scholarly journals Diagnostic Indexes of a Rapid IgG/IgM Combined Antibody Test for SARS-CoV-2

2020 ◽  
Author(s):  
Liu Ying ◽  
Liu Yue-ping ◽  
Diao Bo ◽  
Ren Feifei ◽  
Wang Yue ◽  
...  
Keyword(s):  
Predictive Value ◽  
Antibody Test ◽  
Turnaround Time ◽  
Ease Of Use ◽  
Sample Collection ◽  
Rt Pcr ◽  
Illness Onset ◽  
Test Kit ◽  
Combined Test ◽  
Sensitivity Specificity

[Abstract]ObjectiveCoronavirus disease 2019 (COVID-19) has become pandemic in the world. The need for IgG-IgM combined antibody test is booming, but data on diagnostic indexes evaluation was inadequate. The aim of this study was to evaluate diagnostic indexes of a rapid IgG-IgM combined antibody test for SARS-CoV-2.MethodsA total of 179 patients were enrolled. Serum were collected for IgG-IgM combined antibody test and corresponding nasal and pharyngeal swab specimens were collected for SARS-CoV-2 RT-PCR. According to SARS-CoV-2 RT-PCR results, patients under study were categorized as PCR positive group in 90 patients and PCR negative group in 89 patients.Results1. Of the 90 PCR positive samples, 77 were tested positive by SARS-CoV-2 IgG-IgM test kit, yielding a sensitivity of 85.6%. Meanwhile, of the 89 PCR negative sample, 8 samples were detected positive, resulting in a specificity of 91%. Positive predictive value, negative predictive value and accuracy of this test kit was 95.1%, 82.7%, and 88.3%, respectively. Kappa efficiency between IgG/IgM test kit and RT-PCR were 0.75. 2. Accuracy in mild/common and severe/critical subgroup were 73.9% and 97.7%, respectively. Accuracy in clinical confirmed, suspected cases and other disease subgroups were 70%, 60%, and 100%, respectively. 3. Patients were further divided into ‘0 - 7’, ‘8 - 15’ and ‘>= 16’ groups according to the time from illness onset to sample collection. Sensitivity, specificity and accuracy in these three groups were 18.8%, 77.8% and 40%; 100%, 50% and 87.5%; 100%, 64.3%, and 93.9, respectively.ConclusionThe sensitivity and specificity of this ease-of-use IgG/IgM combined test kit were adequate, plus short turnaround time, no specific requirements for additional equipment or skilled technicians, all of these collectively contributed to its competence for mass testing. At the current stage, it cannot take the place of SARA-CoV-2 nucleic acid RT-PCR, but can be served as a complementary option for RT-PCR. The combination of RT-PCR and IgG-IgM combined test kit could provide further insight into SARS-CoV-2 infection diagnosis.

scholarly journals Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar

2021 ◽  
Author(s):  
Jesha Mundodan ◽  
Samina Hasnain ◽  
Hayat Khogali ◽  
Soha Shawqi Al Bayat ◽  
Dina Ali ◽  
...  
Keyword(s):  
Predictive Value ◽  
Local Population ◽  
Rapid Test ◽  
Antibody Test ◽  
Molecular Testing ◽  
Rt Pcr ◽  
Test Kit ◽  
Asymptomatic Individuals ◽  
Sensitivity Specificity ◽  
Rapid Antibody

Background: In response to the growing coronavirus disease 2019 (COVID-19) pandemic and the shortage of laboratory based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed rapid and easy to use devices to facilitate testing outside laboratory settings. These kits are either based on detection of proteins from SARS-CoV-2 virus or detection of antigen or human antibodies generated in response to the infection. However, it is important to understand their performance characteristics and they must be validated in the local population setting.Design and Methods: The objective is to assess the validity of the rapid test for IgG and IgM immunoglobulins compared to the current gold standard reverse transcription polymerase chain reaction (RT-PCR) test. A total of 16951 asymptomatic individuals were tested by the Ministry of Public Health track-and-trace team using both rapid immunodiagnostic test and RT-PCR as part of screening across various random settings with potential risk of community interaction prior to gradual lifting of restrictions in Qatar.  Rapid test was considered to be posiive if both IgG and IgM are positive, while only IgG/IgM positive was considered as rapid test negative. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated.Results: The sensitivity of rapid test kit was found to be 0.9%, whereas the specificity was found to be 97.8%. the PPV was found to be 0.3% whereas the NPV was found to be 99.4%.Conclusion: Based on the outcome and results of the study, it appears that the sensitivity and PPV of the rapid antibody test are low. As such, this test is not recommended for use to assist in taking clinic-based decisions or decisions related to quarantine/isolation.

