QIAGEN

Rupture of Fetal Membranes Test
AmniSure ROM Test

The AmniSure ROM Test (Rupture of [fetal] Membranes test) is intended for the detection of PAMG-1 in amniotic fluid found in the vaginal discharge of pregnant women. It uses amniotic fluid test strips to detect the PAMG-1 protein marker of the amniotic fluid in vaginal discharge and is used by health care professionals to aid in the detection of ROM in pregnant women reporting signs, symptoms, or complaints suggestive of ROM.

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Human Cytomegalovirus (CMV) DNA Test
artus CMV QS-RGQ MDx Kit

The artus CMV QS-RGQ MDx Kit is intended for the detection and quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma. The test is intended for use as an aid in the management of solid organ transplant patients who are undergoing anti-CMV therapy and can be used to assess CMV viral load response to antiviral drug therapy.

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RT-PCR Enzymes and Kits
QuantiNova Pathogen +IC Kit

The QuantiNova Pathogen +IC Kit is designed for sensitive, rapid real-time (RT)-PCR detection of pathogen nucleic acids using sequence-specific probes. The kit contains reagents for 4-plex real-time detection of user-defined pathogen targets (e.g., virus, bacteria, fungi, etc.) plus the QuantiNova Internal Control (IC) RNA or DNA. Both ICs and assay are included for use as extraction or amplification controls, allowing correct interpretation of negative detection results.

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DNA and RNA Purification Kit
QIAampMinElute Virus Kits

QIAamp MinElute Virus Kits simplify viral DNA and RNA purification with fast spin-column and vacuum procedures. The kits use starting sample volumes of up to 0.2 ml and combine the selective binding properties of a silica-based membrane with flexible elution volumes of between 20 and 150 μl. The QIAamp MinElute Virus Spin process can be fully automated on the QIAcube Connect.

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High Capacity Syndromic Testing Platform
QIAstat-Dx Rise

The QIAstat-Dx Rise is a high-capacity version of the QIAstat-Dx automated syndromic system with enhancements to the menu of tests for a fully integrated one-step molecular testing solution that provides results in about one hour. With a random access capacity of up to 18 different tests, it can provide diagnostic results for up to 56 tests in an eight-hour shift and 160 tests per day by using eight analytical modules.

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Digital PCR System
QIAcuity

The QIAcuity Digital PCR System is designed to deliver precise and multiplexed quantification results for mutation detection, copy number variation (CNV), gene expression studies, gene-editing analysis, and many more. The nanoplate-based system seamlessly integrates a standard dPCR workflow of partitioning, thermocycling and imaging into a walk-away automated platform with minimal hands-on time.

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Tuberculosis (TB) Test
QIAreach QuantiFERON-TB

The QIAreach QuantiFERON-TB is a portable device that enables the ultrasensitive digital detection of TB infection with an end-to-end workflow that is simple and cost efficient, and increases access to reliable Interferon Gamma Release Assay (IGRA) testing. Built on the proven QuantiFERON-TB Gold Plus technology, it uses blood samples to test for interferon-gamma molecules released from T-cells that have come into contact with TB bacteria. QIAreach QuantiFERON-TB runs these tests on the digital eHub and eStick system, a true walkaway solution with random access and no calibration or maintenance. QIAreach QuantiFERON TB testing requires one patient visit and produces an easy-to-read result in 20 minutes after sample incubation, with the ability to record and send results for improved data management, making it ideal for TB screening programs.

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Modular Syndromic Testing System
QIAstat-Dx (DiagCORE) Analyzer

The QIAstat-Dx (DiagCORE) Analyzer is a modular and scalable system designed to work in any clinical setting. The system runs application cartridges on demand from predefined assay protocols, via displayed step-by-step instructions, offering an intuitive and safe user experience. The QIAstat-Dx Analyzer and cartridges are designed as a closed system that contains on board all necessary reagents, enabling hands-off sample preparation.

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Gastrointestinal Panel
QIAstat-Dx Gastrointestinal Panel

The QIAstat-Dx Gastrointestinal Panel utilizes proven QIAGEN sample and assay technologies to provide clinical insights for patients with suspected gastrointestinal infections. It can accept liquid transport medium (200 µl), and detect 24 viral and bacterial pathogens in about an hour with less than one minute hands-on time.

