QIAGEN

Nucleic Acid Purification Instrument
QIAsymphony Connect

The QIAsymphony Connect is a fully automated nucleic acid purification system designed to process up to 96 samples using cartridge-based reagent kits and magnetic particle technology. It automates lysis, binding, washing, and elution to reduce hands-on time and improve run-to-run consistency across a wide range of sample types, including low-input and challenging clinical materials. Built-in barcode tracking, inventory management, LIMS and QIAsphere connectivity, and software-controlled workflows support end-to-end traceability, while optimized bead collection and elution help maximize nucleic acid recovery for sensitive downstream applications such as dPCR, NGS, liquid biopsy, and precision oncology.

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Gram Negative AMR Panel
QIAstat-Dx BCID GN Plus AMR Panel

The QIAstat-Dx BCID GN Plus AMR Panel is a cartridge-based qualitative in vitro diagnostic test for use on the QIAstat-Dx system to support rapid identification of Gram-negative bloodstream infections. The panel analyzes 13 common Gram-negative bacterial targets and 18 antimicrobial resistance markers to support treatment decisions. It is intended for use in patients with gram-negative bacterial infections identified as such via Gram stain from positive blood culture* or pure colony samples.

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AMR Panel
QIAstat-Dx BCID GPF Plus AMR Panel

The QIAstat-Dx BCID GPF Plus AMR Panel is a cartridge-based in vitro diagnostic test for use on the QIAstat-Dx system to help identify bloodstream infections from positive blood culture samples. Each kit includes six individually packaged cartridges with reagents for sample preparation, multiplex real-time PCR, internal control, and transfer pipettes. The panel detects 20 gram-positive bacterial and fungal pathogens, includes a broad pan gram-negative target, and identifies 10 genetic antimicrobial resistance markers. With results in about one hour, it integrates sample preparation, PCR testing, and data analysis into a streamlined workflow that reduces hands-on time and supports clear result interpretation.

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Modular Syndromic Testing System
QIAstat-Dx Analyzer 2.0

The QIAstat-Dx system is a cartridge-based molecular diagnostics platform designed to simplify infectious disease testing with fast, syndromic results. Using multiplex real-time PCR, QIAstat-Dx assay cartridges detect multiple pathogen nucleic acids from a single patient sample in about an hour, with preloaded reagents and automated sample processing. The Analyzer 2.0 adds remote result review, notifications, software updates, and QIAstat-Dx connectivity powered by QIAsphere. Together, the system supports rapid diagnosis, collaboration, surveillance, and efficient laboratory workflows.

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mRNA Extraction Kits
TurboCapture mRNA Kits

The TurboCapture mRNA Kits provide an efficient, high-throughput method for mRNA extraction using unique oligonucleotide immobilization technology. This plate-based system allows for easy mRNA purification and cDNA synthesis in a single well, streamlining the process for large-scale studies. The TurboCapture system minimizes protocol steps and hands-on time, making it an ideal solution for RNA research applications. It is compatible with robotic workstations, ensuring seamless integration into automated workflows.

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Human Papillomavirus Test
digene HC2 HPV DNA Test

The digene HC2 HPV DNA Test is an in vitro microplate assay based on signal-amplified nucleic acid hybridization that uses chemiluminescence for the qualitative detection of 18 types of human papillomavirus (HPV) DNA in cervical specimens. The test uses Hybrid Capture 2 technology to detect high-risk and low-risk HPV genotypes.

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Avapritinib Companion Diagnostic Test
therascreen PDGFRA RGQ PCR Kit

The therascreen PDGFRA RGQ PCR Kit is a real-time qualitative in vitro diagnostic assay for the detection of the D842V somatic mutation in the PDGFRA gene using genomic DNA extracted from gastrointestinal stromal tumor (GIST) patient’s formalin-fixed, paraffin-embedded (FFPE) tumor tissue. The kit is intended to aid clinicians in identifying patients with GIST who may be eligible for treatment with AYVAKIT (avapritinib) based on a PDGFRA mutation-detected result.

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Microfluidic Digital PCR Plates
QIAcuityDx Nanoplates

QIAcuityDx Nanoplates are microfluidic digital PCR plates designed for high-throughput applications, enabling 24 or 96 samples to be processed with up to 26,000 partitions per well. These plates are compatible with QIAcuityDx instruments, allowing for precise digital PCR reactions. With a simple, plate-based format, they streamline the workflow for high-sensitivity quantification, ensuring reliable results in research and diagnostic applications. These nanoplates are ideal for life science configurations requiring varying partition numbers.

