MEETING IVDR REQUIREMENTS & MORE WITH NEW CE-IVD chemagic™ NUCLEIC ACID PURIFICATION KITS
What is IVDR?
In vitro diagnostic (IVD) manufacturers have been busy bees in the past months, working intensively to meet the new European Union regulations known as the European In Vitro Diagnostic Medical Device Regulation (EU IVDR) that come into play 26th May 2022.
Under the EU IVDR which replaces the older In Vitro Diagnostic Medical Devices Directive (IVDD), a higher emphasis is placed on quality management systems and post-market surveillance, with more stringent conformity assessments for IVD products based on their risk classification. The overarching benefit is a high level of safety for patients and users derived from having a continuous, transparent, and traceable process for in vitro device performance.
New chemagic™ CE-IVD Kits – Combining Quality, Flexibility & Speed
With that, Perkinelmer chemagen has launched new IVDR compliant kits that are suitable for nucleic acid purification on chemagic instruments in clinical workflows.
To meet a faster turnaround time, the new IVD kits (Table 1) can be applied for diverse sample types in a single workflow. These kits join our already existing IVD kits which cater to fixed volumes and sample types. For a complete kit overview: https://chemagen.com/products/ce-ivd-chemagic-kits/
When applied with the chemagic 360 instrument, a broad range of sample volumes can be processed by easily switching across the 12, 24 or 96 Rod Head Sets (Table 2). The movement of M-PVA Magnetic Beads as opposed to liquids and gentle spinning rod head technology ensures best-in-class nucleic acid integrity (with fragment sizes up to ~200 kb) alongside high yields and purity. All this while maintaining run times of 79 minutes or less (18 minutes achievable for SARS-CoV-2 RNA extraction) for up to 96 samples.
Nucleic acids isolated with chemagen technology have been successfully applied to a wide array of downstream applications. These include PCR, microarrays, Next Generation Sequencing, methylation assays, MLPA and more. The high DNA/RNA quality also allows samples to be stored over longer periods of time without a significant drop in quality, making it ideal for biobanking applications.
Table 1. New IVD kits from chemagen for automated nucleic acid purification
|Product Number||Product Name||Samples & Volumes Applicable|
|IVD-1033-S||chemagic™ Viral DNA/RNA 300 Kit H96||300 µl Plasma, Saliva, or Swabs|
|IVD-1091||chemagic™ BBS DNA Kit H96||250-400 µl Blood, Buffy Coat, Saliva|
|IVD-1074||chemagic™ BBS DNA Kit H24||2-4 ml Blood
Up to 2 ml Buffy Coat
Up t o4 ml Saliva
|IVD-704||chemagic™ BBS DNA Kit H12||Up to 10 ml Blood
Up to 2 ml Buffy Coat
Up t o4 ml Saliva
Table 2. chemagic Rod Head Sets cater to a broad range of sample volumes
Supporting Clinical Workflows
These kits are ideal for supporting clinical workflows and have diverse applications in pathogen detection and genetic testing.
Sensitive & High-throughput Pathogen Detection
The chemagic™ Viral DNA/RNA 300 Kit H96 was used with the chemagic 360 instrument during the coronavirus pandemic to support efficient, high-throughput SARS-CoV-2 testing. Together with the new 18 min ultrafast extraction protocol and PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay which has the market’s lowest limit of detection (LOD) for SARS-CoV-2, sensitive and reliable tests were performed at throughputs and speeds previously unimaginable.
“We are using PerkinElmer model chemagic™ 360 (Automated Nucleic Acid Extraction system) installed in our laboratory for COVID-19 testing. We are running 32 min. short protocol (recently updated by the PerkinElmer Team) and getting good result with our RT PCR. Due to this short protocol we are able to run approx. 4000 samples / day with two instruments, The instrument supplied has been functioning well, satisfying the requirements of our applications and meeting our expectations for quality and reliability of the data generated.”
Department of Microbiology, Government of Rajasthan, S.M.S. Medical School, Jaipur
Similar PCR or sequencing-based workflows could be applied for other species with a 60 minute extraction protocol. With good fulfilment of reproducibility, repeatability, and linearity of extraction yield, performance with chemagic systems also showed no cross-contamination.
Reliable Genetic Testing for Diverse Applications
The chemagic™ BBS (blood, buffy coat, saliva) DNA Kits have been used for the reliable purification of high-quality nucleic acids for a variety of downstream genetic tests not limited to those found in Table 3. Due to the best-in-class nucleic acid integrity, even challenging assays such as long-read sequencing can be performed with chemagen extracted nucleic acids.
Table 3. Examples of downstream assays and applications employed following nucleic acid extraction with chemagen technology
|Sample Type||Downstream Assay(s)||Application||Reference|
|Blood & Swabs||PCR, qPCR, NGS||ABO Genotyping||Lang, K., Wagner, I., Schöne, B. et al. ABO allele-level frequency estimation based on population-scale genotyping by next generation sequencing. BMC Genomics 17, 374 (2016). https://doi.org/10.1186/s12864-016-2687-1|
|Blood||Bisulfite sequencing, methylation arrays (Illumina), PCR||Epigenetic analysis||Wiechmann, T., Röh, S., Sauer, S. et al. Identification of dynamic glucocorticoid-induced methylation changes at the FKBP5 locus. Clin Epigenet 11, 83 (2019). https://doi.org/10.1186/s13148-019-0682-5|
|Blood||MLPA, Long-range PCR, NGS, Sanger Sequencing||Germline Lynch syndrome testing||Evans DG, Lalloo F, Ryan NA, et al. Advances in genetic technologies result in improved diagnosis of mismatch repair deficiency in colorectal and endometrial cancers. Journal of Medical Genetics 59, 328-334 (2022) http://dx.doi.org/10.1136/jmedgenet-2020-107542|
|Blood||Long-read Sequencing (Oxford Nanopore)||Characterization of structural variants||Beyter, D., Ingimundardottir, H., Oddsson, A. et al. Long-read sequencing of 3,622 Icelanders provides insight into the role of structural variants in human diseases and other traits. Nat Genet 53, 779–786 (2021). https://doi.org/10.1038/s41588-021-00865-4|
|Saliva||Whole Genome Sequencing||Chemotherapy effects on the inherited genome||Kryukov, G. v., Bielski, C. M., Samocha, K. et al. Genetic Effect of Chemotherapy Exposure in Children of Testicular Cancer Survivors. Clinical Cancer Research, 22(9), 2183–2189 (2016) https://doi.org/10.1158/1078-0432.CCR-15-2317|
Safety & Traceability Assured
We know the importance of patient samples, hence these features that come with CE-IVD chemagic instruments, help maintain sample integrity while ensuring samples, reagents and runs are tracked every step of the way. All while delivering a safe working environment for laboratory personnel.
- Barcode reading of samples, eluates and kits
- LIMS compatible log files
- Pre-installed protocols
- Safe travel path for pipetting arm
- Remote monitoring
- Optimal buffer dispensing
Explore our CE-IVD instrument offerings, designed to meet your range of automation needs and throughputs.
chemagic™ 360-D Instrument
chemagic™ Prime™ Junior-D Instrument
For an overview of chemagen IVD Products visit https://chemagen.com/products/chemagen-ivd-products-overview/
Products may not be licensed in accordance with the laws in all countries, such as the United States and Canada. Please check with your local representative for availability.