scholarly journals Field Evaluation of Calypte’s AWARETM Blood Serum Plasma (BSP) and Oral Mucosal Transudate (OMT) Rapid Tests for Detecting Antibodies to HIV-1 and 2 in Plasma and Oral Fluid

2009 ◽  
Vol 3 (1) ◽  
pp. 14-18 ◽  
Author(s):  
George A Alemnji ◽  
Gisele A Ngulefac ◽  
Peter M Ndumbe ◽  
Tazoacha Asonganyi
Keyword(s):  
Blood Serum ◽  
Predictive Value ◽  
Rapid Test ◽  
Field Evaluation ◽  
Ease Of Use ◽  
Test Kit ◽  
Rapid Tests ◽  
Sensitivity Specificity ◽  
Mean Cost ◽  
Hiv 1

As programs to prevent and care for HIV-infected persons are scaled-up in Africa, there is the need for continuous evaluation of the performance of test kits that could best support these programs. The present study evaluated the sensitivity, specificity, ease of use, and cost of AWARE TM Blood Serum Plasma (BSP) and Oral Mucosal Transudate (OMT) Rapid HIV-1/2 test kits using real-time and archived samples of HIV-infected persons from Cameroon. Matched whole blood and OMT specimens were collected prospectively from HIV-positive and HIV-negative persons from different regions of Cameroon and tested using the AWARE TM BSP and OMT test kits, respectively. These results were compared to the gold standard that included a combination of Determine HIV-1/2 and Enzygnost HIV-1/2. The BSP Rapid test kit was further evaluated using well characterized panels of HIV-2 and HIV-1 group O samples. Cost and end-user analysis of the OMT test kit was done by comparing its actual cost, consumables, safety, bench time and manipulation with other test kits. Of the 732 matched samples, 412 (56.3%) and 320 (43.7%) were from females and males, respectively. Of these samples, 23 (3.1%) gave discordant results between Determine HIV-1/2 and Enzygnost HIV1/2 and were excluded from the analysis. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AWARETM BSP were 100%. The AWARETM OMT had 98.8% sensitivity, 98.9% specificity, 98.0% PPV and 99.4% NPV. The results of a well-characterized archived panel of HIV-2 (n=7) and HIV-1 group O (n=3) samples using the AWARETM BSP Rapid test kit gave 100% concordance. Total per patient cost of the AWARE OMT rapid test kit was US$4.72 compared to a mean cost of US $7.33 + 0.11 for the other test kits. Both the AWARETM BSP and OMT Rapid test kits demonstrated high sensitivities and specificities on all samples tested and were well adapted for use in resource-constrained settings with high HIV heterogeneity such as Cameroon. The AWARE TM HIV-1/2 OMT Rapid test kit appears to be the cheapest, safest and easiest to use compared with other available test kits.

Evaluation of a Rapid Immunochromatographic test kit to the Gold Standard Fluorescent Antibody test for diagnosis of rabies in animals in Bhutan 

2020 ◽  
Author(s):  
Tenzin Tenzin ◽  
Kelzang Lhamo ◽  
Purna B Rai ◽  
Dawa Tshering ◽  
Pema Jamtsho ◽  
...  
Keyword(s):  
Predictive Value ◽  
Fluorescent Antibody ◽  
False Negative ◽  
Rapid Test ◽  
Antibody Test ◽  
Reference Standard ◽  
Predictive Values ◽  
Percent Agreement ◽  
Test Kit ◽  
Resource Poor

