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Tag Archives: Randox Laboratories

Randox releases bladder cancer array

March 2024—Randox has released its female bladder cancer array, designed to help clinicians stratify patients presenting with hematuria. The array detects interleukin-12p70, interleukin-13, midkine, and clusterin from a single urine sample to determine an individual’s biomarker risk score. A person’s risk for developing bladder cancer is determined by combining the biomarker risk score with clinical risk scores generated using the company’s algorithms.

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Randox introduces PSA and BNP control

June 2023—Randox Labs has released two new products, a prostate-specific antigen and brain natriuretic peptide control. The liquid-frozen PSA is manufactured using human serum and has an open-vial stability of 30 days at 2°–8°C and a shelf life of one year from the date of manufacture. The control is optimized for use with Roche systems but is also suitable for use across a variety of other platforms, the company says.  

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Randox SARS-CoV-2 antibody control

February 2021—Randox introduced its Acusera SARS-CoV-2 Antibody Control with reactive and nonreactive controls for anti SARS-CoV-2 to support assay validation and routine performance monitoring of serological assays for COVID-19. The third-party control is supplied in a liquid, ready-to-use format with a 30-day open vial stability at 2° to 8°C.

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Randox multiplex controls for respiratory disease

January 2021—Randox Laboratories has unveiled its Qnostics Multiplex Respiratory Pathogen Controls for respiratory diseases, including for SARS-CoV-2, influenza A and B, and respiratory syncytial virus. The RTX controls are used to monitor the full testing process, from extraction to amplification and detection, and are compatible with a majority of commercial and in-house assays.

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Randox unveils cytokine tests

August 2020—Randox Laboratories has unveiled cytokine testing for COVID-19 risk stratification and treatment monitoring. The tests look for the presence of cytokines and are performed using Randox’s Biochip technology, which can detect up to 12 cytokines and growth factors from a single patient sample. The testing menu includes 26 cytokines across four biochip panels.

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Randox STI assay gets CE mark

April 2020—Randox announced that its Randox STI assay has received the CE mark. The multiplex assay detects 10 STIs, including co-infections, from a single patient sample. It tests simultaneously for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, Treponema pallidum, HSV-1, HSV-2, Haemophilus ducreyi, Mycoplasma hominis, and Ureaplasma urealyticum.

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Vivalytic test for detecting SARS-CoV-2

April 1, 2020—Randox Laboratories and Bosch Healthcare Solutionswill launch this month the Vivalytic Viral Respiratory Tract Infection Array, which can identify SARS-CoV-2 and differentiate it from nine other respiratory infections with similar symptoms, including influenza and all known coronaviruses.

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Direct HbA1c testing in whole blood

December 2019—The Randox RX series provides laboratories with the capabilities of onboard HbA1c testing in whole blood on three fully automated RX analyzers—RX Modena, RX Imola, and RX Daytona+ —to accommodate rapid and reliable measurement of HbA1c in different laboratory settings.

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Randox unveils stroke test, controls

September 2019—Randox launched at the AACC annual meeting the Randox Stroke Biochip, a highly sensitive blood test that complements CT scanning technology to facilitate accurate classification of stroke patients. The test differentiates between ischemic and hemorrhagic stroke, directs the appropriate patient care pathway, and enables rapid thrombolytic therapy.

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Randox RX Daytona+ 510(k) cleared

July 2019—Randox announced FDA 510(k) clearance for its RX Daytona+ clinical chemistry analyzer. The RX Daytona+ test menu includes routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants, and diabetes and is capable of performing emergency stat sampling. The fully automated benchtop analyzer has a combined throughput of 450 tests per hour, including ISE.

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Randox teams up with Bosch

March 14, 2018—Randox Laboratories and Bosch Healthcare Solutions will unveil Vivalytic, a fully automated molecular diagnostics platform, at the 28th European Congress of Clinical Microbiology and Infectious Diseases, April 21–24, in Madrid. Vivalytic supports end-point PCR, quantitative real-time PCR, melting curve analysis, and microarray technology, enabling singleplex, low-plex, and high multiplex testing on the same device. Depending on the test ...

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Updated interlaboratory data management program, 5/17

May 2017—Randox has launched Acusera 24.7 Live Online 2.0, which is faster than the previous version, has a simplified user interface, and an enhanced user experience. The biggest update to version 2, according to a company statement, is the ability to review peer data in real time, which enhances troubleshooting capabilities and allows labs to identify trends.

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FDA-cleared multianalyte control, 2/15

February 2014—The FDA has cleared Randox’s Acusera Liquid Assayed Chemistry Premium Plus, a multianalyte control containing 100 commonly used analytes, for use in U.S. laboratories. Randox believes the “super control” will revolutionize quality control in laboratories, saving time and money while ensuring accurate results and patient diagnosis.

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Randox FDA-cleared controls, 6/14

June 2014—Randox’s Acusera HbA1c received FDA clearance. It is a 100 percent human whole blood, lyophilized control with assayed values provided for high-performance liquid chromatography and a wide range of clinical chemistry analyzers. When reconstituted the control remains stable for four weeks at 2°–8°C. The control is available in levels 1 and 2, and a calibrator is also available.

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Liquid BNP control, 5/13:87

Randox Laboratories’ Acusera liquid BNP control is for use in the routine monitoring of accuracy and precision. Assayed instrument-specific target values and ranges are provided for Beckman Access, Abbott Architect, and Siemens Advia Centaur instruments. The BNP control is a 100 percent human serum, manufactured to the high-quality standards associated with all Acusera controls.

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