Diagnostic performance, user acceptability, and safety of unsupervised SARS-CoV-2 rapid antigen-detecting tests performed at home.

BACKGROUND: One strategy for reducing spread of COVID-19 is to contain the infection with broad screening, isolating infected individuals, and tracing contacts. This strategy requires widely available, reliable SARS-CoV-2 testing. To increase testing, rapid antigen detection tests (RADTs) were developed for self-sampling, self-testing, and self-interpretation. This study examined diagnostic performance, user acceptability, and safety of nasal self-RADTs compared with polymerase chain reaction (PCR) testing. METHODS: Self-RADT kits were distributed at a public COVID-19 test center in Aarhus, Denmark or delivered to participants. Participants reported test results and test preferences. During enrollment, participants reported occurrence and duration of symptoms consistent with COVID-19. Sensitivity and specificity of self-RADT, relative to oropharyngeal PCR testing, were calculated. RESULTS: Among 827 participants, 102 showed positive PCR test results. Sensitivities of the self-RADTs were 65.7% (95% confidence interval [CI]: 49.2-79.2; DNA Diagnostic) and 62.1% (95% CI: 50.1-72.9; Hangzhou), and specificities were 100% (95% CI: 99.0-100; DNA Diagnostic) and 100% (95% CI: 98.9-100; Hangzhou). The sensitivities of both self-RADTs appeared higher in symptomatic participants than in asymptomatic participants. Two of every 3 participants preferred self-RADT over PCR test. CONCLUSION: Self-performed RADTs were reliable, user-acceptable, and safe among laypeople as a supplement to professionally collected oropharyngeal PCR testing.

A targeted expression panel for classification, gene fusion detection and PD-L1 measurements - Can molecular profiling replace immunohistochemistry in non-small cell lung cancer?

The histological classification of non-small-cell lung cancer (NSCLC) and identification of possible therapeutic targets are important for disease management. However, as biopsies are often small, with a limited amount of tumor cells, it can be challenging to obtain enough tissue for the needed number of diagnostic immunohistochemical stains and molecular analyses. In this study, we combined a small custom designed targeted expression panel with a commercial fusion transcript assay by which we were able to perform both a histological classification (transcribing the expression of the genes encoding TTF1, Napsin A, CK5/6, and the truncated P63 isoform ΔNp63 (p40) into either adenocarcinoma or squamous cell carcinoma) and an identification of fusion genes involving ALK, RET, and ROS1. The expression panel also included the PD-L1 encoding gene, CD274, in order to evaluate the PD-L1 mRNA potential for identification of patients who will benefit from immune checkpoint inhibitor treatment. We evaluated the panel using 42 NSCLC patient samples. The molecular profiling agreed with the original immunohistochemistry (IHC)-based classification in 93% of the cases. For ten of the patients, being fusion gene positive, the fusion transcripts were detected in 100%. The molecular assessment of PD-L1 also showed agreement with the original assessment made by IHC. In conclusion, this study presents a small, targeted expression panel with the potential to perform both a molecularly based histological classification and a fusion gene identification in NSCLC patients as well as identifying PD-L1 status from a very limited amount of starting material.