scholarly journals Clinical performance of the Roche Elecsys SARS-CoV-2 Antigen fully automated electrochemiluminescence immunoassay

2021 ◽  
Author(s):  
Gian Luca Salvagno ◽  
Laura Pighi ◽  
Simone De Nitto ◽  
Giuseppe Lippi
Keyword(s):  
Sensitivity And Specificity ◽  
Clinical Performance ◽  
Area Under The Curve ◽  
Molecular Testing ◽  
Molecular Test ◽  
Rt Pcr ◽  
Antigen Concentration ◽  
Cycle Threshold ◽  
Electrochemiluminescence Immunoassay ◽  
Design And Methods

Abstract Objective: We assessed the clinical performance of novel Roche Elecsys SARS-CoV-2 Antigen fully automated electrochemiluminescence immunoassay (ECLIA). Design and Methods: We tested 160 subjects, 110 (68.8%) with positive molecular test for SARS-CoV-2 infection in nasopharyngeal samples with Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit and Roche Elecsys SARS-CoV-2 Antigen. The local imprecision was validated by analyzing three nasopharyngeal samples with different antigen concentration (1.84, 9.51 and 423.30 TCID50/mL) for 20 consecutive times (intra-assay imprecision) or for 10 consecutive working days (inter-assay imprecision).Results: The local intra- and inter-assay imprecision of Elecsys SARS-CoV-2 Antigen ECLIA was found to be comprised between 2.0-2.0% and 5.8-7.6%, yielding to a total imprecision of 6.2-7.8%. Highly significant correlation was found between Elecsys SARS-CoV-2 Antigen ECLIA and cycle threshold (Ct) values of SARS-CoV-2 S and E genes (both r=-0.91; p<0.001). The area under the curve (AUC), sensitivity and specificity of Elecsys SARS-CoV-2 Antigen ECLIA were 0.83, 0.43 and 1.00 in all samples, 0.99, 0.87 and 0.99 in those with both Ct values <30, as well as 1.00, 1.00 and 0.89 in samples with both Ct values <25. Conclusion: Roche Elecsys SARS-CoV-2 Antigen ECLIA may be a surrogate of molecular testing for identification of super-spreaders.

scholarly journals Clinical performance of the point-of-care cobas Liat for detection of SARS-CoV-2 in 20 minutes: A multicenter study

2020 ◽  
Author(s):  
Glen Hansen ◽  
Jamie Marino ◽  
Zi-Xuan Wang ◽  
Kathleen G. Beavis ◽  
John Rodrigo ◽  
...  
Keyword(s):  
Influenza A ◽  
Clinical Performance ◽  
Point Of Care ◽  
Nasopharyngeal Swab ◽  
Molecular Testing ◽  
Rt Pcr ◽  
Percent Agreement ◽  
Individual Care ◽  
Pcr Technology ◽  
Acid Test

Background: Highly accurate testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the point of care (POC) is an unmet diagnostic need in emergency care and time-sensitive outpatient care settings. Reverse transcription-polymerase chain reaction (RT-PCR) technology is the gold-standard for SARS-CoV-2 diagnostics. Methods: We performed a multi-site United States (US) study comparing the clinical performance of the first US Food and Drug Administration (FDA) authorized POC RT-PCR test for detection of SARS-CoV-2 in 20 minutes, the cobas® Liat SARS-CoV-2 & Influenza A/B nucleic acid test, to the most widely used RT-PCR laboratory test, the cobas® 68/8800 SARS-CoV-2 test. Results: Clinical nasopharyngeal swab specimens from 444 patients with 357 evaluable specimens at five US clinical laboratories were enrolled from September 21, 2020 to October 23, 2020. The overall agreement between the Liat and 68/8800 systems for SARS-CoV-2 diagnostics was 98.6% (352/357). Using Liat, positive percent agreement for SARS-CoV-2 was 100% (162/162) and the negative percent agreement was 97.4% (190/195). Conclusion: The Liat is an RT-PCR POC test that provides highly accurate SARS-CoV-2 results in 20 minutes with equivalent performance to high-throughput laboratory molecular testing. Rapid RT-PCR testing at the POC can enable more timely infection control and individual care decisions for Coronavirus Disease 2019.

scholarly journals Clinical Evaluation of the Novel Rapid Nucleic Acid Amplification Point-of-Care Test (Smart Gene SARS-CoV-2) in the analysis of Nasopharyngeal and Anterior Nasal samples.

