¿Cuál es la precisión diagnóstica de las pruebas covid-19 disponibles?

(What is the diagnostic accuracy of the available covid-19 tests?)


Primeras 5 respuestas:

  1. The accuracy of commercially available tests for COVID-19 in Brazil remains unclear.

  2. The accuracy of clinical diagnosis based on case definitions is unclear but is likely not ideal for diagnosis.

  3. on average 44% to 87% will be falsely identified as not having infection.

  4. a sensitivity of 0.920 will lead to a false negative result in almost one in ten positive patients.

  5. RT-PCR demonstrated 81.4% sensitivity, 100% specificity and 92.3% accuracy.



The accuracy of commercially available tests for COVID-19 in Brazil remains unclear.

... The accuracy of commercially available tests for COVID-19 in Brazil remains unclear. We aimed to perform a meta-analysis to describe the accuracy of available tests to detect COVID-19 in Brazil. We searched at the Brazilian Health Regulatory Agency (ANVISA) online platform to ...

Ref: COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil [Braz J Infect Dis, 2020]


The accuracy of clinical diagnosis based on case definitions is unclear but is likely not ideal for diagnosis.

... studies lack specific details as to how patients were classified as having suspected COVID-19 infection. The accuracy of clinical diagnosis based on case definitions is unclear but is likely not ideal for diagnosis. Additionally, duration of symptoms at the time of clinical diagnosis or rRT-PCR testing was not ...

Ref: The Estimation of Diagnostic Accuracy of Tests for COVID-19: A Scoping Review [J Infect, 2020-08-31]


on average 44% to 87% will be falsely identified as not having infection.

... acute covid-19. For example, of those tested for covid-19 within one week of symptom onset, on average 44% to 87% will be falsely identified as not having infection. And while sensitivity estimates were higher in the third week or later, even at this ...

Ref: Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis [BMJ, 2020-07-01]


a sensitivity of 0.920 will lead to a false negative result in almost one in ten positive patients.

... infection because a positive result does not specify which respiratory viral pathogen is present. However, a sensitivity of 0.920 will lead to a false negative result in almost one in ten positive patients. This is an important consideration for settings with a high prevalence of disease in tested ...

Ref: FebriDx point-of-care test in patients with suspected COVID-19: a pooled diagnostic accuracy study [BMJ, 2020-10-20]


RT-PCR demonstrated 81.4% sensitivity, 100% specificity and 92.3% accuracy.

... with COVID-19 were evaluated; 1045 had tomographic findings while 755 showed positive RT-PCR for COVID-19. RT-PCR demonstrated 81.4% sensitivity, 100% specificity and 92.3% accuracy. Chest CT demonstrated 95.3% sensitivity, 43.8% specificity and 63.3% accuracy. CONCLUSION The high sensitivity and ...

Ref: Reverse-transcriptase polymerase chain reaction versus chest computed tomography for detecting early symptoms of COVID-19. A diagnostic accuracy systematic review and meta-analysis. [Sao Paulo medical journal = Revista paulista de medicina, 2020-08-19]


14 In the US test set, this approach had a reported sensitivity of 66% and a specificity of 83%.

... of smartphone-enabled, self-reported symptom tracker records to predict potential COVID-19 cases using logistic regression models. 14 In the US test set, this approach had a reported sensitivity of 66% and a specificity of 83%. However, the performance of this or other machine learning models in clinical settings has not ...

Ref: Ruling In and Ruling Out COVID-19: Computing SARS-CoV-2 Infection Risk From Symptoms, Imaging and Test Data. [Sao Paulo medical journal = Revista paulista de medicina, 2020-09-22]


Diagnostic performance is presented as positive agreement and negative predictive value with associated 95% CI.

... negative, the paired NP sample was then tested on the m 2000 instrument for concordance. During the study period, results were used to determine patient disease status in standard care. Diagnostic performance is presented as positive agreement and negative predictive value with associated 95% CI. ...

Ref: Diagnostic Performance of a Rapid Point of Care Test for SARS‐CoV‐2 in an Urban ED Setting [Acad Emerg Med, 2020-06-03]


delivers positive results within 5 minutes and negative results in 13 minutes.

... diagnostic kit with EUA approval from the FDA is the ID NOW COVID-19 test which delivers positive results within 5 minutes and negative results in 13 minutes. The platform eliminates thermocycling and performs isothermal nucleic acid amplification technology with a sequence-specific fluorescent ...

Ref: COVID‐19 Clinical Diagnostics and Testing Technology [Pharmacotherapy, 2020-07-08]


The specificity is low.

... offers the great sensitivity for detecting COVID-19, especially in a region with severe epidemic situation. The specificity is low. In the context of emergency disease control, chest CT provides a fast, convenient, and effective ...

Ref: Chest CT for detecting COVID-19: a systematic review and meta-analysis of diagnostic accuracy [Eur Radiol, 2020-05-15]


the accuracy of commercially available tests for COVID-19 in Brazil remains unclear.