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Respiratory Panel
QIAstat-Dx (DiagCORE) Respiratory Panel V2

The QIAstat-Dx (DiagCORE) Respiratory Panel V2 utilizes proven QIAGEN sample and assay technologies to provide clinical insights for patients with suspected upper respiratory infections. It can accept both direct swabs and liquid transport medium (300 µl), and detect 21 viral and bacterial pathogens in about an hour with less than one minute hands-on time.

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SARS-CoV-2 RUO Solution
QuantiFERON SARS-CoV-2 RUO

The QuantiFERON SARS-CoV-2 RUO solution is an original combination of blood collection tubes containing innovative specific peptides formulated to stimulate lymphocytes in heparinized whole blood involved in cell-mediated immunity. Plasma from the stimulated samples can then be used for detection of IFN-γ using a simple ELISA. The QuantiFERON SARS-CoV-2 RUO solution is composed of several components that can be ordered separately or combined to provide better research insights on patients’ immune status.

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SARS-CoV-2 Antigen Testing Device
QIAreach eHub

The QIAreach eHub portable SARS-CoV-2 antigen testing device, in combination with QIAreach assay eSticks, provides a simplified workflow for multiple in vitro diagnostic tests, using state-of-the-art nanoparticle fluorescence detection technology. QIAreach assay eSticks are single-use tests that include a lateral flow strip and optoelectronics that perform test measurements and interpret results. The QIAreach eHub provides power to the QIAreach test eStick to run the test when the test eStick is connected to any one of the eHub eStick ports. The QIAreach eHub visually communicates test progress and results to the user via a display screen specific to each eHub port.

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SARS-CoV-2 Primer Panel
QIAseq SARS-CoV-2 Primer Panel

The QIAseq SARS-CoV-2 Primer Panel combines both reverse transcription and whole genome enrichment of the viral RNA for targeting SARS-CoV-2 to generate amplicons for downstream library creation. When paired with a QIAseq FX DNA Library UDI Kit, sequencing-ready libraries compatible with Illumina platforms can be constructed. QIAseq SARS-CoV-2 primer pools utilize designs from the ARTIC V3 primers which have also gone through an in silico check to reduce chances for dimerization during sample enrichment.

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Viral RNA UM Kit
QIAprep& Viral RNA UM Kit

The QIAprep& Viral RNA UM Kit combines a liquid-based sample preparation step completed in only two minutes with real-time RT-PCR detection in a streamlined workflow. Users can automate this method with standard lab equipment for any throughput, assay and reaction need from single to multiplex testing. The kit is compatible with dual-labeled probes, e.g., TaqMan probes in multiplex one-step RT-PCR detection of one or more targets (altogether, up to 4 assays including the internal controls).

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Respiratory SARS-CoV-2 Panel
QIAstat-Dx Respiratory SARS-CoV-2 Panel

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplex syndromic cartridge that detects and differentiates 21 respiratory targets, including SARS-CoV-2 from nasopharyngeal swabs (NPS) eluted in universal transport media (UTM). It offers an intuitive workflow with less than one-minute hands-on time and provides comprehensive qualitative results in about an hour.

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SARS-CoV-2 Antibody Test
QIAreach Anti-SARS-CoV-2 Total Test

The QIAreach Anti-SARS-CoV-2 Total Test is a rapid, digital lateral flow serological test, using nanoparticle fluorescence, intended for qualitative detection of total antibodies to SARS-CoV-2 in human serum and plasma (heparin, EDTA). It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

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SARS-CoV-2 Antigen Test
QIAreach SARS-CoV-2 Antigen Test

The QIAreach SARS-CoV-2 Antigen Test is a scalable, digital assay for the in vitro detection of the SARS-CoV-2 nucleocapsid protein antigen that allows testing up to eight patients simultaneously for SARS-CoV-2 infection with the first positive results in just two minutes. As part of the complete QIAreach solution for SARS-CoV-2 testing, the test will run simultaneously with the QIAreach Anti-SARS-CoV-2 Total Test on a single QIAreach eHub.