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Fecal DNA Extraction Kit
QIAamp PowerFecal Pro DNA Kit

The QIAamp PowerFecal Pro DNA Kit is optimized for isolating high-yield microbial DNA from stool and gut samples. Utilizing enhanced bead tube technology and improved lysis chemistry, it enables efficient breakdown of bacterial and fungal cells. Streamlined inhibitor removal allows for rapid recovery of DNA suitable for next-generation sequencing. The kit delivers up to 20x more DNA than traditional methods and supports automation on the QIAcube Connect for high-throughput workflows.

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DNA Tissue Kit
EZ1&2 DNA Tissue Kit

The EZ1&2 DNA Tissue Kit facilitates automated purification of DNA from up to 40 mg of tissue using magnetic-particle technology. Compatible with EZ1 Advanced XL and EZ2 Connect systems, it processes 1–24 samples per run. Prefilled, sealed reagent cartridges streamline handling and reduce contamination risks. The kit delivers up to 28 µg of high-quality DNA from various sample types including blood, buccal cells, and FFPE tissue, supporting standardized, scalable genomic workflows.

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Blood RNA Extraction Kit
QIAamp RNA Blood Mini Kit

The QIAamp RNA Blood Mini Kit offers rapid, silica-membrane-based purification of cellular RNA from up to 1.5 mL of whole blood. Stabilized with EDTA, citrate, or heparin, the samples undergo homogenization via the QIAshredder column. This streamlined protocol provides high yields without requiring organic extraction or alcohol precipitation. Suitable for use on the QIAcube Connect, this kit ensures consistent and ready-to-use RNA ideal for gene expression and other molecular biology applications.

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RNA Purification Kit
RNeasy Mini Kit

The RNeasy Mini Kit enables fast and efficient purification of high-quality total RNA from a wide range of sample types including cells, tissues, and yeast. Using silica-membrane spin columns, the kit eliminates the need for phenol-chloroform extraction or ethanol precipitation. It delivers consistent yields of RNA suitable for any downstream application. The kit supports high-throughput processing in a 96-well format and can be automated on the QIAcube Connect for scalable sample preparation.

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RNA Isolation Kits
RNeasy Plus Kits for RNA Isolation

The RNeasy Plus Kits for RNA Isolation are high-quality kits designed to provide efficient and reliable isolation of high-purity RNA from a wide range of sample types, including tissues, cells, and blood. These kits utilize advanced silica-membrane technology, ensuring rapid and consistent RNA extraction while minimizing genomic DNA contamination. The RNeasy Plus Kits also feature a built-in DNA elimination step, further enhancing RNA purity.

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Collection Tube
PAXgene Blood DNA Tube (IVD)

The PAXgene Blood DNA Tube (IVD) is a specialized collection tube designed for the stabilization and preservation of DNA from whole blood samples. It prevents DNA degradation during sample transport and storage, ensuring high-quality DNA for downstream applications such as PCR, sequencing, and genetic analysis. The tube is intended for in vitro diagnostic (IVD) use, offering consistent and reliable results for clinical and research laboratories.

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DSP Virus Spin Kit
QIAamp DSP Virus Spin Kit

The QIAamp DSP Virus Spin Kit is a high-performance tool designed for the efficient extraction of viral nucleic acids from a variety of sample types, including plasma, serum, and other biological fluids. Utilizing advanced spin-column technology, this kit ensures high-quality, purified viral RNA or DNA, making it ideal for accurate molecular diagnostics. The kit is optimized for fast and reliable virus isolation, enabling the detection and identification of a wide range of viral pathogens.

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RNA/DNA Extraction Instrument
QIAcube Connect Instrument

The QIAcube Connect automates spin-column-based nucleic acid extractions for up to 12 samples per run. With over 140 standard protocols and optional customization, it ensures reproducibility, efficiency, and remote monitoring via the QIAsphere app.

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SISTEMA AUTOMÁTICO DE PURIFICACIÓN DE ÁCIDOS NUCLEICOS
QIAcube HT

El QIAcube HT proporciona una purificación de ácidos nucleicos de rendimiento medio a alto en un formato de 96 pocillos. Compatible con diversos tipos de muestras, automatiza los protocolos de extracción de ADN, ARN y miARN.

