The cobas SARS-CoV-2 Variant Set 1 for use on the cobas 6800/8800 Systems is an automated, multiplex, real-time RT-PCR assay for the qualitative detection and differentiation of SARS-CoV-2 mutations N501Y, deletion HV-69/70 and E484K in e.g., nasal and nasopharyngeal swab specimens from patients with known SARS-CoV-2 infection to support the understanding of variant epidemiology for Population Health Management. The assay is intended for research use only and is not for use in diagnostic procedures.
The SARS-CoV-2 Rapid Antibody Test is a reliable, rapid chromatographic immunoassay intended for qualitative detection of antibodies (IgM and IgG) to SARS-CoV-2 in human serum, plasma or whole blood. It is intended for the use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating prior infection. The rapid lateral flow test is intended for professional use in laboratory and near patient-testing environments and qualitatively detects IgM and IgG specific to SARS-CoV-2 in serum, plasma, and whole blood.
The SARS-CoV-2 Rapid Antigen Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of SARS‑CoV‑2 nucleocapsid antigen present in human nasal samples. The test is intended to detect antigen from SARS‑CoV‑2 in individuals suspected of COVID‑19 or with known or suspected exposure to SARS‑CoV‑2. The product is intended for professional use in laboratory and Point of Care environments, or self-collection under the supervision of a healthcare worker.
The Elecsys SARS-CoV-2 Antigen assay uses monoclonal antibodies directed against the SARS-CoV-2 N protein in a double-antibody sandwich assay format for the qualitative detection of SARS-CoV-2 in upper respiratory tract specimens.
The cobas SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas Liat System is a multiplex real-time polymerase chain reaction (PCR) test that detects and differentiates SARS-CoV-2, influenza A and influenza B in 20 minutes from a single nasal sample and in just one test. It is intended for use in the detection and differentiation of SARS-CoV-2, influenza A, and influenza B in clinical specimens and is not intended to detect influenza C. SARS-CoV-2, influenza A and influenza B viral RNA is generally detectable in upper respiratory specimens during infection.
The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx. This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19 and is strictly intended for professional use in laboratory and Point of Care environment.
The Elecsys Anti-SARS-CoV-2 S is an immunoassay for the in vitro quantitative determination of antibodies (including IgG) to the SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum and plasma. The assay uses a recombinant protein representing the RBD of the S antigen in a double-antigen sandwich assay format, which favors detection of high affinity antibodies against SARS‑CoV‑2. The test is intended as an aid to assess the adaptive humoral immune response to the SARS‑CoV‑2 S protein.
The cobas SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory viral infection consistent with COVID-19 by their healthcare provider. The test runs on the cobas 6800/8800 Systems and has a full-process negative control, positive control and internal control. It is the first commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample.
The cobas SARS-CoV-2 Test is a qualitative assay that allows the detection of nucleic acids in samples from patients who meet COVID-19 (coronavirus) clinical and/or epidemiological criteria and is intended for use on the automated, high throughput cobas 6800/8800 Systems. The single-well dual target assay includes both specific detection of SARS-CoV-2 (COVID-19 Coronavirus) and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes SARS-CoV-2.
The Elecsys Anti-SARS-CoV-2 is an immunoassay intended for qualitative detection of antibodies to SARS‑CoV‑2 in human serum and plasma (K2‑EDTA, K3‑EDTA, Li‑heparin) to be used as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection. The electrochemiluminescence immunoassay (ECLIA) uses a recombinant protein representing the nucleocapsid (N) antigen for the determination of antibodies against SARS-CoV-2 and is intended for use on cobas e immunoassay analyzers.
The Elecsys IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL 6 (interleukin 6) in human serum or plasma and is used to help clinicians quickly identify COVID-19 patients with severe inflammatory response who need mechanical ventilation. The Elecsys IL-6 immunoassay is an electrochemiluminescence immunoassay (ECLIA) and is intended for use on cobas e immunoassay analyzers.
Roche (Basel, Switzerland) and GenMark Diagnostics, Inc. (Carlsbad, CA, USA) have entered into a definitive merger agreement for Roche to fully acquire GenMark which provides molecular diagnostic tests that are designed to detect multiple pathogens from a single patient sample.
Under the new framework of a Global Business Partnership Agreement (GBP) signed between Roche (Basel, Switzerland) and Sysmex Corporation (Kobe, Japan), both the companies have renewed their commitment to their long standing Distribution, Sales and Service (DSS) agreement, allowing Roche to continue to distribute Sysmex hematology products, including instruments and reagents.
Roche (Basel, Switzerland) has announced the CE-IVD launch of its automated digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis for breast cancer to help determine the best treatment strategy for each patient.
Roche (Basilea, Suiza) ha lanzado Roche Healthcare Consulting, un servicio de consultoría especializado que tiene como objetivo ayudar a los líderes en los laboratorios, hospitales y otros grupos de atención médica a optimizar su desempeño operativo, clínico y financiero.
Roche (Basel, Switzerland) has launched Roche Healthcare Consulting, a specialized consulting service that aims to help leaders in laboratories, hospitals and other healthcare groups optimize their operational, clinical and financial performance.
The MagNA Pure 24 System is a fully-automated clinical nucleic acid extraction system that offers walkaway automation, minimum user intervention, and extraction-to-extraction variability. It is capable of extracting nucleic acids from a wide range of human sample types with a single universal reagent kit, along with on-board primary sample handling for low to medium throughput users who require high quality nucleic acid extractions.