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Molecular System
NeuMoDx 288

The NeuMoDx 288 Molecular System is designed for the automated extraction and isolation of nucleic acids, as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR. Consisting of the instrument with touchscreen computer, accessories, and reagents and consumables, the instrument is intended for in vitro diagnostic (IVD) use in performing NeuMoDx-validated nucleic acid testing in clinical laboratories.

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Molecular System
NeuMoDx 96

The NeuMoDx 96 Molecular System is designed for the automated extraction and isolation of nucleic acids, as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR. Consisting of the instrument with touchscreen computer, accessories, and reagents and consumables, the system is intended for in vitro diagnostic (IVD) use in performing NeuMoDx-validated nucleic acid testing in clinical laboratories.

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SARS-CoV-2 Assay
NeuMoDx SARS-CoV-2 Assay

The NeuMoDx SARS-CoV-2 Assay is a real-time RT-PCR diagnostic test intended for the qualitative detection of SARS-CoV-2 coronavirus RNA in nasal, nasopharyngeal and oropharyngeal swabs in transport medium, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. This test is performed on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems and is also for use with saliva specimens that are collected within a healthcare setting by individuals using the NeuMoDx Saliva Collection Kit when determined to be appropriate by a healthcare provider.

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Flu A/SARS-CoV-2 Test
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test

The NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test is a multiplex polymerase chain reaction (PCR) test that detects and differentiates influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes. The respiratory test takes advantage of the NeuMoDx 96 and NeuMoDx 288 molecular systems’ automated three-step workflow and has obtained CE-IVD approval for the use of saliva samples collected with the NeuMoDx Saliva Collection Kit, which includes a collection vial, stabilization tube and pipette.

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KRAS PCR Assay
therascreen KRAS RGQ PCR Kit

The therascreen KRAS RGQ PCR Kit is an FDA-approved, qualitative real-time PCR assay for the detection of specific mutations in the KRAS oncogene. The kit provides reagents optimized for rapid and sensitive detection of seven somatic mutations using the Rotor-Gene Q MDx instrument.

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PCR Assay
ipsogen JAK2 RGQ PCR Kit

The ipsogen JAK2 RGQ PCR Kit is a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. The test is a real-time PCR assay performed on the QIAGEN Rotor-Gene Q MDx (US) instrument and is intended for use as an adjunct to the evaluation of suspected myeloproliferative neoplasms (MPNs), in conjunction with other clinicopathological factors.

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PIK3CA Test
PIK3CA RGQ PCR Kit

The PIK3CA RGQ PCR Kit is the first FDA-approved companion diagnostic (CDx) test to identify patients with advanced breast cancer for whom treatment with the ∝-selective PI3K-inhibitor PIQRAY (alpelisib) may be appropriate. The unique molecular test is based on the detection of specific PIK3CA mutations in tumor DNA isolated from either FFPE tumor tissue or plasma samples.

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In Vitro Diagnostic Test
QuantiFERON-TB Gold (QFT) Kit

The QuantiFERON-TB Gold (QFT) Kit is an in vitro diagnostic test that aids in the detection of M. tuberculosis infection. QFT is an interferon γ (IFNγ) release assay (IGRA) which measures the cell-mediated response to specific TB antigens in whole blood.

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Nucleic Acid Amplification & Detection System
Rotor-Gene Q MDx

The Rotor-Gene Q MDx enables high-precision IVD-validated real-time PCR analysis and offers outstanding thermal and optical performance due to its rotary format. Used in combination with QIAGEN’s broad portfolio of CE-IVD-marked PCR kits, it is highly suited for in vitro diagnostic applications.

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DNA/RNA Analysis System
QIAxcel Advanced

The QIAxcel Advanced System fully automates sensitive, high-resolution capillary electrophoresis of up to 96 samples per run and allows DNA fragment analysis of 12 samples to be performed in three minutes. It utilizes ready-to-run gel cartridges, which allow 96 samples to be analyzed with a minimum of hands-on interaction, thus reducing manual handling errors and eliminating the need for tedious gel preparation.

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