DiaSorin Inc.

Panels and single-analyte immunoassays for infectious-disease testing (e.g., urinary antigen), gastrointestinal biomarkers (e.g., calprotectin), and other clinical analytes.

Multiplex nucleic acid testing panel for gastrointestinal pathogens.

A multiplexed in vitro diagnostic test for the detection and identification of respiratory disease causing viruses and bacteria from upper respiratory tract specimens, providing results for 24 extracted DNA samples in less than 3 hours with a simple workflow.

Drive fluid consumable for MAGPIX System, available for IVD and RUO use.

Modular, flexible software package for control of MAGPIX, Luminex 200, and FLEXMAP 3D instruments with customizable GUI and automated routine operations.

FDA-cleared real-time RT-PCR assay for rapid and accurate detection of SARS-CoV-2 from suspected COVID-19 symptomatic individuals, using a sample-to-answer system with no extraction and all-in-one reagents.

Fast, flexible and accurate Group A Strep testing.

Consists of inactivated Group A Streptococcus (GAS) bacteria for use in infectious disease molecular assays.

The FIRST FDA de-novo granted assay for the in vitro qualitative detection of Candida auris colonization.

A high-quality quantitative CLIA assay that assesses disease severity in patients with suspected infection by detecting Mid-regional pro-adrenomedullin (MR-proADMTM) via a single test, ideal for patients at ED and ICU.

Multiplex protein assay system for SARS-CoV-2 antibody detection.

Extended multiplex nucleic acid testing panel for coronaviruses.

Proven technology for easier high-throughput nucleic acid assays.

Software platform for controlling and analyzing multiplex immunoassay data.

The discrimination of all H5N1 strains from human patients with a recent positive flu A test

The xMAP® Antibody Coupling Kit provides everything needed to couple an antibody to MagPlex Microspheres and to easily separate magnetic beads from solution.

Help clinicians detect and identify the most common CFTR mutations.

The first complete solution with optimal diagnostic performance for Bordetella pertussis diagnosis including LIAISON® Bordetella pertussis Toxin IgA1 and IgG assays.

Total automation for accurate differential diagnosis of Parvovirus B19.

Diagnostic solution for the combined detection of IgA and IgG antibodies to Chlamydia trachomatis.

Consists of inactivated adenovirus for use in infectious disease molecular assays.

Automated CLIA assay for qualitative determination of antibodies to Trypanosoma cruzi in human serum and plasma, including post-mortem specimens.

A temperature activated PCR master mix supplied in a 2.5X concentrated solution. Enzyme activity is blocked until heat activated during the initial PCR step. Contains all of the necessary PCR components (enzyme, dNTPs, buffer, MgCl2).

Performance verification kit for MAGPIX System, available for IVD and RUO use.

An assay for rapid detection of Gram-negative bacteria in blood cultures using the VERIGENE® System.

A qualitative, multiplexed molecular test for the simultaneous detection and identification of up to 24 bacterial, viral, and parasitic targets with the flexibility to only test and pay for what is clinically relevant.

xPONENT® is a modular, flexible software package for control of the MAGPIX®, Luminex® 200™, and FLEXMAP® 3D® instruments. It features a graphical user interface customizable to laboratory needs, with navigation wizards and automated routine operations to enhance usability and increase walk-away time.

Consists of inactivated influenza A virus, inactivated influenza B virus, and inactivated RSV for use in infectious disease molecular assays.

A real-time qualitative PCR assay enabling differential diagnosis of Bordetella pertussis and Bordetella parapertussis, the major causative agents of pertussis (whooping cough).

Consists of inactivated varicella-zoster virus for use in infectious disease molecular assays.

For the quantitative determination of anti-trimeric spike protein specific IgG antibodies to SARS-CoV-2 in human serum or plasma samples.

Reagents for xMAP multiplex assay instruments.

Oligonucleotide-coupled polystyrene microparticles dyed into spectrally distinct sets, each with a unique 24 base DNA sequence (anti-TAG) covalently coupled to its surface, allowing custom bead array design by hybridizing complementary TAG sequences to the beads. Magnetic for easy separation and compatible with all xMAP® instruments including MAGPIX® System.

xPONENT® software package for laboratories working under FDA’s 21 CFR Part 11 regulations, offering multilevel user management, full audit trail, electronic records, and electronic signatures.

