufficient DNA for all downstream methylation analyses, whenever bisulfite converted DNA is limited. This whole bisulfitome amplification (WBA) procedure provides high yields of bisulfite converted DNA with accurate locus representation, when used in conjunction with EpiTect Bisulfite Kits. The EpiTect Whole Bisulfitome Kit has outperformed amplification kits tested from other suppliers (see figures "High amplification efficiency" and "Reliable whole bisulfitome amplification").

Principle

Methylation analysis of genomic DNA sequences can be limited by the small amount of sample available. The EpiTect Whole Bisulfitome Kit provides highly uniform amplification across the entire bisulfite converted genome, with negligible sequence bias (see figure "EpiTYPER MALDI-TOF analysis of WBA DNA"). The method is based on isothermal multiple displacement amplification (MDA) technology. A uniquely processive DNA polymerase with a 3'→5' exonuclease proofreading activity maintains high fidelity during the replication process.

The EpiTect Whole Bisulfitome Kit has been specially developed using proven REPLI-g technology and has been adapted to the special requirements of bisulfite converted DNA (smaller DNA fragment size and changed nucleotide composition due to bisulfite conversion), while maintaining the converted sequence representation. Best results are obtained when used in combination with EpiTect Plus Bisulfite Kits, which contain a uniquely formulated DNA Protect system. This enables effective DNA denaturation, which is necessary for complete cytosine conversion, and prevents the excessive DNA fragmentation usually associated with high temperature and low pH conditions of the bisulfite conversion reaction. Preventing DNA fragmentation enables subsequent amplification of large DNA fragments. Typically, DNA yields of 1–3 μg are generated per reaction using the EpiTect Whole Bisulfitome Kit.

Procedure

The convenient one-step reaction setup involves incubating bisulfite converted template DNA with a mixture of reaction buffer and REPLI-g DNA polymerase. After heat inactivation of the polymerase, the amplified DNA is ready for analysis or storage (see figure "WBA procedure").

Accessing epigenetic information is of prime importance for many areas of biological and medical research — particularly oncology, but also stem cell research and developmental biology. However, the analysis of changes in DNA methylation is challenging due to the lack of standardized methods for providing reproducible data particularly from limited sample material. With its newly introduced EpiTect products, QIAGEN makes available standardized, pre-analytical and analytical solutions, from DNA sample collection, stabilization and purification, to bisulfite conversion and real-time or end-point PCR methylation analysis or sequencing (see figure "Standardized workflows in epigenetics").

Applications

The EpiTect Whole Bisulfitome Kit is the ideal tool to provide sufficient DNA for all downstream methylation analyses, whenever bisulfite converted DNA is limited. The amplification reaction produces enough DNA for 100–300 real-time PCR assays (e.g., using EpiTect MethyLight PCR Kits) or end-point PCRs (e.g., using EpiTect MSP Kits), estimating 10 ng of amplified DNA per reaction.

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Product category: Rapid tests - clinical chemistry

For high-throughput Hybrid Capture 2 (HC2) assays

•Streamlines digene HC2 High-Risk HPV and other HC2 DNA tests
•Significant increase in labor savings
•Decreases turn-around time for delivering results to physicians
•Enables the laboratory to increase testing capacity

The Rapid Capture System is a semi-automated pipetting and microplate handling system for high-volume sample-throughput testing. This system handles up to 352 specimens and 1 to 4 plates in a single 8 hour shift (competitive productivity comparison of 352 specimens, CT results only; data collected by third party consultants — on file). The Rapid Capture System fits on a standard bench top and is compatible with software that provides LIS interface connectivity.

Performance

The Rapid Capture System (RCS) is CE-IVD marked (see "IVD mark") for use with the digene HC2 High-Risk HPV DNA Test, digene HC2 HPV DNA Test, digene HC2 CT-ID DNA Test, and the digene HC2 GC-ID DNA Test. The system processes cervical samples collected in Specimen Transport Medium (STM), which is part of the digene Cervical Sampler, as well as ThinPrep PreservCyt Solution (Hologic) and BD SurePath Preservative Fluid. Other digene tests or sample types may be available for use on the RCS, depending on country regulations.

Onboard reagent stability

The RCS provides reagent stability of 16 hours for those reagents most likely to be subject to extended onboard placement — Probe Mix, Detection Reagent 1, Detection Reagent 2, and the Capture Plates.

