"RAD tests enabled prompt detection of SARS-CoV-2 infection which had pronounced effects on LoS at the ED. Negative VitaPCR enabled cessation of IPC measures and a negative test was associated with increased targeted admissions, reduced intrahospital transfers and shorter LoS at the hospital."

"This in vitro study provides data for the effect of primer mismatches on PCR performance. It highlights the fact that experimental data does not necessarily follow the theoretical predictions, particularly with regard to the magnitude of the ct shift with mismatches close to the 3’ end. This emphasizes the importance of using more than one target in a diagnostic SARS-CoV-2 RT-PCR (or any other diagnostic PCR for that matter) to counteract PCR dropouts due to mutations. With several targets a PCR drop out or relative shift in ct values compared to the other targets used can actually serve as an indication for a mutation, prompting further investigation of the sample by genome sequencing. Furthermore, it emphasizes the importance to remain vigilant with regard to new mutations and their potential effect on PCR performance. In this context it is also important to keep in mind the underrepresentation of genome data from some geographical regions (e.g. Africa), which may lead to mutations from these regions being overlooked, despite causing problems in diagnostics in these regions."

The COVID-19 pandemic accelerated the shift of RT-PCR diagnostics from central labs to portable Point-of-Care (POC) devices. By leveraging Lab-on-a-Chip technology, systems like those from Visby, Cepheid, and Abbott provide gold-standard sensitivity and results in under 50 minutes without requiring specialized staff. Despite challenges such as high costs and potential false negatives from poor sampling, these miniaturized systems are crucial for decentralized testing and future pandemic preparedness.

"In conclusion, the rapid PoC PCR-based tests, in combination with consistent safety practices such as face masks, social distancing, quarantining and risk-based exposure questions have shown to be reliable methods for continuing operations at CRUs and for safeguarding the safety of subjects participating in clinical trials and of the site staff. In addition, the PoC PCR tests have shown to be a useful tool for excluding SARS-CoV-2 infection in an asymptomatic healthy volunteer population. The results from our PoC tests in combination with gold standard PCR have been instrumental in keeping SARS-CoV-2 infections out of our clinics and thus limited the risk of COVID-19 on the conduct of clinical trials. Collaboration between experts from the bioanalytical laboratories, the clinical chemistry laboratories, the medical and operational staff in the CRUs and company management ensured safe and effective continuation of early phase clinical trials during the COVID-19 pandemic and helped to ensure safety of trial subjects."

"The importance of children in transmitting the virus remains uncertain; however our analysis of the distribution of the infection in these subjects may help monitor SARS-CoV2 spread in the general population."

"The strategy implemented in our study has allowed us to significantly reduce (from 50 to 75%) times for analysis, equipment, consumables, and personnel costs while maintaining the same sensitivity. In addition, the possibility to be admitted to the hospital on the same day on which the swab is performed is extremely important for our patients (mainly affected by intellectual disability/dementia). Given the current epidemiological situation with a significant increase in PCR tests, such measures could help laboratories to lighten their workload and contain costs."

This study reveals a significant discrepancy in the virucidal efficacy of SARS-CoV-2 reagents. While most guanidine-free extraction buffers successfully inactivated the virus, the majority of rapid antigen test (LFIA) buffers were ineffective, with only three of twelve meeting safety standards. These results indicate that rapid testing procedures often fail to neutralize the infectious virus, necessitating strict biocontrol measures and enhanced personal protection to mitigate the risk of laboratory-acquired infections during point-of-care testing.

"The VitaPCR™ SARS-CoV-2 is an accurate rapid test, suitable for clinical practice that can be performed as part of a point-of-care testing, for the rapid diagnosis of COVID-19."

The IHU Méditerranée Infection effectively navigated the COVID-19 pandemic by transitioning from theory to massive, rapid action. Despite global shortages, the Institute managed over 430,000 tests and thousands of patients by drastically scaling its Point-of-Care (POC) diagnostics and adapting its infrastructure. The success of the strategy relied on early diagnosis to reduce contagiousness and strict biosafety protocols, which resulted in zero infections among BSL-3 laboratory staff. Ultimately, the IHU's experience proves that institutional resilience depends on the ability to rapidly upgrade equipment and clinical circuits in response to a high-throughput health crisis.

The review concludes that while traditional laboratory-based systems like the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel and the Allplex 2019-nCoV Assay (Seegene) offer high reliability, there is a clear shift toward rapid, automated "sample-to-result" platforms. A primary example is the VitaPCR™ SARS-CoV-2 assay, which is highlighted for its ability to provide results in just 20 minutes, making it one of the fastest molecular diagnostic tools compared in the study. This is contrasted with other rapid systems like the Xpert Xpress SARS-CoV-2 (Cepheid), which takes approximately 45 minutes, and the Idylla™ SARS-CoV-2 Test (Biocartis), which requires 90 minutes.

"High-sensitivity testing is needed to limit nosocomial spread and identify asymptomatic COVID-19 patients. However, time advantage of the VitaPCR [compared to extraction-based reference assays: Aptima® (Hologic Panther TMA), cobas® 6800 (Roche), and Xpert® Xpress (Cepheid GeneXpert)] must be weighed against its significantly lower sensitivity [compared to extraction-based reference assays: Aptima® (Hologic Panther TMA), cobas® 6800 (Roche), and Xpert® Xpress (Cepheid GeneXpert)], especially when used in high-risk environments such as hospitals."

In summary, the comparison shows that while most molecular platforms are highly reliable, the Cepheid Xpert Xpress and Roche Cobas Liat emerge as the most sensitive rapid options, consistently meeting the strictest limits of detection. In contrast, multiplex platforms like the BioMerieux BioFire, Qiagen QIAstat-Dx, and GenMark ePlex offer broader diagnostic reach but sometimes sacrifice sensitivity or fail to provide viral load data (Ct values). While devices such as the Credo Diagnostics VitaPCR and MobiDiag Novodiag provide speed, they show limitations in detecting low viral loads compared to high-throughput laboratory kits like ThermoFisher TaqPath or Seegene Allplex, which remain the gold standard for large-scale, resilient testing.

The study demonstrates that both the Credo VitaPCR™ Flu A&B and the Cepheid Xpert® Xpress Flu/RSV platforms serve as highly effective rapid point-of-care (POC) nucleic acid amplification tests (NAATs) for hospital settings. While both devices exhibited comparable usability and identical specificity, the VitaPCR™ system achieved higher user satisfaction scores due to its faster turnaround time of 20 minutes. Analytically, both platforms showed excellent reliability and high sensitivity for detecting influenza A/B RNA when compared to standard multiplex RT-PCR, making them both dependable tools for the rapid diagnosis of symptomatic patients.

"Finally, our observations confirm high usability and good appreciation of VitaPCR™ platform for its short duration of analysis (20 min), the little place occupied, and the possibility of point‐of‐care use, although only a single sample analysis is considered as a limiting factor. Furthermore, the analytical performances of the VitaPCR™ platform were high and close to those of reference rRT‐PCR in the event of significant viral load. In conclusion, the VitaPCR™ SARS‐CoV‐2 Assay is an accurate rapid point‐of‐care NAAT, suitable for clinical practice for the rapid diagnosis of COVID‐19, especially in patients with COVID‐19‐suspected symptoms."

"Considering our results, we suggest that VitaPCR™ might be useful as a first-line screening test in the ED for older adults, to quickly identify and isolate positive patients. On the other hand, if the patient needs to be admitted to a hospital ward, a negative result should be confirmed by a laboratory-based NAAT."