scholarly journals SARS-CoV-2 Antigen Detection to Expand Testing Capacity for COVID-19: Results from a Hospital Emergency Department Testing Site

Diagnostics ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 1211
Author(s):  
Giulia Menchinelli ◽  
Giulia De Angelis ◽  
Margherita Cacaci ◽  
Flora Marzia Liotti ◽  
Marcello Candelli ◽  
...  

Background: SARS-CoV-2 antigen detection has currently expanded the testing capacity for COVID-19, which yet relies on the SARS-CoV-2 RNA RT-PCR amplification. Objectives: To report on a COVID-19 testing algorithm from a tertiary care hospital emergency department (ED) that combines both antigen (performed on the ED) and RT-PCR (performed outside the ED) testing. Methods: Between December 2020 and January 2021, in a priori designated, spatially separated COVID-19 or non-COVID-19 ED areas, respectively, symptomatic or asymptomatic patients received SARS-CoV-2 antigen testing on nasopharyngeal swab samples. Antigen results were promptly accessible to guide subsequent, outside performed confirmatory (RT-PCR) testing. Results: Overall, 1083 (100%) of 1083 samples in the COVID-19 area and 1815 (49.4%) of 3670 samples in the non-COVID-19 area had antigen results that required confirmation by RT-PCR. Antigen positivity rates were 12.4% (134/1083) and 3.7% (66/1815), respectively. Compared to RT-PCR testing results, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of antigen testing were, respectively, 68.0%, 98.3%, 88.8%, and 94.1% in the COVID-19 area, and 41.9%, 97.3%, 27.3%, and 98.6% in non-COVID-19 area. Practically, RT-PCR tests were avoided in 50.6% (1855/3670) of non-COVID-19 area samples (all antigen negative) from patients who, otherwise, would have needed antigen result confirmation. Conclusions: Our algorithm had value to preserve RT-PCR from avoidable usage and, importantly, to save time, which translated into a timely RT-PCR result availability in the COVID-19 area.

2021 ◽  
Vol 11 (3) ◽  
pp. 95-100
Author(s):  
Majid Alsalamah ◽  
Nesreen Suliman Alwallan ◽  
Saeed Mastour Alshahrani ◽  
Bader F Al-Khateeb ◽  
Raed Aldahash ◽  
...  

Author(s):  
Harika Vangara ◽  
Usha Kalawat ◽  
B Siddhartha Kumar ◽  
Manohar Badur ◽  
Mukkara Madhusudan ◽  
...  

Introduction: Rapid antigen testing can help in early diagnosis of Influenza in resource limited settings in patients presenting with Influenza Like Illness (ILI). Aim: To evaluate the usefulness of Rapid Influenza Direct antigen Testing (RIDT) in comparison to Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) for diagnosis of Influenza virus infection in clinically suspected patients with ILI in a tertiary care hospital. Material and Methods: A prospective observational independent study was done to evaluate RIDT for Influenza virus infection, considering RT-PCR as gold standard. Throat swabs and nasal swabs from patients meeting Category 3 definition of ILI by Ministry Of Health and Family Welfare (MOHFW) were collected from July 20th, 2019 to October 20th, 2019 from hospitals in and around the study area. Onsite Rapid test (Biogenix, China) was used as per manufactures instructions for rapid detection of Influenza antigen. RNA extraction was done using Qiagen kit followed by RT-PCR using primer, probes recommended by National Institute of Virology (NIV, Pune) as per their protocols. Data was recorded on a predesigned proforma and managed using Microsoft Excel 2018 (Microsoft Corp, Redmond, WA). The Statistical software MedCalc version 9.1 for Windows was used for data analysis. Results: The overall sensitivity of the RIDT was 37.9% and specificity was 94.4%. The Positive Predictive Value (PPV) and Negative Predictive Value (NPV) were 73.3% and 78.8%, respectively. Kappa was calculated to be 0.37 that suggested a fair agreement between RIDT and RT-PCR. When the Cycle threshold (Ct) values were compared to the results of RIDT, there were more false positives at low Ct value and more false negatives at high Ct values. Conclusion: The RIDT is not useful in screening during an outbreak in acute care settings. The negative result of RIDT should be followed up with RT-PCR. With a strong clinical suspicion, it is better to start antivirals than wait for laboratory report in severely ill patients with ILI.