... unmitigated strategy. 4 Though massive testing is a cornerstone to reduce the burden of COVID-19, the accuracy of commercially available tests for COVID-19 in Brazil remains unclear. The aim of this study was to perform a meta-analysis to describe the accuracy of ...

Ref: COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil [The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases, 2020-04-18]


The sensitivity of these tests varied considerably, but specificity was high.

... rapid tests that are available for the detection of respiratory viruses in patients with RTIs. The sensitivity of these tests varied considerably, but specificity was high. With the result of the rapid test it is thus possible to rule in a ...

Ref: Rapid Tests for Influenza, Respiratory Syncytial Virus, and Other Respiratory Viruses: A Systematic Review and Meta-analysis [Clin Infect Dis, 2017-09-15]


OSs obtained from 2 of the 75 participants in the first study yielded positive results for SARS-CoV-2 nucleic acid.

... the McNemar"s test was used for difference analysis and the kappa statistic for consistency analysis. OSs obtained from 2 of the 75 participants in the first study yielded positive results for SARS-CoV-2 nucleic acid. Both were male and aged >60 y. Subsequent chemiluminescence enzyme immunoassays indicated that they were ...

Ref: Oropharyngeal Secretion as Alternative for SARS-CoV-2 Detection [J Dent Res, 2020]


Prior studies found a high sensitivity (97%) and low to moderate specificity (25-56%),

... Prior studies found a high sensitivity (97%) and low to moderate specificity (25-56%), however they did not define the criteria used to classify chest CT findings as positive in that study (11, 18) . On the other hand, Bai et al. demonstrated that ...

Ref: Chest CT accuracy in the diagnosis of SARS-CoV-2 infection: initial experience in a cancer center [Radiol Bras, 2020]


diagnostic accuracy of individual signs and symptoms is low, especially sensitivity.

... tests, only for individual signs and symptoms. The results are summarised in Table 2 Overall, diagnostic accuracy of individual signs and symptoms is low, especially sensitivity. In addition, results were highly variable across studies, making it di icult to draw firm ...

Ref: Signs and symptoms to determine if a patient presenting in primary care or hospital outpatient settings has COVID‐19 disease [Cochrane Database Syst Rev, 2020-07-07]


Though molecular diagnostic tests are the gold standard for COVID-19, serological testing is emerging as a potential surveillance tool,

... caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been spreading throughout the world. Though molecular diagnostic tests are the gold standard for COVID-19, serological testing is emerging as a potential surveillance tool, in addition to its complementary role in COVID-19 diagnostics. Indubitably quantitative serological testing provides greater ...

Ref: Diagnostic accuracy of an automated chemiluminescent immunoassay for anti-SARS-CoV-2 IgM and IgG antibodies: an Italian experience [J. med. virol, 2020]


the accuracy of commercially available tests for COVID-19 remain unclear.

... are a cornerstone of strategies aimed to reduce the social and economic burden of COVID-19, the accuracy of commercially available tests for COVID-19 remain unclear. Currently nucleic acid amplification tests (NAATs), such as real-time reversetranscription polymerase chain reaction (real-time RT-PCR) ...

Ref: Diagnostic Characteristics of Serological-Based COVID-19 Testing: A Systematic Review and Meta-Analysis [Clinics (Sao Paulo), 2020-08-06]


Random-effects models yielded a summary sensitivity of 82% for IgM, and 85% for IgG and total antibodies.

... We reviewed the diagnostic accuracy of SARS-CoV-2 serological tests. Random-effects models yielded a summary sensitivity of 82% for IgM, and 85% for IgG and total antibodies. For specificity, the pooled estimate were 98% for IgM and 99% for IgG and total antibodies. In populations with ≤ 5% ...

Ref: Meta-analysis of diagnostic performance of serological tests for SARS-CoV-2 antibodies up to 25 April 2020 and public health implications [Euro Surveill, 2020-06-11]


The overall testing sensitivity was 88.66% and specificity was 90.63%.

... can detect SARS-CoV-2 IgM and IgG antibodies in the blood of patients at different stages of infection. The overall testing sensitivity was 88.66% and specificity was 90.63%. However, there is limited clinical information on the SARS-CoV-2 antibody test (colloidal gold). ...

Ref: Clinical application of combined detection of SARS-CoV-2-specific antibody and nucleic acid [World J Clin Cases, 2020-10-06]


the diagnosis is difficult due to its 153 non-featured clinical manifestations and symptoms.

... The pandemic of COVID-19 is a public health concern; however, the diagnosis is difficult due to its 153 non-featured clinical manifestations and symptoms. Rapid, reliable, and easy-to-implement diagnostics 154 that can be applied to SARS-CoV-2 are an urgent requirement. Herein, we show that ...