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DNA Blood Mini Kit
QIAamp DSP DNA Blood Mini Kit

The QIAamp DSP DNA Blood Mini Kit uses silica-based technology for the purification of genomic DNA from blood. It supports automated workflows with QIAcube Connect MDx, ensuring reliable results for in vitro diagnostic labs processing blood samples.

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Circulating DNA Kit
QIAsymphony DSP Circulating DNA Kit

The QIAsymphony DSP Circulating DNA Kit automates the purification of circulating cell-free DNA from plasma or urine using the QIAsymphony SP instrument. It processes 1–10mL sample volumes with high efficiency, supporting clinical diagnostics and research applications.

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Clinical Sample Concentrator
QIAamp DSP Virus Kit

The QIAamp DSP Virus Kit is intended for the purification of viral nucleic acids from human plasma and serum for in vitro diagnostic use. It uses well-established and convenient QIAamp technology for the simultaneous purification of viral DNA and RNA. Viral nucleic acids purified using the QIAamp DSP Virus Kit are ready to use in sensitive downstream applications, such as those based on enzymatic amplification, including PCR and RT-PCR.

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RNA Isolation/Purification Tissue
RNeasy DSP FFPE Kit

The RNeasy DSP FFPE Kit is specially designed for the purification of total RNA from formalin-fixed paraffin-embedded (FFPE) tissue sections for in vitro diagnostic use. It efficiently removes formalin crosslinking and releases RNA without compromising RNA integrity.

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SISTEMA DE PCR DIGITAL
QIAcuityDx

QIAcuityDx es un sistema de PCR digital de sobremesa con un solo punto de contacto que integra perfectamente la partición/procesamiento, la PCR y el análisis. Realiza un procesamiento totalmente automatizado de las nanoplacas QIAcuityDx.

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Automated Nucleic Acid Extraction Instrument
EZ2 Connect MDx

The EZ2 Connect MDx is a compact benchtop instrument for the automated isolation of nucleic acids from up to 24 samples in parallel, using sealed prefilled cartridges. Designed for fast automated nucleic acid extraction in IVD workflows, this IVD benchtop instrument automatically pierces the sealed cartridges, heats samples for incubation, and automates the pipetting of beads, buffers, and even enzymes.

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TERMOCICLADOR DE PCR EN TIEMPO REAL
QIAquant

QIAquant es un termociclador de PCR en tiempo real de alto rendimiento con un sistema de detección 2plex y un bloque de 96 pocillos. Combina la detección óptica de productos qPCR con un bloque térmico de alto rendimiento.

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Real-Time RT-PCR Kits
QuantiNova RT-PCR Kits

QuantiNova RT-PCR Kits (real-time RT-PCR kits) is intended for the highly sensitive and specific one-step qRT-PCR and multiplex qRT-PCR using sequence-specific probes or one-step qPCR using SYBR® Green I for gene expression analysis. The kits enable sensitive quantification of RNA targets by real-time one-step PCR using SYBR Green I or sequence-specific probes.

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Blood RNA Kit
PAXgene Blood RNA Kit

The PAXgene Blood RNA Kit is intended for the isolation and purification of intracellular RNA from blood stabilized in PAXgene Blood RNA Tubes. The PAXgene Blood RNA system consists of PAXgene Blood RNA Tubes for blood collection, stabilization, and transport, and the PAXgene Blood RNA Kit for silica-membrane-based RNA isolation and purification in a spin-column format.

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Nucleic Acid Purification Kit
EZ1 DSP Virus Kit

The EZ1 DSP Virus Kit is intended for the automated purification of DNA from 1–24 or 1–14 human biological specimens using the EZ2 Connect MDx or the EZ1 Advanced XL and provides exact performance specifications, assuring highly reliable viral nucleic acid purification. The kit contains all the required reagents and labware for automated purification of viral nucleic acids and bacterial DNA from human serum, plasma, cerebrospinal fluid (CSF), stool and nasopharyngeal swabs in UTM using magnetic-particle technology.

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DNA Blood Kits
EZ1&2 DNA Blood Kits

EZ1&2 DNA Blood Kits contain all required reagents and labware for rapid, automated purification of DNA from 200-350 μl whole blood samples or buffy coat samples using magnetic-particle technology. The reagents are supplied in prefilled and sealed reagent cartridges, ensuring speed and convenience in loading the instrument.

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HPV Test
careHPV Test

QIAGEN’s careHPV Test allows testing for high-risk HPV in limited resource settings and can be used for primary, stand-alone screening in women 30 years and older to determine high-risk HPV infection, which is a risk factor for developing cervical cancer. It can be run by a healthcare worker with proper training and without formal laboratory skills and may be run on electricity or a battery with an inverter, making it portable and adaptable.