Software platform for multiplex assay data management and analysis.

Consists of inactivated HSV 1 & 2 viruses for use in infectious disease molecular assays.

Total automation for accurate differential diagnosis of measles virus.

Consists of inactivated SARS-CoV-2 viral particles for research use only, not for diagnostic procedures.

A next generation IGRA based-test assay that delivers faster, accurate, and highly efficient automated TB testing—enabling laboratories to increase throughput, ensure reliable results, and accelerate early detection of Mycobacterium tuberculosis infections.

For amplification and detection of the 3′ region of the gene for adenovirus hexon polypeptide with a FAM labeled forward primer.

Developed for low reaction volume applications and supplied in a 2.5X concentration solution. Contains all of the necessary PCR components (enzyme, dNTPs, buffer, MgCl2).

A high salt PCR master mix supplied in a 2.5X concentration solution. Contains all of the necessary PCR components (enzyme, dNTPs, buffer, MgCl2, KCl).

A highly scalable gastrointestinal test with customizable detection of bacterial, viral, and parasitic pathogens to rule out the causes of infectious diarrhea. It provides fast, comprehensive results within 5 hours and detects over 90% of causative agents of gastroenteritis.

A qualitative test intended for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from upper respiratory tract specimens collected from individuals with clinical signs and symptoms of a respiratory tract infection.

Yearly Operational Qualification (OQ) service to confirm system reliability of any xMAP4 instrument in the laboratory.

Comprehensive flu strain coverage and monitoring ensure test confidence.

Comprehensive flu strain coverage and monitoring ensure test confidence.

Positive control pack for the Simplexa® C. difficile Direct Kit, used to ensure assay accuracy and reliability.

Consists of inactivated Bordetella bacteria for use in infectious disease molecular assays.

Only targeted FDA cleared in vitro qualitative PCR assay for the direct detection of VZV from CSF samples.

For amplification and detection of the NS3 gene with a CFR610 labeled forward primer.

The FLEXMAP 3D® platform offers fast read time, compatibility with 96- and 384-well plates, and ease of integration with front-end automation systems. It uses magnetic and non-magnetic microspheres and can simultaneously measure up to 500 genes or proteins from a small sample. Automated routines make it easy to use and maintain.

A fast, robust, flow-based analyzer combining fluorescently dyed microspheres, flow cytometry detection, and xPONENT® software for multiplex assay data acquisition and analysis.

Multiplex assay for detecting Flu A/B, RSV, and COVID-19 viruses, designed for use with the LIAISON NES® Instrument.

PC supplied by Luminex with xPONENT® 4.3 software pre-installed, providing basic functionality for instrument control, data acquisition, and data reduction.

Panel ensuring improved diagnostic accuracy in detecting Lyme borreliosis infection, including LIAISON® LymeDetect® for early stage detection and serologic IgG and IgM LIAISON® Borrelia tests.

Complete EBV panel for accurate differential diagnosis of infection stage using a LIAISON® system.

Consists of a DNA fragment of a well conserved region of EBV LMP2A gene for use in infectious disease molecular assays.

Immunoassay test for detection of Lyme disease antibodies.

For amplification and detection of the 5′ region of the gene for adenovirus hexon polypeptide with a FAM labeled forward primer.

Secure xPONENT® package allowing administrator setup of user access levels, includes all basic functionality.

For amplification and detection of the Chikungunya virus Alpha E1 Glycoprotein gene with a FAM labeled forward primer.

Swabs used for sample collection compatible with the LIAISON NES® system.

Lysis solution for use in sample preparation of fungus/yeast for PCR applications.

A multiplexed in-vitro diagnostic test for the detection and identification of 19 viral pathogens including SARS-CoV-2, and two bacterial pathogens from extracted nucleic acid samples in a single well, enabling thorough respiratory health analysis.

The MAGPIX® System is a cost-effective, streamlined imaging-based analyzer that simultaneously measures up to 50 analytes in a single microplate well. It is a compact, imaging-based instrument designed to analyze multiplex assays performed using Luminex proprietary xMAP® Technology.

The MAGPIX4 System is a cost-effective, streamlined imaging-based analyzer that simultaneously measures up to 50 analytes in a single microplate well using Luminex proprietary xMAP4 Technology.