2021 ◽  
Author(s):  
Yoshihiko Kiyasu ◽  
Masato Owaku ◽  
Yusaku Akashi ◽  
Yuto Takeuchi ◽  
Kenji Narahara ◽  
...  
Keyword(s):  
Real Time ◽  
Clinical Performance ◽  
Point Of Care ◽  
Nucleic Acid Amplification ◽  
Molecular Testing ◽  
The Novel ◽  
Rt Pcr ◽  
Pcr Assay ◽  
Point Of Care Test ◽  
Hands On

Introduction Smart Gene is a point-of-care (POC)-type automated molecular testing platform that can be performed with 1 minute of hands-on-time. Smart Gene SARS-CoV-2 is a newly developed Smart Gene molecular assay for the detection of SARS-CoV-2. The analytical and clinical performance of Smart Gene SARS-CoV-2 has not been evaluated. Methods Nasopharyngeal and anterior nasal samples were prospectively collected from subjects referred to the local PCR center from March 25 to July 5, 2021. Two swabs were simultaneously obtained for the Smart Gene SARS-CoV-2 assay and the reference real-time RT-PCR assay, and the results of Smart Gene SARS-CoV-2 were compared to the reference real-time RT-PCR assay. Results Among a total of 1150 samples, 68 of 791 nasopharyngeal samples and 51 of 359 anterior nasal samples were positive for SARS-CoV-2 in the reference real-time RT-PCR assay. In the testing of nasopharyngeal samples, Smart Gene SARS-CoV-2 showed the total, positive and negative concordance of 99.2% (95% confidence interval [CI]: 98.4–99.7%), 94.1% (95% CI: 85.6–98.4%) and 99.7% (95% CI: 99.0–100%), respectively. For anterior nasal samples, Smart Gene SARS-CoV-2 showed the total, positive and negative concordance of 98.9% (95% CI: 97.2–99.7%), 98.0% (95% CI: 89.6–100%) and 99.0% (95% CI: 97.2–99.8%), respectively. In total, 5 samples were positive in the reference real-time RT-PCR and negative in Smart Gene SARS-CoV-2, whereas 5 samples were negative in the reference real-time RT-PCR and positive in Smart Gene SARS-CoV-2. Conclusion Smart Gene SARS-CoV-2 showed sufficient analytical performance for the detection of SARS-CoV-2 in nasopharyngeal and anterior nasal samples.

scholarly journals Performance and Implementation Evaluation of the Abbott BinaxNOW Rapid Antigen Test in a High-throughput Drive-through Community Testing Site in Massachusetts

2021 ◽  
Author(s):  
Nira R. Pollock ◽  
Jesica R. Jacobs ◽  
Kristine Tran ◽  
Amber Cranston ◽  
Sita Smith ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
High Throughput ◽  
Point Of Care ◽  
High Sensitivity ◽  
High Specificity ◽  
Molecular Testing ◽  
Rt Pcr ◽  
Asymptomatic Children ◽  
Testing Site ◽  
Very High