Principle

The Rapid Capture System reduces repetitive manual steps, with technology that performs semi-automated assays. The system is designed to work with the Hybrid Capture 2 screening technology, and it is the only high-throughput system for testing cervical samples with the FDA-approved digene HC2 High-Risk HPV DNA Test. The Rapid Capture system provides the flexibility of multiple software scripts, allowing laboratories to adjust their schedules to improve workflow.

Specimen contamination or carryover of residual alkaline phophotase is minimized through the use of disposable pipet tips for reagent and specimen aspiration. The system automates sample transfers (from sample tubes to hybridization plate, then from hybridization plate to Capture Plate), plate handling, precision reagent pipetting with liquid level-sensing tips, incubation at ambient and 65°C temperatures, and washing.

Procedure

Multiple assays for flexible workflows

The Rapid Capture System (RCS) accommodates multiple assays or sample types during a single run — enabling scheduling flexibility. For instance, when running a single run of the digene HC2 High-Risk HPV DNA Test on the RCS, separate plates can handle both liquid based cytology (LBC) samples and digene cervical samples.

The Rapid Capture System can be used with the digene HC2 High-Risk HPV DNA Test, digene HC2 HPV DNA Test, digene HC2 CT-ID DNA test, and digene HC2 GC-ID DNA Test. Depending on the test, the specimens can be collected using the digene Cervical Sampler, Specimen Transport Medium (STM), digene Female Swab Specimen Collection Kit, PreservCyt solution, and SurePath Preservative Fluid.

High-throughput design for optimized workflow

The Rapid Capture System performs up to 352 tests/8 hours, automating 6 procedural steps of the manual method:
Specimen pipetting Regent dispensing Microplate handling Microplate mixing Microplate incubation Microplate washing
User intervention is limited to specimen preparation, loading of specimen racks onto the deck, deck setup, chemiluminescent signal detection, and result reporting. Denaturation of the specimens in preparation for testing with the digene HC2 DNA Tests is performed independently of the Rapid Capture System. In addition, amplified chemiluminescent signal detection and result reporting are performed using the offline DML 2000/3000 Instrument and using the digene Hybrid Capture System Version 2 (DHCS v.2) Software.

The Rapid Capture System is intended to be used only in combination with QIAGEN kits indicated for use with the Rapid Capture System for applications described in the kit handbooks.

Applications

A range of digene HC2 DNA tests enable high-throughput detection of pathogens using the Rapid Capture System. Using kits for Hybrid Capture applications, the Rapid Capture System automates detection of:
High-risk human papillomavirus (HPV) infection High-risk and low-risk HPV infections Chlamydia trachomatis (CT) infections Neisseria gonorrhoeae (GC) infections

Software

The HC2 System Software reports qualitative assay results with a user-friendly interface. Software supports customizable report formats — sorted by plate or specimen, with summary or detailed outputs. All results are tracked by the user ID for auditing and QA. The Rapid Capture System ScriptSelect Software allows users to choose the appropriate protocol and number of tests being run.

The HC2 System Software is compatible with multiple types of bar codes, which saves time and reduces manual entry errors. The software fully interfaces with Laboratory Information Systems (LIS), through which designated users can send patient and QC data to the laboratory network.

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Product category: Rapid tests - clinical chemistry

For the detection of PAMG-1 in amniotic fluid found in vaginal discharge of pregnant women

•A CE marked, FDA and CFDA cleared (10m US version) ROM immunoassay
•99% accurate with no gestational limit(1)
•99% correlated to known ROM Gold Standard (intra-amniotic injection of indigo carmine
•99% sensitive and 98% specific to support accuracy of negative and positive ROM clinical results

The AmniSure ROM (Rupture Of [fetal] Membranes) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women. The AmniSure ROM Test uses amniotic test strips to detect the PAMG-1 protein marker of the amniotic fluid in vaginal discharge. The amniotic fluid test is used by health care professionals to aid in the detection of ROM in pregnant women reporting signs, symptoms, or complaints suggestive of ROM.

Premature rupture of fetal membranes (PROM) occurs in about 10% of pregnancies and poses one of the most important therapeutic dilemmas in current obstetric practice(2). Management of patients with PROM and pPROM (pre-term PROM, occurring before 37 weeks gestation) is expensive and remains an important perinatal dilemma as the clinician attempts to balance the risk of prolonging gestation against the risks of infection(2).

