SARS-CoV-2 screening in patients in need of urgent inpatient treatment in the Emergency Department (ED) by digitally integrated point-of-care PCR: a clinical cohort study

Möckel, Martin; Bolanaki, Myrto; Hofmann, Jörg; Stein, Angela; Hitzek, Jennifer; Holert, Fabian; Fischer-Rosinský, Antje; Slagman, Anna

doi:10.1016/j.diagmicrobio.2022.115637

Cited by 5 publications

(4 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Previous studies have evaluated the clinical performance of the cobas Liat SARS-CoV-2 & Influenza A/B test compared with other RT-PCR systems, such as the Cepheid ® GeneXpert system ® (26) and the cobas SARS-CoV-2 test on the cobas 6800/8800 Systems (27), and have demonstrated 100% positive percent agreement and 97–100% negative percent agreement. One study, conducted in an ED in Germany, estimated that POC PCR results using the cobas Liat System were available after 102 minutes from admission, which was shorter than the 811 minutes with central laboratory PCR (28). Though the TAT observed in the clinic is longer than the 20-minute assay run time, demonstrating some delay in the testing strategy, time to result is still substantially shorter than for centralized PCR methods.…”

Section: Discussionmentioning

confidence: 99%

A study to assess the impact of cobas Liat point-of-care PCR assays (SARS-CoV-2 and Influenza A/B) on patient clinical management in the emergency department of the University of California at Davis Medical Center

May

Robbins

Canchola

et al. 2022

Preprint

View full text Add to dashboard Cite

Background Rapid detection of SARS-CoV-2 is crucial for reduction of transmission and clinical decision-making. The cobas® SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas Liat® System is a rapid (20 minutes) point-of-care (POC) polymerase chain reaction (PCR) method. Methods This unblinded, pre-post study enrolled consecutive patients with symptoms/signs consistent with SARS-CoV-2 infection presenting to the University of California, Davis emergency department (ED). Outcomes following implementation of the cobas Liat SARS-CoV-2 & Influenza A/B test (intervention period: December 2020 to May 2021) were compared with previous standard-of-care using centralized laboratory PCR methods (control period: April 2020 to October 2020). Results Electronic health records of 8879 symptomatic patients were analyzed, comprising 4339 and 4540 patient visits and 538 and 638 positive SARS-CoV-2 PCR test results in the control and intervention periods, respectively. Compared with the control period, turnaround time (TAT) was shorter in the intervention period (median 0.98 vs 12.3 hours; p<0.0001). ED length of stay (LOS) was generally longer in the intervention period compared with the control period, but for those SARS-CoV-2-negative who were admitted, ED LOS was shorter (median 12.53 vs 17.93 hours; p<0.0001). Overall, the rate of anti-infective prescribing was also lower in the intervention period than in the control period (antibiotics only: 38.11% vs 44.55%; p<0.0001 and antivirals only: 3.13% vs 0.94%; p<0.0001). Conclusion This real-world study confirms faster TAT with a POC PCR method in an emergency care setting and highlights the importance of rapid SARS-CoV-2 detection to aid patient management and inform treatment decisions.

show abstract

Section: Discussionmentioning

confidence: 99%

A study to assess the impact of cobas Liat point-of-care PCR assays (SARS-CoV-2 and Influenza A/B) on patient clinical management in the emergency department of the University of California at Davis Medical Center

May

Robbins

Canchola

et al. 2022

Preprint

View full text Add to dashboard Cite

show abstract

“…The goal of comparing Ct values between these technologies was to assess whether DASH can provide meaningful semi-quantitative viral load measurements, similar to laboratory-based PCR, but at POC and quick enough to potentially influence clinical or public health guidance. A more accurate comparison between DASH and Xpert would involve preparing standard specimens with known virus concentrations and processing them with both technologiesc [ 45 ]. Unfortunately, this was outside of the scope of this clinical validation study evaluating SARS-CoV-2 detection using DASH.…”

Section: Discussionmentioning

confidence: 99%

Clinical evaluation of the Diagnostic Analyzer for Selective Hybridization (DASH): A point-of-care PCR test for rapid detection of SARS-CoV-2 infection

