Thermo Scientific™ SpeciMAX™ Dx Saliva Collection Kit

Description

• The Thermo Scientific SpeciMAX Dx Saliva Collection Kit is intended for the collection of unprocessed saliva specimens in the presence of healthcare professionals as an aid in nucleic acid-based polymerase chain reaction (PCR) for in vitro diagnostic purposes
• The individual single-use peel-pouch sterilized kit comes with an easy-to-use funnel, a saliva collection tube, and a screw cap to secure the sample after collection
• The SpeciMAX Dx automation-friendly saliva collection tube and serialized 1D barcode label (on the tube) are tolerant to heat, making integration into automatic processing workflows and virus heat inactivation possible
• Features of the SpeciMAX Dx Saliva Collection Kit include: Individual single-use peel-pouch sterilized kit Viral heat inactivation—collection tube and barcode label tolerant to heat Sample storage at room temperature—seven days for viral nucleic acid Non-invasive, simple, quick saliva collection Barcoded, standardized tubes and caps that fit automated workflows Instrumental in high-throughput diagnostic testing Advantages of saliva as a diagnostic sample type One major advantage to saliva collection and testing is that it is non-invasive, alleviating many safety concerns for both patients and healthcare workers
• As saliva-based diagnostics have become more common for SARS-CoV-2 testing, advantages over nasopharyngeal swabs—the gold standard method—have become more obvious
• The latter triggers sneezing and coughing for patients, which increases the risk of viral transmission and causes mild to severe discomfort in patients (1)
• Saving on cost In the case of SARS-CoV-2 testing, saliva testing is equally sensitive as nasopharyngeal testing, yet much less costly, saving $636,105 per 100,000 persons sampled
• Easy to use Each SpeciMAX Dx Saliva Collection Kit comes ready to use in individually packaged easy-peel sterilized pouches
• To use the kit, the saliva donor follows four easy steps: Attach the funnel securely to the collection tube
• Fill saliva to between the 1.0 and 2.0 lines (not including bubbles)
• Remove and discard the funnel (do not reuse)
• Secure the cap on the tube
• For best results, saliva donors should be instructed to refrain from eating, drinking, using tobacco products, or chewing gum for at least 30 minutes for best results
• Saliva donors should allow saliva to pool in their mouths and then drool the saliva into the top of the funnel affixed to the saliva collection device
• Consider the liquid portion of the saliva, not the bubbles, when determining if enough saliva has been collected
• Compatible with nucleic acid extraction or direct-to-PCR workflows Unprocessed saliva specimens offer labs the ability to flex between molecular biology workflows
• Users can extract viral RNA and DNA from human saliva samples using KingFisher instruments with the MagMAX Viral/Pathogen II Nucleic Acid Isolation Kit (Cat
• No
• A48383; saliva-specific extraction protocols approved for CE-IVD and US IVD), QuantStudio real-time PCR systems and assays, and QuantStudio Design and Analysis Software
• Or, unprocessed saliva specimens can be used directly in real-time reverse transcription polymerase chain reaction (rRT-PCR) such as in the SalivaDirect assay
• This product contains components that are manufactured under a license from Isohelix, a division of Cell Projects Limited
• Certifications CE/IVD Compliance CE/IVD