AbstractBackgroundRapid diagnostic tests (RDTs) for SARS-CoV-2 antigens (Ag) that can be performed at point-of-care (POC) can supplement molecular testing and help mitigate the COVID-19 pandemic. Deployment of an Ag RDT requires an understanding of its operational and performance characteristics under real-world conditions and in relevant subpopulations. We evaluated the Abbott BinaxNOW™ COVID-19 Ag Card in a high-throughput, drive-through, free community testing site in Massachusetts (MA) using anterior nasal (AN) swab RT-PCR for clinical testing.MethodsIndividuals presenting for molecular testing in two of seven lanes were offered the opportunity to also receive BinaxNOW testing. Dual AN swabs were collected from symptomatic and asymptomatic children (≤ 18 years) and adults. BinaxNOW testing was performed in a testing pod with temperature/humidity monitoring. One individual performed testing and official result reporting for each test, but most tests had a second independent reading to assess inter-operator agreement. Positive BinaxNOW results were scored as faint, medium, or strong. Positive BinaxNOW results were reported to patients by phone and they were instructed to isolate pending RT-PCR results. The paired RT-PCR result was the reference for sensitivity and specificity calculations.ResultsOf 2482 participants, 1380 adults and 928 children had paired RT-PCR/BinaxNOW results and complete symptom data. 974/1380 (71%) adults and 829/928 (89%) children were asymptomatic. BinaxNOW had 96.5% (95% confidence interval [CI] 90.0-99.3) sensitivity and 100% (98.6-100.0) specificity in adults within 7 days of symptoms, and 84.6% (65.1-95.6) sensitivity and 100% (94.5-100.0) specificity in children within 7 days of symptoms. Sensitivity and specificity in asymptomatic adults were 70.2% (56.6-81.6) and 99.6% (98.9-99.9), respectively, and in asymptomatic children were 65.4% (55.6-74.4) and 99.0% (98.0-99.6), respectively. By cycle threshold (Ct) value cutoff, sensitivity in all subgroups combined (n=292 RT-PCR-positive individuals) was 99.3% with Ct ≤25, 95.8% with ≤30, and 81.2% with ≤35. Twelve false positive BinaxNOW results (out of 2308 tests) were observed; in all twelve, the test bands were faint but otherwise normal, and were noted by both readers. One invalid BinaxNOW result was identified. Inter-operator agreement (positive versus negative BinaxNOW result) was 100% (n = 2230/2230 double reads). Each operator was able to process 20 RDTs per hour. In a separate set of 30 specimens (from individuals with symptoms ≤7 days) run at temperatures below the manufacturer’s recommended range (46-58.5°F), sensitivity was 66.7% and specificity 95.2%.ConclusionsBinaxNOW had very high specificity in both adults and children and very high sensitivity in newly symptomatic adults. Overall, 95.8% sensitivity was observed with Ct ≤ 30. These data support public health recommendations for use of the BinaxNOW test in adults with symptoms for ≤7 days without RT-PCR confirmation. Excellent inter-operator agreement indicates that an individual can perform and read the BinaxNOW test alone. A skilled laboratorian can perform and read 20 tests per hour. Careful attention to temperature is critical.

scholarly journals Clinical Evaluation of a Combo Rapid Antigen Test QuickNavi-Flu+COVID19 Ag for Simultaneous Detection of SARS-CoV-2 and Influenza Viruses

2021 ◽  
Author(s):  
Yuto Takeuchi ◽  
Yusaku Akashi ◽  
Yoshihiko Kiyasu ◽  
Norihiko Terada ◽  
Yoko Kurihara ◽  
...  
Keyword(s):  
Real Time ◽  
Sensitivity And Specificity ◽  
Clinical Performance ◽  
Simultaneous Detection ◽  
Influenza Viruses ◽  
Antigen Test ◽  
Sample Collection ◽  
Rt Pcr ◽  
The Real ◽  
Reverse Transcription Pcr

AbstractIntroductionSince respiratory sample collection is an uncomfortable experience, simultaneous detection of pathogens with a single swab is preferable. We prospectively evaluated the clinical performance of a newly developed antigen test QuickNavi-Flu+COVID19 Ag (Denka Co., Ltd., Tokyo, Japan) which can detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza viruses at the same time with a single testing device.MethodsIncluded were those who were suspected of contracting coronavirus disease 2019 (COVID-19) and referred to a PCR center at Ibaraki prefecture in Japan, between August 2, 2021 to September 13, 2021, when the L452R mutant strains of SARS-CoV-2 were prevalent. Additional nasopharyngeal samples and anterior nasal samples were obtained for the antigen test and were compared with a reference reverse transcription PCR (RT-PCR) using nasopharyngeal samples.ResultsIn total, 1510 nasopharyngeal samples and 862 anterior nasal samples were evaluated. For SARS-CoV-2 detection in nasopharyngeal samples, the sensitivity and specificity of the antigen test were 80.9% and 99.8%, respectively. The sensitivity and specificity using anterior nasal samples were 67.8% and 100%, respectively. In symptomatic cases, the sensitivities increased to 88.3% with nasopharyngeal samples and 73.7% with anterior nasal samples. There were three cases of discrepant results between the antigen test and the real-time RT-PCR. All of them were positive with the antigen test but negative with the real-time RT-PCR in SARS-CoV-2 detection. During the study period, influenza viruses were not detected.ConclusionA combo kit, QuickNavi-Flu+COVID19 Ag, showed an acceptable sensitivity and sufficient specificity for SARS-CoV-2 detection, especially using nasopharyngeal sample collected from symptomatic patients.

scholarly journals Predictive molecular pathology in the time of coronavirus disease (COVID-19) in Europe