et al. 2022

View full text Add to dashboard Cite

Background An ideal test for COVID-19 would combine the sensitivity of laboratory-based PCR with the speed and ease of use of point-of-care (POC) or home-based rapid antigen testing. We evaluated clinical performance of the Diagnostic Analyzer for Selective Hybridization (DASH) SARS-CoV-2 POC rapid PCR test. Methods We conducted a cross-sectional study of adults with and without symptoms of COVID-19 at four clinical sites where we collected two bilateral anterior nasal swabs and information on COVID-19 symptoms, vaccination, and exposure. One swab was tested with the DASH SARS-CoV-2 POC PCR and the second in a central laboratory using Cepheid Xpert Xpress SARS-CoV-2 PCR. We assessed test concordance and calculated sensitivity, specificity, negative and positive predictive values using Xpert as the “gold standard”. Results We enrolled 315 and analyzed 313 participants with median age 42 years; 65% were female, 62% symptomatic, 75% had received ≥2 doses of mRNA COVID-19 vaccine, and 16% currently SARS-CoV-2 positive. There were concordant results for 307 tests indicating an overall agreement for DASH of 0.98 [95% CI 0.96, 0.99] compared to Xpert. DASH performed at 0.96 [95% CI 0.86, 1.00] sensitivity and 0.98 [95% CI 0.96, 1.00] specificity, with a positive predictive value of 0.85 [95% CI 0.73, 0.96] and negative predictive value of 0.996 [95% CI 0.99, 1.00]. The six discordant tests between DASH and Xpert all had high Ct values (>30) on the respective positive assay. DASH and Xpert Ct values were highly correlated (R = 0.89 [95% CI 0.81, 0.94]). Conclusions DASH POC SARS-CoV-2 PCR was accurate, easy to use, and provided fast results (approximately 15 minutes) in real-life clinical settings with an overall performance similar to an EUA-approved laboratory-based PCR.

show abstract

“…Since this study seeks to evaluate SARS-CoV-2 screening instruments, all adult ED patients with the need for inpatient admission, who were willing and able to give written informed consent, were eligible for study participation. Patients requiring urgent intervention after ED admission received direct POC testing to prevent time delay as presented by Möckel et al [ 21 ] and were therefore excluded from this study. Patients who were younger than 18 years, under legal guardianship, and those who had received SARS-CoV-2 rtPCR testing within the last 48 hours or presented to the ED multiple times during study conduction were excluded too.…”

Section: Methodsmentioning

confidence: 99%

“…The gold standard for detecting SARS-CoV-2 infections is the real-time polymerase chain reaction (rtPCR) test [ 13 ]. Early on in the pandemic, POC diagnostic instruments became available, such as the Roche cobas® Liat® (LIAT), a POC rtPCR test for SARS-CoV-2 with high sensitivity and specificity [ 21 ]. Rapid antigen tests were also quickly developed and implemented; however, they are not solely suitable to rule out SARS-CoV-2 infections due to their reduced sensitivity [ 22 ].…”

Section: Introductionmentioning

confidence: 99%

Effects of Different SARS-CoV-2 Testing Strategies in the Emergency Department on Length of Stay and Clinical Outcomes: A Randomised Controlled Trial

Boldt,

Bolanaki,

Holert

et al. 2024

Canadian Journal of Infectious Diseases and Medical Microbiolog

Self Cite

View full text Add to dashboard Cite

The turn-around-time (TAT) of diagnostic and screening measures such as testing for SARS-CoV-2 can affect a patient’s length of stay (LOS) in the hospital as well as the emergency department (ED). This, in turn, can affect clinical outcomes. Therefore, a reliable and time-efficient SARS-CoV-2 testing strategy is necessary, especially in the ED. In this randomised controlled trial, n = 598 ED patients presenting to one of three university hospital EDs in Berlin, Germany, and needing hospitalisation were randomly assigned to two intervention groups and one control group. Accordingly, different SARS-CoV-2 testing strategies were implemented: rapid antigen and point-of-care (POC) reverse transcription polymerase chain reaction (rtPCR) testing with the Roche cobas® Liat® (LIAT) (group one n = 198), POC rtPCR testing with the LIAT (group two n = 197), and central laboratory rtPCR testing (group three, control group n = 203). The median LOS in the hospital as an inpatient across the groups was 7 days. Patients’ LOS in the ED of more than seven hours did not differ significantly, and furthermore, no significant differences were observed regarding clinical outcomes such as intensive care unit stay or death. The rapid and POC test strategies had a significantly (p<0.01) shorter median TAT (group one 00:48 h, group two 00:21 h) than the regular central laboratory rtPCR test (group three 06:26 h). However, fast SARS-CoV-2 testing strategies did not reduce ED or inpatient LOS significantly in less urgent ED admissions. Testing strategies should be adjusted to the current circumstances including crowding, SARS-CoV-2 incidences, and patient cohort. This trial is registered with DRKS00023117.

show abstract

SARS-CoV-2 screening in patients in need of urgent inpatient treatment in the Emergency Department (ED) by digitally integrated point-of-care PCR: a clinical cohort study

Cited by 5 publications

References 11 publications

A study to assess the impact of cobas Liat point-of-care PCR assays (SARS-CoV-2 and Influenza A/B) on patient clinical management in the emergency department of the University of California at Davis Medical Center

A study to assess the impact of cobas Liat point-of-care PCR assays (SARS-CoV-2 and Influenza A/B) on patient clinical management in the emergency department of the University of California at Davis Medical Center

Clinical evaluation of the Diagnostic Analyzer for Selective Hybridization (DASH): A point-of-care PCR test for rapid detection of SARS-CoV-2 infection

Effects of Different SARS-CoV-2 Testing Strategies in the Emergency Department on Length of Stay and Clinical Outcomes: A Randomised Controlled Trial

Contact Info

Product

Resources

About