SpeciMAX™ Dx Saliva Collection Kit

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 (2-4). 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: 1. Attach the funnel securely to the collection tube. 2. Fill saliva to between the 1.0 and 2.0 lines (not including bubbles). 3. Remove and discard the funnel (do not reuse). 4. Secure the cap on the tube. (See figure below for pictorial instructions.) 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 (5). This product contains components that are manufactured under a license from Isohelix, a division of Cell Projects Limited. References: 1. Application Note: Saliva sampling using the SpeciMAX Saliva Collection Kit 2. Bastos ML, Perlman-Arrow S, Menzies D, Campbell JR. The Sensitivity and Costs of Testing for SARS-CoV-2 Infection With Saliva Versus Nasopharyngeal Swabs: A Systematic Review and Meta-analysis. Ann Intern Med. 2021;174(4):501-510. 3. Butler-Laporte G, Lawandi A, Schiller I, Yao M, Dendukuri N, McDonald EG, Lee TC. Comparison of Saliva and Nasopharyngeal Swab Nucleic Acid Amplification Testing for Detection of SARS-CoV-2: A Systematic Review and Meta-analysis. JAMA Intern Med. 2021 Mar 1;181(3):353-360. 4. Vogels CBF, et al. SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity. Med (N Y). 2021 Mar 12;2(3):263-280.e6. 5. Yale School of Public Health, Department of Epidemiology of Microbal Diaseases Saliva Direct assay EUA Summary