2020 ◽  
pp. jclinpath-2020-206957 ◽  
Author(s):  
Umberto Malapelle ◽  
Pasquale Pisapia ◽  
Antonino Iaccarino ◽  
Massimo Barberis ◽  
Claudio Bellevicine ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Liquid Biopsy ◽  
Predictive Biomarker ◽  
Turnaround Time ◽  
Molecular Testing ◽  
Advanced Stage ◽  
Molecular Test ◽  
Rt Pcr ◽  
Molecular Tests ◽  
Advanced Stage Lung Cancer

AimsLung cancer predictive biomarker testing is essential to select advanced-stage patients for targeted treatments and should be carried out without delays even during health emergencies, such as the coronavirus (COVID-19) outbreak.MethodsFifteen molecular laboratories from seven different European countries compared 4 weeks of national lockdown to a corresponding period in 2019, in terms of tissue and/or plasma-based molecular test workload, analytical platforms adopted, number of cases undergoing programmed death-ligand1 (PD-L1) expression assessment and DNA-based molecular tests turnaround time.ResultsIn most laboratories (80.0%), tissue-based molecular test workload was reduced. In 40.0% of laboratories (6/15), the decrease was >25%, and in one, reduction was as high as 80.0%. In this instance, a concomitant increase in liquid biopsy was reported (60.0%). Remarkably, in 33.3% of the laboratories, real-time PCR (RT-PCR)-based methodologies increased, whereas highly multiplexing assays approaches decreased. Most laboratories (88.9%) did not report significant variations in PD-L1 volume testing.ConclusionsThe workload of molecular testing for patients with advanced-stage lung cancer during the lockdown showed little variations. Local strategies to overcome health emergency-related issues included the preference for RT-PCR tissue-based testing methodologies and, occasionally, for liquid biopsy.

scholarly journals Use of immunohistochemistry for detection of Epidermal growth factor receptor mutation status in lung adenocarcinoma

2020 ◽  
Vol 10 (2) ◽  
pp. 1706-1710
Author(s):  
Niharika Shah ◽  
Helmut Popper ◽  
Smriti Karki ◽  
Deebya Raj Mishra
Keyword(s):  
Targeted Therapy ◽  
Lung Adenocarcinoma ◽  
Sensitivity And Specificity ◽  
Egfr Mutation ◽  
Growth Factor Receptor ◽  
Antibody Test ◽  
Molecular Testing ◽  
Molecular Test ◽  
Positive Antibody ◽  
Exon 19 Deletion

Background: Since the advent of targeted therapy in lung cancer, in settings where it is not possible to send for molecular testing of lung adenocarcinoma, immunohistochemistry for EGFR mutation-specific antibodies can be used as an alternative for detection of EGFR mutation. Materials and methods: 50 lung adenocarcinoma cases were screened at the Medical University of Graz. 19 cases in which molecular test as well as immunohistochemistry were positive for EGFR mutation. Cases where immunohistochemistry results and molecular test for the E-746-A750 deletion and the L858 mutation were positive, were considered true positives. Similarly, false positives, true negatives, and false negatives were determined. Results: The mean age of the patients was 78.6 yrs. Among 19 cases, 7 were positive for E-746-A750 deletion (7/19, 36%), among which 4 cases also showed positivity with IHC. 4 were positive for the L858 mutation (4/19, 21%), among which 3 also showed positivity with immunohistochemistry. The rest of the 8 cases were positive for EGFR mutation in other loci. The sensitivity and specificity of the immunohistochemistry test of antibody specific to E-746-A750 exon 19 deletion was 100% and 80% respectively. The sensitivity and specificity of the IHC test of Ab specific to L858 mutation was 75%, and 100% respectively. Conclusions: Our results have been comparable to previous studies. However, our sample size was a limitation. It can still be concluded that immunohistochemistry can be a diagnostic option in low resource settings, and can aid in ensuring that patients with a positive antibody test get targeted therapy.

scholarly journals Accuracy of deep learning based computed tomography diagnostic system of COVID-19: a consecutive sampling external validation cohort study

2020 ◽  
Author(s):  
Tatsuyoshi Ikenoue ◽  
Yuki Kataoka ◽  
Yoshinori Matsuoka ◽  
Junichi Matsumoto ◽  
Junji Kumasawa ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Cohort Study ◽  
Sensitivity And Specificity ◽  
Goodness Of Fit ◽  
Tertiary Care ◽  
External Validation ◽  
Area Under The Curve ◽  
Chest Ct ◽  
List Type ◽  
Rt Pcr

