TITLE: ThEA Direct Swab 
AUTHORS: Miriam Schwartz, Nikhil Ponon, Caleb Stewart, Luke Saban, Jody Ranck

[DESCRIPTION]
<div class = "text-blocks"><div class = "text-block">RAM Group has developed ThEA™ - an optical, reagent free / chemical free detection system for rapid diagnosis for SARS-Cov-2. The system consists of a THz spectrometer, a low-cost disposable sensor cartridge and a set of classification algorithms. ThEA’s < 60s detection time allows rapid screening at the point of sample collection or quick-turnaround batch processing from a central location. The primary goal of the current study is to clinically validate the ThEA classification algorithm. This can be accomplished by testing several patient samples at the point of collection in a controlled environment. The key learning outcomes of this study will be determining how well the ThEA classification algorithm is able to identify SARS-Cov-2 features from the THz data collected from patient. The classification accuracy will in turn be evaluated by cross checking versus PCR control tests done by the institution for the same patient cohort. </div><div class = "text-block">The test includes taking an oropharyngeal swab from the patient and directly smearing it on the sensor surface followed by reading out the THz response in a THz time domain spectrometer. ThEA analysis software with classification algorithm will then be able to classify whether the sample is infectious with Sars-Cov-2 virus or not.</div></div>

[STEPS]
?. [Calibration]
Take a measurement of air and save to DB, i.e. no sample in beam optical path (once per hour) – Air spectrum.
?. [Calibration]
Scan the barcode and take a measurement of the calibration cartridge provided - Substrate spectrum, once per hour just after Air measurement in previous step and save to DB.
?. [Measurement]
Take an oropharyngeal swab and smear on the sensor surface two times in an 'x’ pattern.
?. [Measurement]
Enter the metadata of the patient sample under test in the ThEA measurement software. Enter details about sourcing pts, traceability, agree to follow up etc without compromising personal information. Scan the barcode of the 'ThEA Rapid' cartridge to be used.
?. [Initialization]
Initialize measurement, data logging software (ThEA measurement) and analysis (ThEA Analysis) software.
?. [Initialization]
Start the temperature, humidity logger and bar code scanner.
[The entire experiment runs at room temperature]
?. [Measurement]
Take a measurement of the bare sensor – Reference spectrum, for every patient sample to be performed.
?. [Measurement]
Take a measurement of the sensors and save to DB– Measurement spectrum.
?. [Measurement]
Dispose of the one-time use sensor and the swab.
Follow local rules for disposal
?. [Calibration]
Insert the calibration cartridge in the cartridge holder and press 'Substrate'
?. [Measurement]
Insert the cartridge in the cartridge holder and press 'Reference'
?. [Measurement]
Insert the cartridge in the cartridge holder and press 'Measurement'
?. [Measurement]
Open 'ThEA' analysis software and load 'Reference' file followed by 'Measurement' file and press 'Analyze'
?. [Measurement]
Result is displayed on the screen. Possible outcomes are: 'Positive', 'Negative', 'Inconclusive'.
?. [Calibration]
Keep the calibration cartridge in its original packaging for future use.
?. [If Inconclusive]
Take a new oropharyngeal swab
?. [If Inconclusive]
Repeat step 5 to 10 using 'ThEA Advanced' cartridge.