Abstract Background: Rabies kills approximately 59,000 people in the world each year worldwide. Rapid and accurate diagnosis of rabies is important for instituting rapid containment measures and for advising the exposed people for postexposure treatment. The application of a rapid diagnostic tests in the field can greatly enhance disease surveillance and diagnostic activities, especially in resource poor settings. In this study, a total of 179 brain tissue samples collected from different rabies suspect animal species (113 dogs, 50 cattle, 10 cats, 3 goats, 2 horses, and 1 bear) were selected and tested using both rapid immunochromatographic kit and the reference standard fluorescent antibody test (FAT). We evaluated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of a rapid antigen detection test kit produced by BioNote, Inc. (Hwaseong-si, Korea) relative to a FAT for its fit-for-purpose for confirmation of clinical cases of rabies for early response and enhancing rabies surveillance. Results: Among 179 samples examined in this study, there was a concordance in results by the rapid test and FAT in 115 positive samples and 54 negative samples. Test results were discordant in 10 samples which were positive by FAT, but negative (false negative) by rapid kit. The rapid test kit showed a sensitivity of 92% (95% CI: 85.9 – 95.6) and specificity of 100% (95% CI: 93.4 – 100) using FAT as the reference standard. The positive and negative predictive values were found to be 100% (95% CI:96.7 – 100) and 84.4% (95% CI: 73.6 – 91.3), respectively. Overall, there was 94.4% (95% CI: 90 – 96.9) test agreement between rapid test and FAT (Kappa value = 0.874) with a positive percent agreement and negative percent agreement of 92 and 100%, respectively. Conclusions: Our finding demonstrated that the rapid test kit (BioNote) can be used for rabies surveillance and confirming clinical case of rabies in animals for making rapid decisions particularly controlling rabies outbreaks in resource poor settings.

scholarly journals SAT-422 Evaluation of the Siemens Thyroid Stimulating Immunoglobulin (TSI) Assay for Diagnosis and Prognosis of Graves’ Disease

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Heather Paul ◽  
Nadia Moledina ◽  
Jason Robinson ◽  
Alex Chin ◽  
Gregory A Kline ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Predictive Value ◽  
False Negative ◽  
Thyroid Stimulating Hormone ◽  
Clinical Findings ◽  
Graves Disease ◽  
Sample Collection ◽  
Primary Analysis ◽  
Sensitivity Specificity ◽  
Stimulating Hormone

Abstract Background: Hyperthyroidism due to Graves’ disease (GD) is an autoimmune condition caused by thyroid stimulating hormone receptor (TSHR) autoantibodies. Autoantibodies to the TSHR can stimulate or block thyroid hormone production, therefore testing specifically for stimulating antibodies would be beneficial for diagnosis of GD. Objectives: The primary objective of the first phase of this trial is to assess the diagnostic capability of the Siemens Thyroid Stimulating Immunoglobulin (TSI) immunoassay in diagnosing GD and to compare it with the Roche TSH Receptor Antibody (TRAb) assay. Design and Methods: Two hundred patients with suspected GD are being enrolled in this single-center multiphase prospective cohort study. Consenting patients undergo biochemical testing including thyroid stimulating hormone (TSH), free T3 (FT3) and T4 (FT4), TRAb and TSI measurements. GD diagnosis was confirmed by endocrinologists that were blinded to TSI results. Results: To date, 85 patients were included in the analysis, of which 66 were diagnosed with GD. For the primary analysis, all patients taking anti-thyroid drugs (ATD) at time of sample collection (n=14) were removed. The respective sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) for TSI was 98, 84, 94 and 94%, which were comparable to those generated by TRAb (98, 95, 95, and 98%). In patients with clinical findings of GD (ie. orbitopathy or goiter, n=33), both the TSI and TRAb assays had identical sensitivity and specificity at 96% and 80% respectively. In patients without orbitopathy or goiter (n=38), the TSI assay had perfect sensitivity and excellent specificity of 100% and 86% respectively (TRAb had 100% sensitivity and specificity). Sensitivity, specificity, NPV, and PPV were slightly lower for both TSI and TRAb in patients treated with ATDs compared to patients without treatment (TSI: 85, 84, 62, 95%; TRAb: 91, 95, 75, 98%). Of ten patients with GD and false negative TSI results, nine were on ATDs. Of this subset, four patients had discordant results between TSI (negative) and TRAb (positive). Notably, one of these patients had normalization of their FT3 and FT4 on the day of sample collection. Discussion and Conclusion: Based on our preliminary results, TSI is an excellent marker for diagnosing GD, particularly in untreated GD patients. The performance of the TSI assay has been comparable to the TRAb assay and correlates well with clinical findings. Discordant false negative results were only seen in patients on ATD. One potential explanation is that the TSI assay is detecting a decrease in stimulating autoantibodies when there is normalization of FT3 and FT4. Importantly, all discordant samples will be tested by a TSI bioassay to confirm diagnosis. Further patient enrollment is occurring, and prognostic assessment of these assays will soon be possible.