AbstractObjectivesAli-M3, an artificial intelligence, analyses chest computed tomography (CT) and detects the likelihood of coronavirus disease (COVID-19) in the range of 0 to 1. It demonstrates excellent performance for the detection of COVID-19 patients with a sensitivity and specificity of 98.5 and 99.2%, respectively. However, Ali-M3 has not been externally validated. Our purpose is to evaluate the external validity of Ali-M3 using Japanese sequential sampling data.MethodsIn this retrospective cohort study, COVID-19 infection probabilities were calculated using Ali-M3 in 617 symptomatic patients who underwent reverse transcription-polymerase chain reaction (RT-PCR) tests and chest CT for COVID-19 diagnosis at 11 Japanese tertiary care facilities, between January 1 and April 15, 2020.ResultsOf 617 patients, 289 patients (46.8%) were RT-PCR-positive. The area under the curve (AUC) of Ali-M3 for predicting a COVID-19 diagnosis was 0.797 (95% confidence intervals [CI]: 0.762-0.833) and goodness-of-fit was P = 0.156. With a cut-off of probability of COVID-19 by Ali-M3 diagnosis set at 0.5, the sensitivity and specificity were 80.6% and 68.3%, respectively, while a cut-off of 0.2 yielded a sensitivity and specificity of 89.2% and 43.2%, respectively. Among 223 patients who required oxygen support, the AUC was 0.825 and sensitivity at a cut-off of 0.5 and 0.2 were 88.7% and 97.9%, respectively. Although the sensitivity was lower when the days from symptom onset were few, sensitivity increased for both cut-off values after 5 days.ConclusionsAli-M3 was evaluated by external validation and shown to be useful to exclude a diagnosis of COVID-19.Key PointsThe area under the curve (AUC) of Ali-M3, which is an AI system for diagnosis of COVID-19 based on chest CT images, was 0.797 and goodness-of-fit was P = 0.156.With a cut-off of probability of COVID-19 by Ali-M3 diagnosis set at 0.5, the sensitivity and specificity were 80.6% and 68.3%, respectively, while a cut-off of 0.2 yielded 89.2% and 43.2%.Although low sensitivity was observed in less number of days from symptoms onset, after 5 days high increasing sensitivity was observed. In patients requiring oxygen support, the AUC was higher that is 0.825.

scholarly journals Multi-site clinical validation of Isothermal Amplification based SARS-COV-2 detection assays using different sampling strategies

2021 ◽  
Author(s):  
Kanan T Desai ◽  
Karla Alfaro ◽  
Laura Mendoza ◽  
Matthew Faron ◽  
Brian Mesich ◽  
...  
Keyword(s):  
Viral Load ◽  
Sensitivity And Specificity ◽  
Clinical Performance ◽  
Low Cost ◽  
Isothermal Amplification ◽  
Detection Methods ◽  
Clinical Validation ◽  
Sampling Strategies ◽  
Rt Pcr ◽  
Study Sites

Background: Isothermal amplification-based tests were developed as rapid, low-cost, and simple alternatives to real-time reverse transcriptase-polymerase chain reaction (RT-PCR) tests for SARS-COV-2 detection. Methods: Clinical performance of two isothermal amplification-based tests (Atila Biosystems iAMP COVID-19 detection test and OptiGene COVID-19 Direct Plus RT-LAMP test) was compared to clinical RT-PCR assays using different sampling strategies. A total of 1378 participants were tested across four study sites. Results: Compared to standard of care RT-PCR testing, the overall sensitivity and specificity of the Atila iAMP test for detection of SARS-CoV-2 were 76.2% and 94.9%, respectively, and increased to 88.8% and 89.5%, respectively, after exclusion of an outlier study site. Sensitivity varied based on the anatomic collected site. Sensitivity for nasopharyngeal was 65.4% (range across study sites:52.8%-79.8%), mid-turbinate 88.2%, saliva 55.1% (range across study sites:42.9%-77.8%) and anterior nares 66.7% (range across study sites:63.6%-76.5%). The specificity for these anatomic collection sites ranged from 96.7% to 100%. Sensitivity improved in symptomatic patients (overall 82.7%) and those with a higher viral load (overall 92.4% for ct≤25). Sensitivity and specificity of the OptiGene Direct Plus RT-LAMP test, conducted at a single study-site, were 25.5% and 100%, respectively. Conclusions The Atila iAMP COVID test with mid-turbinate sampling is a rapid, low-cost assay for detecting SARS-COV-2, especially in symptomatic patients and those with a high viral load, and could be used to reduce the risk of SARS-COV-2 transmission in clinical settings. Variation of performance between study sites highlights the need for site-specific clinical validation of these assays before clinical adoption.

