Data logistics
To enable efficient handling of thousands of tests per day, we implemented a logistics scheme, which is centered at a self-developped web server wioth associated data bank, which acts both as a custom laboratory information management system and as portal to communicate test results to test subjects. To safeguard subjects' privacy, all samples are identified only by the sample tube barcode. Identifying information (subject's name, address, and phone number) is collected but encrypted in a manner that makes this data wholly inaccessible to the project team. (See below for details.)
The logistics concept is best described by following the "life" of a test tube: First, test kits (Figure XX) are packed, comprising standard items (saline bottle and straw), as well as Micronics sample tube with a preprinted barcode. While packing these into a platic bag, this barcode is scanned and transmitted to the server, which assigns a random 12-digit access code and stores the pairing of barcode and access code. The access code is printed, along with instructions, onto a paper slip, which is folded (to keep the access code hidden) and packed into a small plastic bag together with the rest of the kit. We found that a single worker can easily pack XX such test kits in an hour. We produced bags of 50 test kits, which were handed out to entities (e.g., institutes participating in the test), and distributed there.
A participant would take a kit, go to the web page mentioned in the instructions on the paper slip, and find there a short video demonstrating the sampling procedure, as well as a form to register the kit, i.e., associate the access code with their name, address and phone number. These personal information were immediately encrypted by the web server (see below). Furthermore, information on the test is displayed and the user is asked to confirm informed consent.
After registration on the web page, the subject would then take a sample by gargling and deposit the sample tube in a collection receptacle.
When a new batch of samples was received in the lab, these were heat inactivated and then immediately scanned, in order to mark the samples in the data base as received. Similarly, the results of the LAMP analysis were transferred to the server by our custom-built LAMP plata analysis tool (see below). In the same manner, the results of follow-up tests, such as PCR or repeats of LAMP, were recorded as "events" for the sample. The possibility to thus inspect the "history" of a sample was an important feature to troubleshoot any logistics issues.