Differences in clinical predictors of influenza in adults and children with influenza-like illness

Open Medicine ◽  
2010 ◽  
Vol 5 (1) ◽  
pp. 41-48 ◽  
Author(s):  
Maja Sočan ◽  
Katarina Prosenc ◽  
Mateja Nagode
Keyword(s):  
Clinical Data ◽  
Predictive Value ◽  
Influenza A ◽  
Influenza Infection ◽  
Care Hospital ◽  
Rt Pcr ◽  
Clinical Predictors ◽  
Influenza Like Illness ◽  
Breath Sounds ◽  
Sensitivity Specificity

AbstractInfluenza contributes significantly to morbidity and mortality in the winter season. The aim of the study was to identify clinical signs and symptoms most predictive of influenza infection in children and adults with influenza-like illness. A prospective systematic sampling analysis of clinical data collected through sentinel surveillance system for influenza in 32 primary care centers and one tertiary care hospital in Slovenia during two consecutive influenza seasons (2004/2005 and 2005/2006) was carried out. Children and adults who had influenza-like illness, defined as febrille illness with sudden onset, prostration and weakness, muscle and joint pain and at least (cough, sore throat, coryza) were included and tested for influenza A and B virus, adenovirus, respiratory syncytial virus and enterovirus by RT-PCR. Clinical data were evaluated in statistical models to identify the best predictors for the confirmation of influenza for children (under age of 15) and adults. Of 1,286 patients with influenza-like symptoms in both seasons 211 were confirmed to have influenza A or B alone and compared to 780 influenza-negative patients. A fever over 38°C, chills, headache, malaise and sore eyes revealed a significant association with positive RT-PCR test for influenza virus in children. In adults, only three symptoms were significantly related to PCR-confirmed influenza infection: fever, cough and abnormal breath sounds. The stepwise logistic regression analysis showed that four symptoms predicted influenza in children: fever (38°C or more) (p=0.010), headache (p=0.030), cough (p=0.044) and absence of abnormal breathing sounds (p=0.015) with sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of 5.1%, 98.1%, 57.1% and 80.1%, respectively. For adults, the strongest impact on influenza positivity was found for fever (p=0.008) and cough (p=0.085). The model for adults had less favorable characteristics, with sensitivity, specificity, PPV and NPV of 0%, 100%, 0% and 76.4%, respectively. Differences in clinical predictors of influenza in children compared to adults were found. The model for adults was acceptable but not a good one. The model for children was found to be more reliable than the prediction model for adults.

scholarly journals T2Candida Assay in the Diagnosis of Intraabdominal Candidiasis: A Prospective Multicenter Study

2022 ◽  
Vol 8 (1) ◽  
pp. 86
Author(s):  
Anders Krifors ◽  
Måns Ullberg ◽  
Markus Castegren ◽  
Johan Petersson ◽  
Ernesto Sparrelid ◽  
...  
Keyword(s):  
Predictive Value ◽  
Pathogen Detection ◽  
Necrotizing Pancreatitis ◽  
Gastrointestinal Surgery ◽  
Dual Infection ◽  
Ease Of Use ◽  
Lower Sensitivity ◽  
High Dependency ◽  
Detection Assay ◽  
Sensitivity Specificity

The T2Candida magnetic resonance assay is a direct-from-blood pathogen detection assay that delivers a result within 3–5 h, targeting the most clinically relevant Candida species. Between February 2019 and March 2021, the study included consecutive patients aged >18 years admitted to an intensive care unit or surgical high-dependency unit due to gastrointestinal surgery or necrotizing pancreatitis and from whom diagnostic blood cultures were obtained. Blood samples were tested in parallel with T2Candida and 1,3-β-D-glucan. Of 134 evaluable patients, 13 (10%) were classified as having proven intraabdominal candidiasis (IAC) according to the EORTC/MSG criteria. Two of the thirteen patients (15%) had concurrent candidemia. The sensitivity, specificity, positive predictive value, and negative predictive value, respectively, were 46%, 97%, 61%, and 94% for T2Candida and 85%, 83%, 36%, and 98% for 1,3-β-D-glucan. All positive T2Candida results were consistent with the culture results at the species level, except for one case of dual infection. The performance of T2Candida was comparable with that of 1,3-β-D-glucan for candidemic IAC but had a lower sensitivity for non-candidemic IAC (36% vs. 82%). In conclusion, T2Candida may be a valuable complement to 1,3-β-D-glucan in the clinical management of high-risk surgical patients because of its rapid results and ease of use.

scholarly journals ASSESSMENT OF PERFORMANCE AND IMPLEMENTATION CHARACTERISTICS OF RAPID POINT OF CARE SARS-CoV-2 ANTIGEN TESTING IN KENYA