Risks of PROM at term are related to serious neonatal consequences such as pre-term delivery, fetal distress, prolapsed cord, abruptio placentae and infection(2). pPROM accounts for 20% to 40% of PROM cases, and is associated with 20% to 50% of premature births. Complications of pPROM include infectious morbidity in the mother and fetus, pulmonary hypoplasia of the fetus, prolapse of the umbilical cord, development of fetal deformities, and postnatal endometritis(2). All of these consequences significantly increase risk of fetal and maternal morbidity and mortality.

The AmniSure ROM Test kit is a self-contained system that serves as an aid to rapidly and accurately diagnosis PROM, which is crucial to ensure appropriate obstetric measures are taken in the event of a rupture. Failure to identify patients with ROM can result in the failure to intervene appropriately.

Conversely, the false diagnosis of ROM can lead to inappropriate interventions (e.g., hospitalization or induction of labor). Therefore the correct and timely diagnosis of ROM is of crucial importance for the clinician(2). Accurate diagnosis of [fetal] membranes rupture, however, remains a frequent clinical problem in obstetrics(2-4).
Other available tests have limitations or are in some degree invasive(2). The AmniSure ROM Test is a rapid, non-invasive, amniotic fluid test that can aid in the detection of ROM, providing rapid, easy-to-interpret and timely results. As an alternative to conventional methods of ROM detection, the AmniSure test has a 99% sensitivity and 98% specificity to support accuracy of negative and positive ROM clinical results.

Principle

The AmniSure ROM Test uses the principles of immunochromatography to detect human PAMG-1 protein present in amniotic fluid. The test employs highly sensitive monoclonal antibodies that detect even a minimal amount of PAMG-1, which is present in cervicovaginal discharge after rupture of fetal membranes. PAMG-1 was selected as a marker of fetal membranes rupture due to its high level in amniotic fluid, low level in blood, and extremely low background level in cervicovaginal discharge when fetal membranes are intact. To minimize the frequency of false results, two monoclonal antibodies were selected to set the sensitivity threshold of the AmniSure ROM Test at the optimal low level of 5 ng/ ml.The maximum background concentration of PAMG-1 in cervicovaginal discharge is slightly lower than the sensitivity cut-off of the AmniSure ROM Test, reducing false results and allowing for ~99% accuracy(2). A sample of cervicovaginal discharge (collected by vaginal swab) is placed into a vial with solvent for extraction. PAMG-1 is then detected in the sample through an amniotic fluid test strip (lateral flow device). The result is read visually by the presence of one or two lines in the test region of the strip.

Procedure

The simple 4-step test procedure* detects placental alpha microglobulin-1 (PAMG-1) a protein found in high concentrations in amniotic fluid and low concentration in cervicovaginal fluid (4).
1.Collect sample of vaginal discharge with sterile collection swab (no speculum required).
2.Rinse specimen swab in solvent vial. Discard swab.
3.Insert amniotic fluid test strip into vial and remove if 2 lines are visible, or at 5 minutes sharp.
4.Results are observed and recorded.

*Please refer to package insert for complete instructions for use.

Applications

The AmniSure test is for use by healthcare professionals to aid in the detection of fetal membranes rupture in pregnant women when they report signs, symptoms, or complaints suggestive of such a rupture. AmniSure should be used in appropriate sites by qualified personnel (physicians, certified nurse-midwives, or labor and delivery nurses certified to evaluate ROM). AmniSure can therefore be used in a variety of settings, from OB/GYN clinics and doctors’ offices, to outpatient clinics and labor admitting rooms.

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Product category: Rapid tests - clinical chemistry

For the detection of PAMG-1 in amniotic fluid found in vaginal discharge of pregnant women

•A CE marked, FDA and CFDA cleared (10m US version) ROM immunoassay
•99% accurate with no gestational limit(1)
•99% correlated to known ROM Gold Standard (intra-amniotic injection of indigo carmine
•99% sensitive and 98% specific to support accuracy of negative and positive ROM clinical results

The AmniSure ROM (Rupture Of [fetal] Membranes) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women. The AmniSure ROM Test uses amniotic test strips to detect the PAMG-1 protein marker of the amniotic fluid in vaginal discharge. The amniotic fluid test is used by health care professionals to aid in the detection of ROM in pregnant women reporting signs, symptoms, or complaints suggestive of ROM.

Premature rupture of fetal membranes (PROM) occurs in about 10% of pregnancies and poses one of the most important therapeutic dilemmas in current obstetric practice(2). Management of patients with PROM and pPROM (pre-term PROM, occurring before 37 weeks gestation) is expensive and remains an important perinatal dilemma as the clinician attempts to balance the risk of prolonging gestation against the risks of infection(2).