2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Daniela Loconsole ◽  
Francesca Centrone ◽  
Caterina Morcavallo ◽  
Silvia Campanella ◽  
Anna Sallustio ◽  
...  

Background. In emergency hospital settings, rapid diagnosis and isolation of SARS-CoV-2 patients are required. The aim of the study was to evaluate the performance of an antigen chemiluminescence enzymatic immunoassay (CLEIA) and compare it with that of Real-time Reverse transcription-Polymerase Chain Reaction (RT-qPCR), the gold standard assay, to assess its suitability as a rapid diagnostic method for managing patients in the emergency department (ED). Methods. Consecutive patients with no previous history of SARS-CoV-2 infection attending the ED of the Policlinico Hospital of Bari between 23rd October and 4th November 2020 were enrolled. Clinical and demographic data were collected for all patients. Nasopharyngeal swabs collected on admission were subjected both to molecular (RT-qPCR) and antigen (CLEIA) tests for SARS-CoV-2. The performance of the CLEIA antigen test was analyzed using R Studio software and Microsoft Excel. Receiver operating characteristics were also performed. Results. A total of 911 patients were enrolled, of whom 469 (51.5%) were male. Of the whole cohort, 23.7% tested positive for SARS-CoV-2 by RT-qPCR and 24.5% by CLEIA. The overall concordance rate was 96.8%. The sensitivity, specificity, positive predictive value, and negative predictive value of the antigen test were 94.9% (95% CI, 91.9–97.0), 97.4% (95% CI, 96.5–98.1), 91.9% (95% CI, 89.0–94.0), and 98.4% (95% CI, 97.4–99.1), respectively. The area under the curve (AUC) was 0.99. The kappa coefficient was 0.91. The overall positive and negative likelihood ratios were 37 (95% CI 23-58) and 0.05 (95% CI, 0.03–0.09), respectively. Conclusions. Data analysis demonstrated that the antigen test showed very good accuracy for discriminating SARS-CoV-2-infected patients from negative participants. The CLEIA is suitable for rapid clinical diagnosis of patients in hospital settings, particularly in EDs with a high prevalence of symptomatic patients and where a rapid turnaround time is critical. Timely and accurate testing for SARS-CoV-2 plays a crucial role in limiting the spread of the virus.


2020 ◽  
Vol 8 (S1) ◽  
pp. 33-40
Author(s):  
Banerjee J ◽  
Reddy SG ◽  
Darapuneni RC ◽  
Bilolikar AK

Introduction: December 2019, witnessed the emergence of a novel coronavirus in human population. Later named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has since spread across the globe and results into coronavirus disease 2019 (COVID-19) pandemic. Objective: The objective of this study was to evaluate COVID-19 infection positivity rate, its age and gender wise prevalence and to compare the results of rapid antigen detection test with gold standard real time RT-PCR for early detection of SARS-CoV-2 virus. Methods: An observational study was conducted in the Department of Microbiology and Molecular Biology of Krishna Institute of Medical Sciences, Secunderabad, Telangana. Results: A total of 208 patients’ specimens (nasopharyngeal swab) were compared within a period of one and half month. Infection positivity rate was observed as 26.92% (n=56). Our study revealed that among all 56 COVID-19 positive patients, 60.71% (n=34) were symptomatic whereas 39.2% (n=22) were asymptomatic. Conclusion: We conclude that after comparing with real time RT-PCR, antigen detection assay is not as sensitive as molecular test especially during the early stages of infection but this has potential to become an important tool for mass screening for COVID-19 and can be considered as fast and economic diagnostic tools in the remote areas where the laboratory facilities for molecular tests are not accessible. Keywords: COVID-19; pandemic; nasopharyngeal swab; rapid antigen detection assay; real time RT-PCR


CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S21-S21
Author(s):  
A. Verma ◽  
I. Cheng ◽  
K. Pardhan ◽  
L. Notario ◽  
W. Thomas-Boaz ◽  
...  