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HPV PCR Test
QIAscreen HPV PCR Test

The QIAscreen HPV PCR Test is an in vitro real-time PCR-based assay for the qualitative detection of human papillomavirus (HPV) DNA of 15 (likely) (1) high-risk HPV genotypes. The test is part of QIAGEN’s family of PCR-based women’s health tests on the Rotor-Gene Q instrument, which includes tests for C. trachomatis, N. gonorrhoeae, and T. vaginalis.

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Virus/Pathogen Kits
QIAsymphony DSP

QIAsymphony DSP virus/pathogen kits, in combination with the QIAsymphony SP, enable automated purification of viral nucleic acids and bacterial DNA from a broad range of sample materials for in vitro diagnostic use. Optimized protocols provide high yields of pure nucleic acids, and flexible elution volumes allow nucleic acid concentration to be easily optimized for each downstream application. Novel, prefilled reagent cartridges reduce setup time and minimize manual handling while bar code reading enables full tracking of reagents.

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Nucleic Acid Purification Instrument
EZ1 Advanced XL

The EZ1 Advanced XL performs automated nucleic acid purification for a wide range of sample types relevant to molecular diagnostics, human identity testing, forensics, biomedical research, and gene expression analysis. Its ease of use enables fast and reproducible purification, without the need for specialized training or previous experience with laboratory automation.

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Automated Nucleic Acid Extractor
QIAcube Connect MDx

The QIAcube Connect MDx nucleic acid extractor is designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the system.

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Nucleic Acid Purification Instrument
QIAsymphony AS

The QIAsymphony AS nucleic acid purification instrument is designed to perform automated assay setup in molecular diagnostic and/or molecular biology applications. It is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the instrument.

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HPV Detection Test
Hybrid Capture 2

The Hybrid Capture 2 Modular System is for use with Hybrid Capture 2 (HC2) technology, such as the digene HC2 High-Risk HPV DNA Test, digene HC2 CT-ID DNA Test, and digene HC2 GC-ID DNA Test. The system processes specimens collected in Specimen Transport Medium (STM), which is part of the digene Cervical Sampler.

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Luminometer
DML 3000

The DML 3000 is a luminometer that automates amplified chemiluminescent signal detection and results reporting for HC2 assays, including the digene HC2 High-Risk HPV DNA Test. The benchtop, computer-controlled instrument measures light in the visible spectrum (300–650 nm) and measures chemiluninescence from opaque microplates.

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CT/GC Test
digene HC2 CT/GC DNA Test

The digene HC2CT/GC DNA Test is an in vitro nucleic microplate assay based on signal-amplified nucleic acid hybridization that uses chemiluminescence for the combined qualitative detection of DNA from Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) from cervical specimens. The kit is for labs that perform in vitro diagnostic tests and is meant to be used as an initial test to identify symptomatic or asymptomatic women with CT and/or GC infection.

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HPV Test
digene HC2 High-Risk HPV DNA Test

The digene HC2 High-Risk HPV DNA Test is an in vitro nucleic acid hybridization assay with signal amplification and chemiluminescence for the qualitative detection of 13 types of human papillomavirus (HPV) in cervical specimens. The test is suitable for high- or low-volume testing and is FDA-approved for in vitro diagnostic use.

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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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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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PANEL RESPIRATORIO SARS-COV-2
QIAstat-Dx Respiratory SARS-CoV-2 Panel

El panel QIAstat-Dx Respiratory SARS-CoV-2 es un cartucho sindrómico multiplex que detecta y diferencia 21 objetivos respiratorios, incluido el SARS-CoV-2 de hisopos nasofaríngeos (NPS) eluídos en medios de transporte universal (MTU).

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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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ENSAYO DE PCR
ipsogen JAK2 RGQ PCR Kit

El Kit ipsogen JAK2 RGQ PCR, es para la detección del alelo JAK2 V617F/G1849T en el ADN genómico extraído de sangre total con EDTA. El ensayo RT-PCR se realiza en el instrumento Rotor-Gene Q MDx.

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PRUEBA PIK3CA
PIK3CA RGQ PCR Kit

El kit PIK3CA RGQ PCR es la primera prueba diagnóstica complementaria aprobada por la FDA para identificar pacientes con cáncer de mama avanzado. La prueba se basa en la detección de mutaciones específicas de PIK3CA en el ADN tumoral.

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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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