Installation Qualification (IQ) and Operational Qualification (OQ) services performed by Field Service Engineers to ensure proper installation and operation of the MAGPIX System.

FDA-cleared real-time RT-PCR assay for rapid and accurate detection of SARS-CoV-2 from suspected COVID-19 symptomatic individuals, using a sample-to-answer system with no extraction and all-in-one reagents.

Positive control pack for the Simplexa COVID-19 & Flu A/B Direct assay.

For amplification and detection of the NS5 gene with a FAM labeled forward primer.

A multiplexing platform supporting both immunoassays and nucleic acid assays, used for biomarker characterization, pathogen detection, gene expression analysis, and more.

Help patients recover from gastrointestinal infections more quickly

Help clinicians identify mutations indicative of adverse effects with certain drugs.

The LIAISON® MDX real-time PCR system simplifies quality-enhanced run processing for reliable patient testing leveraging minimal sample input without extraction for efficient, flexible, and faster clinical outputs using an expansive and differentiated test menu on simple testing modalities, including open mode capabilities for maximal utilities.

The only FDA-cleared PCR assay for detection of congenital CMV in both saliva swabs and urine.

High-throughput, fully automated CLIA assay to quickly differentiate between bacterial and viral infections in a single procedure, combining host-immune protein measurements for acute infection diagnosis.

Module allowing communication with external Laboratory Information System (LIS) databases for export/import of patient data in ASTM format, may require middleware.

Consists of a DNA fragment containing a well conserved region of CMV UL83 gene for use in infectious disease molecular assays.

Differential serological diagnosis of Mycoplasma Pneumoniae for effective patient management.

Total automation for accurate differential diagnosis of mumps virus.

Consists of a DNA fragment of a well conserved region of BKV VP2 gene for use in infectious disease molecular assays.

An RNA template and labeled primer pair used as a process control to detect systemic variation during extraction and amplification steps of real-time RT-PCR assays.

Buffered enzyme to transcribe RNA templates into cDNA.

The VERIGENE® System is a sample-to-answer, economical, multiplex molecular diagnostic platform that enables rapid identification of pathogens responsible for complex infectious diseases. It offers flexible solutions aligned with clinical and reimbursement guidelines, suitable for hospital-based and centralized reference labs.

Integrates with standard-of-care workflow for molecular detection and differentiation of 27 targets including 19 gram-negative bacteria and 8 resistance genes associated with bacteremia.

Consists of Inactivated SARS-CoV-2 virus, inactivated influenza A virus, inactivated influenza B virus, inactivated RSV virus for use in infectious disease molecular assays.

Consists of inactivated SARS-CoV-2 virus, inactivated influenza A virus and inactivated influenza B virus for use in infectious disease molecular assays.

Fast, flexible and accurate Group A Strep testing.

For the quantitative determination of SARS-CoV-2 nucleocapsid protein antigen in nasal swab (NS), nasopharyngeal swab (NPS), in individuals suspected to have COVID-19 by their healthcare provider within the first ten days from the onset of symptoms and in nasopharyngeal swab (NPS) in asymptomatic subjects.

A CLIA assay for quantitative determination of procalcitonin in human serum and plasma, aiding risk analysis for critically ill patients regarding bacterial infection progression.

The xMAP INTELLIFLEX® System is a compact, flow-based, multiplex platform combining xMAP® Technology with modern features for enhanced performance, assay development innovation, and simplified user experience. It offers low- and high-plex capabilities, quick time to reliable results, and the ability to acquire data for two parameters per analyte simultaneously.

Multiplex nucleic acid testing system for respiratory and other pathogen panels.

Multiplex nucleic acid test assay for SARS-CoV-2 detection.

Multiplex assay kit for cystic fibrosis genetic markers.

A mixture of 80 MagPlex-TAG® Microsphere regions designed to facilitate nucleic acid array development with 80 or fewer targets. Compatible with Luminex® 200™ and FLEXMAP 3D® instruments running xPONENT® software; MAGPIX® detects only 50 of the 80 regions.

Module enabling communication between the reader and a front-end automation platform, including device driver support.

Total automation for accurate staging of CMV infection.

Total automation for accurate differential diagnosis of Herpes Simplex Virus.

