Dotz Nano, an advanced technology company developing, manufacturing and commercialising marking, tracing and verification solutions, has obtained Australian authorisation to use the CE Mark for its SARS-CoV-2 virus detection technology.
The CE Mark clears the saliva-based diagnostic Dotz Test Kits for sale in the European Union, following the company obtaining authorisation to use the CE Mark for its nasopharyngeal swab-based kits.
The test kit was created and tested for use with both nasopharyngeal swab and saliva samples, and now the Dotz Test Kit has CE Mark authorisation in respect of both nasopharyngeal swab and saliva samples.
Similar to the company’s CE Mark application for its nasopharyngeal swab-based Dotz Test Kits, Systaaq Diagnostic Products was engaged by Dotz and listed as the ISO13485 manufacturer for the saliva-based Dotz Test Kit.
The saliva-based Dotz Test Kit, being saliva based, is less instrusive than the current standard method of sample collection in most parts of the world of nasopharyngeal swab sampling. It is also more simple, convenient and cost efficient than nasopharyngeal swab sampling.
The saliva-based Dotz Test Kit has the following features:
• 100% True Positive Rate for for viral loads of 1250 copies per mL in saliva;
• the limit of detection for the saliva-based Dotz Test Kit is 1,250 copies per mL when using 1mL of input sample.
The True Positive Rates at other copy numbers are as follows:
• 100 per cent specificity, following a negative cross-reactivity results for a range of other viruses;
• test results within 15-17 minutes (when using two heating blocks);
• visual detection by colour change of the reagents; and
• simultaneous testing of up to hundreds of samples using standard heating blocks.