The SCIEX Topaz System is designed specifically to meet the unique needs of the clinical diagnostic lab, lowering the barriers to adoption of LC-MS and making it accessible to the entire clinical lab staff. The heart of the system lies within the innovative ClearCore MD software, a platform which simplifies and streamlines workflows and method development and incorporates features that enhance usability to help new users build proficiency quickly. In addition, the first FDA-cleared (via the de novo pathway) LC-MS based Vitamin D assay kit, the SCIEX Vitamin D 200M Assay, is for use on the SCIEX Topaz System. According to the Centered for Disease Control (CDC), LC-MS technology is the gold standard method for testing vitamin D, as it offers greater specificity and less cross-reactivity over immunoassay methods. The Vitamin D 200M Assay Kit has successfully met the rigorous performance criteria established by the CDC’s Vitamin D Standardization-Certification Program (VDSCP). The assay individually quantitates both vitamin D2 and D3 while also separating out the D3 epimer, providing the specificity to deliver an accurate measurement of vitamin D status. The Topaz System offers both an open system for lab-developed tests (LDTs) and a closed system for running locked, pre-validated assays.
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The ScanStation is a real-time incubator and colony counting station designed for the pharmaceutical, agro-food and cosmetic industries as well as research. It provides centralized incubation, detection and colony counting of 100 Petri dishes simultaneously. In classical Pasteurian microbiology, the Petri dish must be placed in an incubator for 24h and up to 5 days. Then a time-consuming reading operation is performed to count colonies. The operator may notice the presence of invasive or confluent colonies mixed with air bubbles or debris, increasing the margin of error on the final result. The ScanStation provides results as soon as 6 hours after the beginning of the incubation which is up to 3 times sooner, faster and with unequalled accuracy. The ScanStation detects and counts colonies as soon as they appear at the beginning of the incubation. It is a real-time process, providing anticipated results, saving time and allowing earlier release of production batches. With this new technology, microbiologists can actually see, in real-time, the video of bacterial growth on the Petri dishes. This innovation is a mix between classic methods with the Petri dish and the latest innovations in robotic and computing, providing analyses’ results with unequalled accuracy and much sooner. The major innovation of the ScanStation is the automatic counting of the colonies at an early stage of their development, starting at the beginning of the incubation cycle. Up to 100 Petri dishes are counted every 30 minutes throughout the process, delivering a video recording of the bacterial growth. Final results are known 3 times sooner and faster because up to 100 Petri dishes are processed simultaneously and with superior accuracy as colonies are detected before clustering or covering can occur.

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Bio-Rad Laboratories has made its entry into the rapidly growing molecular diagnostics testing market with the launch of Amplichek II quality control, which was recently issued a de novo clearance from the U.S. Food and Drug Administration (FDA). The FDA’s de novo clearance is a classification given to devices that are considered novel, with no existing classification or predicate device on the market. Amplichek II began shipping last May and is the first in a series of infectious disease controls that Bio-Rad is introducing for the molecular diagnostic testing market. Molecular diagnostics is one of the fastest growing IVD markets, estimated to reach $9.3 billion (€8.5 billion) by 2020 with the infectious disease segment accounting for the largest share of the global market, according to a 2015 report by research firm MarketsandMarkets. The Amplichek II quality control complements the company’s already extensive range of quality controls. Amplichek II is an independent, multi-analyte quality control that monitors the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of healthcare associated infections (HAIs). HAIs can occur during the process of patient care within a healthcare facility. Millions of healthcare associated infections occur each year, leading to significantly high mortality rates. According to the Centers for Disease Control and Prevention, on any given day, about one in 25 hospital patients have at least one healthcare associated infection. Early detection of these pathogens combined with the appropriate infection control procedures can help prevent the spread of HAIs and lead to improved patient care.
The Amplichek I quality control, which was recently issued a 510(k) clearance from the U.S. Food and Drug Administration (FDA) is the second in a series of infectious disease controls that Bio-Rad is introducing for the molecular diagnostic testing this year. Amplichek I is an independent, multi-analyte quality control for the assessment of HIV-1, Hepatitis B (HBV) and Hepatitis C (HCV) nucleic acid tests that can help mitigate the limitations of manufacturer controls. Unlike some controls that are optimized for specific systems, Amplichek I can help reduce the risk associated with reporting inaccurate patient results by monitoring the performance of the complete analytical process and detecting lot-to-lot variation of assay reagents.

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The newly CE marked FilmArray Respiratory Panel 2 plus (RP2plus) tests for 22 pathogens (18 viruses and 4 bacteria) responsible for respiratory tract infections. It advances the existing FilmArray Respiratory Panel (RP) by reducing the assay time from about an hour to less than 45 minutes, improving overall sensitivity, and updating several assays. FilmArray RP2plus also includes 2 additional pathogens: Bordetella parapertussis, one of the causative agents of pertussis or whooping cough, a highly infectious bacterial disease, and Middle East Respiratory Syndrome coronavirus (MERS-CoV). According to the WHO, the recent MERS-CoV outbreak in the Republic of Korea demonstrated a great potential for widespread transmission and severe disruption both to the health system and to society. The MERS-CoV case fatality rate is approximately 36%. Bordetella parapertussis infections represent a significant cause of whooping cough which is oft en missed because of a clinical presentation largely indistinguishable from other viral infections and of lack of reliable diagnostic tests. The FilmArray RP2plus is available for use on the FilmArray 2.0 and FilmArray Torch systems and will be commercially available in the countries that recognize CE marking by mid-June 2017.
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