Background: Increasing Emergency Department (ED) stretcher occupancy with admitted patients at our tertiary care hospital has contributed to long Physician Initial Assessment (PIA) times. As of Oct 2019, median PIA was 2.3 hours and 90th percentile PIA was 5.3 hours, with a consequent 71/74 PIA ranking compared to all Ontario EDs. Ambulatory zone (AZ) models are more commonly used in community EDs compared to tertiary level EDs. An interdisciplinary team trialled an AZ model for five days in our ED to improve PIA times. Aim Statement: We sought to decrease the median PIA for patients in our ED during the AZ trial period as compared to days with similar occupancy and volume. Measures & Design: The AZ was reserved for patients who could walk from a chair to stretcher. In this zone, ED rooms with stretchers were for patient assessment only; when waiting for results or receiving treatment, patients were moved into chairs. We removed nursing assignment ratios to increase patient flow. Our outcome measure was the median PIA for all patients in our ED. Our balancing measure was the 90th percentile PIA, which could increase if we negatively impacted patients who require stretchers. The median and 90th percentile PIA during the AZ trial were compared to similar occupancy and volume days without the AZ. Additional measures included ED Length of Stay (LOS) for non-admitted patients, and patients who leave without being seen (LWBS). Clinicians and patients provided qualitative feedback through surveys. Evaluation/Results: The median PIA during the AZ trial was 1.5 hours, compared to 2.1 hours during control days. Our balancing measure, the 90th percentile PIA was 3.7 hours, compared to 5.0 during control days. A run chart revealed both median and 90th percentile PIA during the trial were at their lowest points over the past 18 months. The number of LWBS patients decreased during the trial; EDLOS did not change. The majority of patients, nurses, and physicians felt the trial could be implemented permanently. Discussion/Impact: Although our highly specialized tertiary care hospital faces unique challenges and high occupancy pressures, a community-hospital style AZ model was successful in improving PIA. Shorter PIA times can improve other quality metrics, such as timeliness of analgesia and antibiotics. We are working to optimize the model based on feedback before we cycle another trial. Our findings suggest that other tertiary care EDs should consider similar AZ models.


2021 ◽  
Author(s):  
Sunil S Solomon ◽  
Yu-Hsiang Hsieh ◽  
Richard E Rothman ◽  
Oliver Laeyendecker ◽  
Shruti H Mehta ◽  
...  

While COVID-19 vaccines have been shown to significantly decrease morbidity and mortality, there is still much debate about optimal strategies of vaccine rollout. We tested identity-unlinked stored remnant blood specimens of patients at least 18 years presenting to the Johns Hopkins Hospital emergency department (ED) between May to November 2020 for IgG to SARS-CoV-2. Data on SARS-CoV-2 RT PCR were available for patients who were tested due to suspected infection. SARS-CoV-2 infections was defined as either a positive IgG and/or RT-PCR. SARS-CoV-2 infection clustering by zipcode was analyzed by spatial analysis using the Bernoulli model (SaTScan software, Version 9.7). Median age of the 7,461 unique patients visiting the ED was 47 years and 50.8% were female; overall, 740 (9.9%) unique patients had evidence of SARS-CoV-2 infection. Prevalence of infection in ED patients by ZIP code ranged from 4.1% to 22.3%. The observed number of cases in ZIP code C was nearly double the expected (observed/expected ratio = 1.99; 95% CI: 1.62, 2.42). These data suggest a targeted geospatial approach to COVID vaccination should be considered to maximize vaccine rollout efficiency and include high-risk populations that may otherwise be subjected to delays, or missed.


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