SpeciMAX Dx Saliva Collection Kit for In Vitro Diagnostics

SpeciMAX Saliva Collection Kit for raw saliva

The SpeciMAX Dx Saliva Collection Kit is intended for the collection of raw or unprocessed saliva specimens as an aid to molecular testing for In Vitro Diagnostic purposes.

The new SpeciMAX Dx Saliva Collection Kit gives labs the ability to offer molecular diagnostic testing where non-invasive saliva samples types are used. This new saliva collection tubes are sterilized, barcoded, and heat tolerant, and compatible for higher throughput automated workflows. Sterilized tubes help to improve safety and 1D barcode on the tube enables accurate sample tracking.

The SpeciMAX Dx Saliva Collection Kit comes as an individual single-use peel sterilized pouch that includes an easy-to-use funnel, saliva collection tube, and a screw cap to secure the sample once collected.

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This product is only available in select countries including Ireland, Malta, Germany, Switzerland, Belgium, Austria, Luxembourg, Spain, Sweden, Finland, Norway, Denmark, Lithuania, Netherlands, Czech Rep, Slovakian Rep, Croatia, Greece, Cyprus, Italy, Poland, France, Portugal and Hungary. Regulatory requirements vary by country; products may not be available in your geographic area.

Key features of the SpeciMAX Dx Saliva Collection Kit

Easy-to-use with non-invasive collection capability
- Easy-to-use, spill-resistant, single-use funnel and saliva collection tube allows for convenient, rapid and effortless collection
- Secures 1 mL saliva in 6 mL transfer tube
Heat tolerance
- SpeciMAX Dx collection tubes with 1D-barcode (on the tube) are heat-tolerant, making them automation-friendly and enabling automatic processing workflows and virus heat inactivation
Helps to keep patient and healthcare professional safe
- A major advantage of using saliva as a specimen is that it is non-invasive, thereby minimizing many safety concerns for both patients and healthcare professionals
Standardized and optimized saliva collection and sample accessioning
- Individually packaged, easy-to-peel sterilized pouches
- Tubes are compatible with automation racks and decappers for downstream workflow. This helps to eliminate manual and time-consuming tube de-capping and saliva pipetting when using a liquid handler or sample transfer system
- 95 kPa compliant saliva collection tubes for secure transport
Compatible with downstream workflows
- Compatible with nucleic acid extraction and direct to PCR workflows
Save time and money
- Did you know collection of saliva specimen compared to nasopharyngeal swab can save $636,105 per 100,000 patients sampled by reducing the need for manual labor [1,2]?Save cost and time by using saliva specimen for SARS-CoV-2 testing.

How SpeciMAX Saliva Collection kit can help save time

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Workflow for the SpeciMAX Dx Saliva Collection Kit with Taqpth COVID-19 Fast PCR Combo Kit 2.0 (CE-IVD)

SpeciMAX Dx Saliva Collection Kit and Taqpath COVID-19 Fast PCR Combo Kit 2.0 (CE-IVD) workflow

Available in Ireland, Malta, Germany, Switzerland, Belgium, Austria, Luxembourg, Spain, Sweden, Finland, Norway, Denmark*, Lithuania, Netherlands, Czech Rep, Slovakian Rep, Croatia, Greece, Cyprus, Italy, Poland and France, Portugal and Hungary*.
*Not Available to comarket/sell with TaqPath Fast PCR 2.0 CE-IVD

References

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.
Vogels CBF, Brackney DE, Wang J, et al. SalivaDirect: Simple and sensitive molecular diagnostic test for SARS-CoV-2 surveillance. Preprint. medRxiv. 2020;2020.08.03.20167791

Technical specifications of the SpeciMAX Dx Saliva Collection Kit


Intended use/intended purpose	The SpeciMAX Dx Saliva Collection Kit is intended for use to collect raw or unprocessed salivaspecimens as an aid to molecular testing for In Vitro Diagnostic purposes. The SpeciMAX Dx Saliva Collection Kit is intended for use in the presence of healthcare professionals to collect patient saliva samples.
Included in the kit	Spill-resistant funnel, pre-filled capped 6 mL sterilized and barcoded collection tubes.
Input volume	1 mL
Sample type	Saliva specimens
Length of storage	Follow handling and storage instructions from assay manufacturer for detailed conditions. We recommend immediate processing upon collection or freezing for longer term storage. We have demonstrated saliva stability of at least three days at –20°C storage, 24 hours at 4°C, and room temperature storage conditions.
Downstream analysis	Nucleic acid extraction and direct to PCR workflows
Devices/kit	400
Cat. No.	A51022

Resources

Application Note: Detection of SARS-CoV-2 using the SpeciMAX Dx Saliva Collection Kit paired with fast PCR

For In Vitro Diagnostic Use.

This product is only available in select countries including Ireland, Malta, Germany, Switzerland, Belgium, Austria, Luxembourg, Spain, Sweden, Finland, Norway, Denmark, Lithuania, Netherlands, Czech Rep, Slovakian Rep, Croatia, Greece, Cyprus, Italy, Poland and France, Portugal and Hungary. Regulatory requirements vary by country; products may not be available in your geographic area

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