To control the pandemic, we need to be able to compare the performance of each lot and version of the more than 900 different COVID‐19 diagnostics in use worldwide

Goal:
To control the pandemic, we need to be able to compare the performance of each lot and version of the more than 950 different COVID‐19 diagnostics in use worldwide

Authors:
Ana Szarfman, John C. Bloom, Lawrence Callahan, Mark Geanacopoulos, and Frank Weichold

Consequences of the lack of unique identifiers
In early September 2014, CDC distributed a request to vaccine manufacturers asking them to identify any non-traditional lot convention in use for vaccines sold in the U.S. market. Without a uniform coding system for vaccines by lot, it was impossible for electronic systems to accurately relate a vaccination encounter to vaccine inventory.(1) Like with vaccines, there is also a need to avoid the use of non-interoperable conventions to identify the over 950 COVID-19 diagnostic tests by lot in use worldwide.(2) The coding variations and the resulting lack of unique interoperable identifiers for each one of the diagnostic tests by lot in use pose a challenge for the prompt and proper monitoring of the evolving pandemic. Without having an interoperable unique identification by lot for COVID-19 diagnostic tests, it is impossible to adequately distribute calibrated positive and negative controls and low and high standards for quantitative analysis, and the appropriate unknown specimens for accreditation. With the shortage of laboratory supplies and reagents that need to be constantly replaced, and their lack of unique identifiers, it has been quite difficult to optimize their distribution, and therefore to properly update the calibration and assessment of the performance of each of the diagnostic tests in use. It has also been difficult to understand the variations in sensitivity and specificity and predictive values of these evolving tests. These problems also complicate the identification of the prevalence of the infection in different communities being tested by this diverse array of diagnostic tests worldwide. The lack of universal, unique identifiers for each patient properly linked to each of his/her health providers and health facilities also complicates linking the test results to each corresponding patient to understand complicating factors, as well as the evolving prevalence of the disease (not only the infection). The lack of a simple, unique interface between the laboratory performing the testing and the unique patient identifiers by unique health providers and health facilities, also complicates the linkage to patient information, and delays conveying the information to the health provider and corresponding authorities. This common problem unfortunately delays the identification of risk factors and best treatment options in a pandemic. It also complicates the rapid reporting of the arrival of corrupted data to the end user or when critical information is missing. For example, without receiving the assessment of the limit of detection of each test by lot, it becomes impossible for health professionals to interpret the consequences of pooling specimens. The lack of consistent and transparent coding and traceability makes these data to remain largely underused or misused for effective and prompt decision-making.

1.. https://repository.immregistries.org/files/re...cine_table_.pdf

2. SARS-CoV-2 diagnostic pipeline.
https://www.finddx.org/covid-19/pipeline/