Importance: A major barrier for successful therapeutic approaches to COVID-19 is the inability during the viral replication stage, when drugs with potential antiviral activity could demonstrate efficacy and preclude progression to more severe stages. Reasons that hamper an earlier diagnosis of COVID-19 include the unspecific and mild symptoms during the first stage, the delay in the diagnosis and specific management caused by the requirement of a rtPCR-SARS-CoV-2 for the diagnosis of COVID-19, and the insufficient sensitivity of the a rtPCR-SARS-CoV-2, oppositely to what is recommended for a screening test during an outbreak. More sensitive and earlier diagnostic tools for COVID-19 should be unraveled as a key strategy for an breakthrough change in the disease course and response to specific therapies, particularly those that target the blockage of viral shedding. We aimed to create an accurate, sensitive, easy-to-perform and intuitive clinical scoring for the diagnosis of COVID-19 without the need of a rtPCR-SARS-CoV-2 (termed as The AndroCoV Clinical Scoring for COVID-19 Diagnosis), resulted from a 1,757 population cohort, eo eventually encourage the management of patients with high pre-clinical likelihood of presenting COVID-19, independent of a rtPCR-SARS-COV-2 test, to avoid delays and loss of appropriate timing for potential therapies.
Materials and methods: This is a post-hoc analysis of clinical data prospectively collected of the Pre-AndroCoV and AndroCov Trials, that resulted in scorings for clinical diagnosis of COVID-19, based on the likelihood of presenting actual COVID-19 according to the number of symptoms, presence of anosmia, and known positive household contact. Sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and accuracy were calculated for subjects screened in two different periods and both periods together, for females, males and both, in a total of nine different scenarios, according to combinations between one, two, or three or more symptoms, or presence of anosmia in subjects without known positive household contacts, and no symptoms, one, two, or three or more symptoms, or presence of anosmia or ageusia in subjects with known positive household contacts. Scorings that yielded the highest pre-test probability, sensitivity and accuracy were selected.
Results: Of the 1,757 patients screened, 1,284 were diagnosed for COVID-19. The scoring that required: 1. Two or more symptoms, or anosmia or ageusia alone, for subjects without known contact; or 2. One or more symptoms, including anosmia or ageusia alone, when with known positive contacts presented the highest accuracy (80.4%) among all combinations attempted, and higher sensitivity (85.7%) than rtPCRSARS-CoV-2 commercially available kit tests.
Conclusion: The AndroCoV Clinical Scoring for COVID-19 Diagnosis demonstrated to be a feasible, easy, costless, and sensitive diagnostic tool for clinical diagnosis of COVID-19. Because clinical diagnosis of COVID-19 avoids delays in specific treatments, particularly for high-risk populations, prevents false-negative diagnosis, and reduces diagnostic costs, this diagnostic tool should be considered as an option for COVID-19 diagnosis, at least while SARS-CoV-2 is the prevailing circulating virus and vaccination rate is below the required for herd immunity.