As saliva sampling becomes more widely considered as a method for COVID-19 testing, ConceptoMed brings an easy and accessible solution for saliva collection.
Bringing innovative, high-end medical equipment and technology to the healthcare industry, ConceptoMed develops and manufactures products including test devices, connectors, syringes, holding devices, saliva devices and a health code app.
In particular, ConceptoMed is recognised for its innovations in fluid transfer, with devices to facilitate the safe and efficient transfer of liquids.
Effective saliva collection for COVID-19 testing
The COVID-19 pandemic and the pitfalls of the current testing methods for the SARS-CoV-2 infection have prompted the latest creation from ConceptoMed, the SalivaPOD™.
Since the pandemic began, the ‘gold standard’ for testing has been recognised as the nasopharyngeal swab. However, demand for swabs and the complex and time-consuming nature of this testing process prompted an urgent need for alternative methods, including saliva testing.
A recent article published in the Lancet Respiratory Medicine, discussed an increase in studies to evaluate SARS-CoV-2 detection in saliva. According to the article, 58 studies on the subject had been carried out by November 2020. However, the article authors noted major discrepancies in results between studies. Saliva sampling has presented some challenges regarding the amount of saliva collected (too much or too little), the viscosity of the saliva (often too high viscosity samples that require preparation steps before extraction and analysis), and problems with lumps and mucus in the samples (causes problems with robotic pipetting).
Minimising workload for healthcare professionals and Test-and-Trace teams, the SalivaPOD makes the process of saliva collection quick, simple, and easily accessible. Suitable for home use, the SalivaPOD collects and stores oral fluid from a patient prior to being sent to a laboratory for testing. The single-use device can be used by the patient or by a healthcare professional.
The SalivaPOD ensures that the test subject delivers the correct amount of saliva each time (1 ml to the line, maximum 1.4 ml transferred into transport tube regardless of the amount delivered), and its straw-shaped filtering mouthpiece collects a low viscosity sample, completely free of lumps and mucus.
The sample is directly transferred into a Copan 16 mm 3 ml UTM™ tube, or other compatible 16 mm tubes, to ensure that the sample is easy to work with, easy to pipette, and remains of good quality at room temperature. It is also transferred into the transport tube in a closed system, reducing the risk of contaminating the sample and its surroundings.
The product is 100% developed by ConceptoMed AS in Norway, and manufactured at a fully-automated production facility in Sweden. The capacity available at this facility makes it possible to manufacture millions of units given with just a few weeks’ notice.
SalivaCODE app
To accompany the SalivaPOD, ConceptoMed has also developed a carefully considered app, ‘SalivaCODE’, available on iOS and Android.
The app works as an electronic instruction manual, with video guidance available in several languages, and additional voice instructions are optional. It can also be used to connect each sample to the individual test subject with the unique QR code on the SalivaPOD, with subsequent digital integration into laboratory information management Systems (LIMS).
Tried and tested
In February 2021, a pilot experiment was carried out using the SalivaPOD device by researchers at the Norwegian University of Science and Technology (NTNU). The saliva collection device was given out to 150 recruited students, divided into about 40 different cohorts. The students registered into the SalivaCODE app and linked themselves individually to the relevant cohort by scanning a separate Cohort QR Code, before they subsequently collected saliva samples in their respective homes.
About 120 students delivered a filled saliva sample device to the return station at NTNU in the three-hour time window specified by researchers. Every saliva sample was easily transferred into the compatible Copan 3mL UTM vial at the return point by a researcher. All the tubes containing saliva were successfully analysed with extraction and the RT—PCR technique at St. Olavs Hospital (University Hospital of Trondheim) – without need for pre-analytical preparation before extraction. All vials with saliva/UTM mixture were easy to pipette manually and were regarded as suitable for automatic pipetting steps.
Researchers concluded that the SalivaPOD system on the whole was well-suited for saliva collection and processing for RT-PCR analysis, and for smooth sample information integration with existing LIMS solutions at the various diagnostic labs.
In questionnaires immediately after the pilot, 97% of the subjects found no problems with the SalivaPOD and sampling process. 100% of the students reported willingness to deliver saliva samples with SalivaPOD minimum once a week if this could contribute to an open campus and society policy.
Researchers concluded that the results from the pilot strongly support the notion that home-based saliva collection and cohort pooling are key for achieving a much better control of epidemic spread than current testing protocols due to a much-simplified logistics.
Based on the convincing data regarding saliva as the sample material for Sars-CoV-2 testing, and on the pilot done by NTNU, Trondheim (Norway’s third largest municipality) has decided to make saliva sampling their preferred test method. They have already opened up a separate test station where they exclusively do saliva sampling. They also calculate that they will save at least 40% of the personnel resources by switching to saliva, compared to their existing test method with NP swabs.
Other municipalities in the same region are now following Trondheim to bring a more comfortable test to their residents, and to lower the bar of getting tested.
Additional innovations
In addition to the SalivaPOD innovation, ConceptoMed offers a variety of other solutions to contribute to the fight against infection prevention.
The ThorQ™ Mini FlowStop™ is a multi-functional connector, which can reduce medication spill and work environment contamination by up to 99.9%. ThorQ provides the force you need to disconnect jammed male connections. Even with full flow capacity, the ThorQ Mini FlowStop lever always shuts off the tube flow before disconnection. One-handed release venting cap and default priming position provides a superior tool for medical infusion procedures.
The ThorMix™ CTRL is an infusion line for medical liquids and blood products, especially intended to prevent spill during bedside administration of infusates. ThorMix CTRL is designed to give the users a functional, flexible and user-friendly product. The spike is designed for easy penetration into containers, with stable connection. The drip chamber is flexible and transparent with level marks, making it easy to fill and keep track of drop frequency. The roller-clamp is easy to operate and ensures exact adjustment and maintenance of flow rate.
The SteriJack™ syringe technology facilitates a non-touch technique during connection to and disconnection from medical needle hubs, for example, ensuring an aseptic technique during handling of medication and medical procedures as a whole.
The ZIP Supra™ syringe further integrates a vacuum syringe functionality, with the potential to draw pre-defined or full syringe volumes of liquid, activating the suction with only one hand.