Risks of PROM at term are related to serious neonatal consequences such as pre-term delivery, fetal distress, prolapsed cord, abruptio placentae and infection(2). pPROM accounts for 20% to 40% of PROM cases, and is associated with 20% to 50% of premature births. Complications of pPROM include infectious morbidity in the mother and fetus, pulmonary hypoplasia of the fetus, prolapse of the umbilical cord, development of fetal deformities, and postnatal endometritis(2). All of these consequences significantly increase risk of fetal and maternal morbidity and mortality.

The AmniSure ROM Test kit is a self-contained system that serves as an aid to rapidly and accurately diagnosis PROM, which is crucial to ensure appropriate obstetric measures are taken in the event of a rupture. Failure to identify patients with ROM can result in the failure to intervene appropriately.

Conversely, the false diagnosis of ROM can lead to inappropriate interventions (e.g., hospitalization or induction of labor). Therefore the correct and timely diagnosis of ROM is of crucial importance for the clinician(2). Accurate diagnosis of [fetal] membranes rupture, however, remains a frequent clinical problem in obstetrics(2-4).
Other available tests have limitations or are in some degree invasive(2). The AmniSure ROM Test is a rapid, non-invasive, amniotic fluid test that can aid in the detection of ROM, providing rapid, easy-to-interpret and timely results. As an alternative to conventional methods of ROM detection, the AmniSure test has a 99% sensitivity and 98% specificity to support accuracy of negative and positive ROM clinical results.

Principle

The AmniSure ROM Test uses the principles of immunochromatography to detect human PAMG-1 protein present in amniotic fluid. The test employs highly sensitive monoclonal antibodies that detect even a minimal amount of PAMG-1, which is present in cervicovaginal discharge after rupture of fetal membranes. PAMG-1 was selected as a marker of fetal membranes rupture due to its high level in amniotic fluid, low level in blood, and extremely low background level in cervicovaginal discharge when fetal membranes are intact. To minimize the frequency of false results, two monoclonal antibodies were selected to set the sensitivity threshold of the AmniSure ROM Test at the optimal low level of 5 ng/ ml.The maximum background concentration of PAMG-1 in cervicovaginal discharge is slightly lower than the sensitivity cut-off of the AmniSure ROM Test, reducing false results and allowing for ~99% accuracy(2). A sample of cervicovaginal discharge (collected by vaginal swab) is placed into a vial with solvent for extraction. PAMG-1 is then detected in the sample through an amniotic fluid test strip (lateral flow device). The result is read visually by the presence of one or two lines in the test region of the strip.

Procedure

The simple 4-step test procedure* detects placental alpha microglobulin-1 (PAMG-1) a protein found in high concentrations in amniotic fluid and low concentration in cervicovaginal fluid (4).
1.Collect sample of vaginal discharge with sterile collection swab (no speculum required).
2.Rinse specimen swab in solvent vial. Discard swab.
3.Insert amniotic fluid test strip into vial and remove if 2 lines are visible, or at 5 minutes sharp.
4.Results are observed and recorded.

*Please refer to package insert for complete instructions for use.

Applications

The AmniSure test is for use by healthcare professionals to aid in the detection of fetal membranes rupture in pregnant women when they report signs, symptoms, or complaints suggestive of such a rupture. AmniSure should be used in appropriate sites by qualified personnel (physicians, certified nurse-midwives, or labor and delivery nurses certified to evaluate ROM). AmniSure can therefore be used in a variety of settings, from OB/GYN clinics and doctors’ offices, to outpatient clinics and labor admitting rooms.

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About us

Company details

Smart Optical Devices
QIAGEN Lake Constance developes and produces innovative, optical measurement devices for medical-, environmental- and industrial applications. Our compact and high performance detector technology for fluorescence and UV measurement is the perfect solution for on-site measurement. We provide mobile battery powered handheld devices as well as online measurement systems integrated into fully automated processes.

Unique Fluorescence Technology
QIAGEN Lake Constance's novel fluorescence technology encompasses the requirements for mobile high performance handheld devices in medical applications as well as online measurement in automated processes. Main features are: Small size, high sensitivity, reliability and robustness, low costs, ease of use and rapid customisability for new applications. It allows measurement on surfaces an in liquids and in the presence of ambient light.

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Company data

Sales volume

10-49 Mio US $

Export content

max. 25%

Number of employees

50-99

Foundation

1997

Area of business

Electromedical equipment / Medical Technology