HPV self-sampling in CIN2+ detection: sensitivity and specificity of different RLU cut-off of HC2 in specimens from 786 women

2016 ◽  
Vol 70 (4) ◽  
pp. 327-330
Author(s):  
F Bottari ◽  
S Igidbashian ◽  
S Boveri ◽  
A Tricca ◽  
C Gulmini ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Low Income ◽  
Clinical Performance ◽  
Area Under The Curve ◽  
Intraepithelial Neoplasia ◽  
Screening Strategy ◽  
Detection Sensitivity ◽  
Low Income Countries ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Hpv Test

AimsMortality for cervical cancer varies between the different regions of the world, with high rates in low-income countries where screening programmes are not present and organised. However, increasing screening coverage is still a priority in all countries: one way to do that is to base screening on self-sampled screening. The success of a self-sampling screening strategy depends on capacity to recruit unscreened women, on the performance and acceptability of the device and on the clinical performance of the high-risk human papillomavirus (HPV) test.MethodsThis study based on 786 enrolled women investigates the best cut-off value of Hybrid Capture 2 HPV test (HC2) for self-sampled specimens in terms of sensitivity and specificity.ResultsIn this population, we found that the sensitivity and the specificity for cervical intraepithelial neoplasia grade 2 or more detection of HC2 performed on self-sampled specimens were 82.5% and 82.8%, respectively considering the relative light units (RLU) cut-off value of 1. Increasing the cut-off value the sensitivity decreases and the specificity raises and the best area under the curve for the RLU cut-off value is 1.ConclusionsOur results confirm that the cut-off value of 1 suggested by Qiagen for PreservCyt specimen is the best cut-off value also for self-sampled specimens.

scholarly journals CLINICAL PERFORMANCE OF THE CALL SCORE FOR THE PREDICTION OF ADMISSION TO ICU AND DEATH IN HOSPITALIZED PATIENTS WITH COVID-19 PNEUMONIA IN A REFERENCE HOSPITAL IN PERU

2021 ◽  
Author(s):  
Rafael Pichardo-Rodriguez ◽  
Marcos Saavedra-Velasco ◽  
Willy Peña-Oscuvilca ◽  
Jhonnathan Ascarza-Saldaña ◽  
Cesar Sanchez-Alvarez ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Area Under The Curve ◽  
Risk Groups ◽  
Molecular Testing ◽  
Cross Sectional ◽  
Icu Admission ◽  
Hospital Patients ◽  
Reference Hospital ◽  
Low Performance ◽  
Sensitivity Specificity

ABSTRACTObjectiveDetermine the CALL SCORE’s diagnostic accuracy for the prediction of ICU admission and death in patients hospitalized for COVID-19 pneumonia in a reference hospital in Peru.MethodsWe performed an analytical cross-sectional observational study. We included patients with COVID-19 pneumonia treated at the “Dos de Mayo” National Hospital. Patients over 18 years old with a diagnosis confirmed by rapid or molecular testing were included. Those with an incomplete, illegible, or missing medical history and/or bacterial or fungal pneumonia were excluded. Data were extracted from medical records. The primary outcomes were mortality and admission to the ICU. The Call Score was calculated for each patient (4 to 13 points) and classified into three risk groups. Summary measures were presented for qualitative and quantitative variables. The area under the model curve and the operational characteristics (sensitivity, specificity) were calculated for the best cut-off point.ResultsThe Call Score reported an area under the curve of 0.59 (IC95%: 0.3 to 0.07), p = 0.43 for predicting death. However, for a cut-off point of 5.5, a sensitivity of 87%and a specificity of 65%were obtained. The area under the curve for ICU admission was 0.67 (95%CI: 0.3 to 0.07), p = 0.43; the 5.5 cut-off point showed a sensitivity of 82%and a specificity of 51%.ConclusionsThe Call Score shows a low performance for predicting mortality and admission to the ICU in Peruvian patients.

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