2021 ◽  
Author(s):  
Jesse Gitaka ◽  
Eva Muthamia ◽  
Samuel Mbugua ◽  
Mary Mungai ◽  
Gama Bandawe ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Test Performance ◽  
Gold Standard ◽  
Point Of Care ◽  
Turnaround Time ◽  
Ease Of Use ◽  
Control Measures ◽  
Antigen Test ◽  
Rt Pcr ◽  
Predictive Values

Abstract Background: The COVID-19 pandemic has resulted in a need for rapid identification of infectious cases. Testing barriers have prohibited adequate screening for SARS COV2, resulting in significant delays in treatment provision and commencement of outbreak control measures. This study aimed to generate evidence on the performance and implementation characteristics of the BD Veritor rapid antigen test as compared to the gold standard test for diagnosis of SARS COV2 in Kenya. Methods: This was a field test performance evaluation in symptomatic and asymptomatic adults undergoing testing for SARS COV2. Recruited participants were classified as SARS-CoV2-positive based on the locally implemented gold standard reverse transcription polymerase chain reaction (RT-PCR) test performed on nasopharyngeal swabs. 272 antigen tests were performed with simultaneous gold standard testing, allowing us to estimate sensitivity, specificity, positive and negative predictive values for the BD Veritor rapid antigen test platform. Implementation characteristics were assessed using the Consolidated Framework for Implementation Research for feasibility, acceptability, turn-around time, and ease-of-use metrics. Results and Discussion: We enrolled 97 PCR negative symptomatic and 128 PCR negative asymptomatic, and 28 PCR positive symptomatic and 19 PCR positive asymptomatic participants. Compared to the gold standard, the sensitivity of the BD Veritor antigen test was 94% (95% confidence interval [CI] 86.6 to 100.0) while the specificity was 98% (95% confidence interval [CI] 96 to 100). The sensitivity of BD Veritor antigen test was higher among symptomatic (100%) compared to asymptomatic (84%) participants, although this difference was not statistically significant. There was also a lack of association between cycle threshold value and sensitivity of BD Veritor test. The BD Veritor test had quick turnaround time and minimal resource requirements, and laboratory personnel conducting testing felt that it was easier to use than the gold standard RT-PCR. Conclusion: The BD Veritor rapid antigen test exhibited excellent sensitivity and specificity when used to detect SARS-CoV-2 infection among both symptomatic and asymptomatic individuals in varied population settings in Kenya. It was feasible to implement and easy to use, with rapid turnaround time.

scholarly journals Potential applications of the rapid COVID-19 antibody test kit screening in comparison to the RT-PCR in patients and personnel at the Department of Obstetrics and Gynecology.

2021 ◽  
Author(s):  
Amarin Narkwichean ◽  
Wittaya Jomoui ◽  
Wipada Laosooksathit ◽  
Tanawin Nopsopon ◽  
Krit Pongpirul
Keyword(s):  
False Positive Rate ◽  
Antibody Test ◽  
Medical Personnel ◽  
Obstetrics And Gynecology ◽  
Rt Pcr ◽  
Risk Area ◽  
Asymptomatic Patients ◽  
Test Kit ◽  
Potential Applications ◽  
Rapid Antibody

Objective To explore potential applications of the rapid antibody test for COVID-19 screening, in comparison to RT-PCR, for emergency obstetric and gynecological procedures, and medical personnel in the Department of Obstetrics and Gynecology. Methods A cross-sectional study was conducted in expected 290 participants: 230 patients and 60 medical staff, during the four-month national COVID-19 outbreak period (Aug-Sep 2020, and Dec 2020-Jan 2021). All participants underwent both rapid antibody tests and RT-PCR (at admission for patients). Results A total of 270 participants completed the study. Fever and URI symptoms were present in 6/210 patients (2.8%) while one patient (0.5%) had a history of traveling to a high-risk area. However, only two (1%) asymptomatic patients had positive IgM results. Concerning the medical personnel, 10% fell into the patient under investigation (PUI) category. 4/60 (6.7%) IgM positive was observed in the staff cohort in which 3/4 came from non-PUI participants. Neither participant had RT-PCR positive demonstrating a 1.9% total false positive rate. Conclusion Rapid point-of-care antibody test can be used to screen either a pregnant coming for delivery, a patient who requires urgent/emergency operative procedures, or medical personnel, at least in the defined lower-prevalence COVID-19 situation.