Consists of inactivated Dengue virus including serotypes 1, 2, 3, and 4 for use as a molecular control.

Consists of inactivated Group B Streptococcus bacteria for use in infectious disease molecular assays.

A magnetic separator designed for a single 1.5 mL reaction tube, typically used in bead coupling reactions to quickly separate 1 mL of MagPlex® Microspheres from solution, suitable for small-scale coupling reactions and nucleic acid and protein assay preparation.

For amplification and detection of a well conserved region of the VP2-VP3-VP1 genes of BK polyomavirus with a FAM labeled probe, forward primer, and reverse primer.

A multiplex real-time sample-to-answer PCR test for detection and differentiation of SARS-CoV-2, influenza A, influenza B, and RSV in nasopharyngeal swabs.

A system designed to run the NxTAG Respiratory Pathogen Panel v2 assay for respiratory pathogen detection.

A multiplex, real-time PCR-based test that qualitatively detects nucleic acid from 2 bacterial and 20 viral respiratory pathogens, including SARS-CoV-2, from nasopharyngeal swab samples.

A qualitative, multiplexed molecular test for the simultaneous detection and identification of up to 24 bacterial, viral, and parasitic targets with the flexibility to only test and pay for what is clinically relevant.

For the quantitative determination of SARS-CoV-2 nucleocapsid protein antigen in nasal swab (NS), nasopharyngeal swab (NPS), in individuals suspected to have COVID-19 by their healthcare provider within the first ten days from the onset of symptoms and in nasopharyngeal swab (NPS) in asymptomatic subjects.

Immunoassay analyzer designed for large laboratories combining high throughput and high sensitivity within a powerful and fully automated system that can seamlessly connect to facilitate Total Laboratory Automation.

The VERIGENE System is a sample-to-answer molecular diagnostic platform that rapidly identifies pathogens responsible for infectious diseases, including bloodstream, respiratory, and gastrointestinal infections. It offers automated sample preparation and test processing with minimal hands-on time and flexible assay options including PCR and direct DNA detection.

A high-performance standalone COVID-19 testing assay used during pandemic peaks, providing simple utility and reliable results.

A multiplex assay for rapid and accurate detection and differentiation of SARS-CoV-2, influenza A, influenza B, and RSV directly from nasopharyngeal and anterior nasal swabs, providing critical diagnostic support in a single streamlined test.

A molecular multiplex panel that detects 21 different pathogens (bacteria and viruses), including SARS-CoV-2, designed for high throughput laboratories with ready-to-use lyophilized reagent wells.

A point of care, real-time RT-PCR test used on the patented LIAISON NES instrument to detect influenza A, influenza B, RSV, and SARS-CoV-2 viruses in dry nasal swabs in approximately 15 minutes.

A real-time RT-PCR assay run on LIAISON® MDX to detect Flu A, Flu B & RSV in one sample with a simple sample-to-answer workflow and no RNA extraction needed.

A 21-target syndromic panel for comprehensive and customizable Flex Testing in complex or immunocompromised cases.

A sample-to-answer assay for detection and differentiation of influenza A/B and RSV with broad strain coverage.

The first commercial test that allows the user to choose any combination of 16 viral and bacterial targets for an individual sample at the time of test ordering, based on the clinician and patient’s needs, paying only for the targets reported. It offers a flexible respiratory pathogen testing algorithm that addresses clinician and patient needs while minimizing financial and resource burden on the laboratory.

A flexible, multiplexed respiratory panel for syndromic testing that identifies the most common respiratory pathogens with the flexibility to pay for only selected pathogens within the comprehensive panel.

A real-time RT-PCR assay run on the LIAISON NES® instrument to detect influenza A, influenza B, respiratory syncytial virus, and SARS-CoV-2 from a single nasal swab sample in approximately 15 minutes, enabling rapid and accurate respiratory pathogen detection for timely diagnosis and treatment.

Positive control pack for Simplexa® Flu A/B & RSV Direct assay, used for quality control in diagnostic testing.

Positive control pack for the Simplexa® Bordetella Direct assay, used to ensure assay performance and accuracy.

An assay that differentiates key Bordetella species (B. pertussis and B. parapertussis) in pertussis-suspected patients in about 1 hour, ideal for outbreak-related testing.