scholarly journals Assessment of the Rapid Immunochromatographic Test as a Diagnostic Tool for Norovirus Related Diarrhea in Children

2019 ◽  
Vol 55 (1) ◽  
pp. 48
Author(s):  
Reza Gunadi Ranuh ◽  
Alpha Fardah Athiyyah ◽  
Deanty Ayu PA ◽  
Andy Darma ◽  
Dadik Rahardjo ◽  
...  
Keyword(s):  
Developing Countries ◽  
Diagnostic Tool ◽  
Predictive Value ◽  
Gold Standard ◽  
Pediatric Patients ◽  
Immunochromatographic Test ◽  
Rt Pcr ◽  
Gold Standard Method ◽  
Stool Samples ◽  
Sensitivity Specificity

In developing countries, Norovirus is the second-leading cause of acute diarrhea, after rotavirus. The approved gold standard method for diagnosis of norovirus infection is RT-PCR. The rapid immunochromatographic test is a novel and expedient method for diagnosing norovirus that is relatively affordable. However, the use of the rapid immunochromatographic test remains controversial because of its accuracy. This study aimed to explore whether the rapid immunochromatographic test could be used for diagnosing norovirus-related diarrhea in children. Rapid immunochromatographic test (QuickNaviTM-Norovirus2) and RT-PCR on stool samples was used to diagnose norovirus. Stool samples were obtained from pediatric patients aged between 1 and 60 months who had diarrhea and were admitted to the pediatric ward at Dr. Soetomo General Hospital Surabaya, between April 2013 and March 2014. Ninety-four subjects provided stool samples that were tested using QuickNaviTM-Noro2 and RT-PCR. Using the test, 64 samples tested positive for norovirus and 30 tested negatives. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the rapid immunochromatographic test were consecutively 90.3%, 42.9%, 43.8%, 90%, and 58.5%. RT-PCR was used to test all samples to assess the accuracy, which showed that one from 31 samples contained the GI strain (1.1%), while 30 samples (32%) contained the GII strain. This study definitively establishes that the rapid immunochromatography test is not sufficiently accurate for use as a screening or diagnostic tool in norovirus-related diarrhea cases in children.

scholarly journals Coronavirus Disease 2019 (COVID-19) in Italy: Double reading of chest CT examination

2020 ◽  
Author(s):  
Reginelli Alfonso ◽  
Grassi Roberto ◽  
Feragalli Beatrice ◽  
Belfiore Maria Paola ◽  
Montanelli Alessandro ◽  
...  
Keyword(s):  
Predictive Value ◽  
False Negative ◽  
Viral Pneumonia ◽  
Ct Diagnosis ◽  
Rt Pcr ◽  
Ct Examination ◽  
Polymerase Chain ◽  
Sensitivity Specificity ◽  
Age Range ◽  
Pcr Test

Abstract OBJECTIVETo assess the performance of the second reading of chest Compute Tomography (CT) examinations by expert radiologists in patients with discordance between the reverse transcription real-time fluorescence polymerase chain reaction (RT-PCR) test for COVID-19 viral pneumonia and the first CT report.MATERIALS AND METHODS.Three hundred seventy-heigth patients were included in this retrospective study (121 women and 257 men; 71 years of median age - range, 29–93 years) subjected to RT-PCR test for suspicious COVID-19 infection. All patients were subjected to CT examination in order to evaluate the pulmonary disease involvement by COVID-19. CT images were reviewed first by two radiologists who identified COVID-19 typical CT patterns and then reanalyzed by anoter two radiologists using a CT structured report for COVID-19 diagnosis.RESULTS.The median temporal window between RT-PCRs execution and CT scan was 0 days with a range of [-9, 11] days. RT-PCR test was resulted positive in 328/378 (86.8%). Discordance between RT-PCR and CT findings for viral pneumonia was revealed in 60 cases. The second reading changed the CT diagnosis in 16/60 (26.7%) cases contributing to increase the concordance with the RT-PCR. Among these 60 cases, 8 were false negative with positive RT-PCR, and 36 were false positive with negative RT-PCR. Sensitivity, specificity, positive predictive value and negative predictive value of CT were respectively of 97.3%, 53.8%, 89.0%, and 88.4%.CONCLUSION.Double reading of CT could increase the diagnostic confidence of radiological interpretation in COVID-19 patients. Using expert second readers could reduce the rate of discrepant cases between RT-PCR results and CT diagnosis for COVID-19 viral pneumonia.

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