Ref: Accuracy of a nucleocapsid protein antigen rapid test in the diagnosis of SARS-CoV-2 infection [Clin Microbiol Infect, 2020-10-05]


Nucleic acid amplification technology for molecular diagnostics remains the gold standard for virus detection.

... severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) testing as well as address their advantages and limitations. Nucleic acid amplification technology for molecular diagnostics remains the gold standard for virus detection. We highlight alternative molecular detection techniques used for developing novel COVID-19 diagnostics on the horizon. ...

Ref: COVID-19 Clinical Diagnostics and Testing Technology [Pharmacotherapy, 2020]


With a sensitivity of 90.2% and specificity of 88.2%,

... with suspected COVID-19 presenting to the ED were assessed by chest CT and nasopharyngeal swabs. With a sensitivity of 90.2% and specificity of 88.2%, the chest CT performed relatively well as a diagnostic modality compared with the first RT-PCR ...

Ref: Chest CT for triage during COVID-19 on the emergency department: myth or truth? [Emerg Radiol, 2020-07-20]


The overall accuracy rate reached 97.3%.

... determined to be 97.5% by testing against 69 samples from hospitalized and/or recovered COVID-19 patients. The overall accuracy rate reached 97.3%. Most importantly, in one case study, the ELISA test kit was able to identify an ...

Ref: Serological diagnostic kit of SARS-CoV-2 antibodies using CHO-expressed full-length SARS-CoV-2 S1 proteins [Emerg Radiol, 2020-03-27]


The duo SARS-CoV-2 assay performed equally, or better, in terms of sensitivity, specificity, linearity and signal intensity.

... test; the resulting duo SARS-CoV-2 RT-qPCR assay was compared to the two parental monoplex tests. The duo SARS-CoV-2 assay performed equally, or better, in terms of sensitivity, specificity, linearity and signal intensity. We demonstrated that combining two single systems into a dual-target assay (with or without an ...

Ref: Development and Evaluation of a duo SARS-CoV-2 RT-qPCR Assay Combining Two Assays Approved by the World Health Organization Targeting the Envelope and the RNA-Dependant RNA Polymerase (RdRp) Coding Regions [Viruses, 2020]


A model using all 5 diagnostic symptoms had the highest accuracy with a predictive ability of 82% in discriminating between COVID-19 results.

... of breath and sore throat were associated with a negative test result (p < 0.05). A model using all 5 diagnostic symptoms had the highest accuracy with a predictive ability of 82% in discriminating between COVID-19 results. To maximize sensitivity and maintain fair diagnostic accuracy, a combination of 2 symptoms, change in ...

Ref: Smell and taste symptom-based predictive model for COVID-19 diagnosis [Int Forum Allergy Rhinol, 2020]


Our results show that it could achieve an accuracy of 97.4% on an independent test set.

... COVID-19 TestNorm was developed and evaluated using 568 test names collected from 8 healthcare systems. Our results show that it could achieve an accuracy of 97.4% on an independent test set. COVID-19 TestNorm is available as an open-source package for developers and as an online Web ...

Ref: COVID-19 TestNorm: A tool to normalize COVID-19 testing names to LOINC codes [J Am Med Inform Assoc, 2020]


The false positive rate for the Panbio TM COVID-19 IgG/IgM Rapid Test Device is 0.6% (1/164).

... likely due to crossreactivity between the sample and the components of the Panbio TM assay. The false positive rate for the Panbio TM COVID-19 IgG/IgM Rapid Test Device is 0.6% (1/164). A limitation of the present study was that only serum and plasma samples were tested, ...

Ref: A Comparative Evaluation between the Abbott Panbio(TM) COVID-19 IgG/IgM Rapid Test Device and Abbott Architect(TM) SARS CoV-2 IgG Assay [J Clin Virol, 2020-09-16]


Diagnostic accuracy was determined by analyzing receiver operating characteristic (ROC) curve, calculating the area under the ROC curve (AUC) and the cutoff value.

... Patients were classified into two groups according to RT-PCR COVID-19: positive (COVID-19) or negative (NON-COVID-19). Diagnostic accuracy was determined by analyzing receiver operating characteristic (ROC) curve, calculating the area under the ROC curve (AUC) and the cutoff value. In order to reduce the number of false positives, the cutoff value with a specificity ...

Ref: Evaluation of Routine Blood Tests for Diagnosis of Suspected Coronavirus Disease 2019 [Clinical laboratory, 2020]


Despite its high sensitivity in diagnosing COVID-19, chest CT had low specificity (25%),

Despite its high sensitivity in diagnosing COVID-19, chest CT had low specificity (25%), as shown in a report of 1014 patients with COVID-19 [2] .

Ref: Chest CT in patients with a moderate or high pretest probability of COVID-19 and negative swab [Radiol Med, 2020-08-29]


Accurate testing allows identification of people who might need treatment,

... whether they currently have COVID‐19 or have had it previously Why are accurate tests important? Accurate testing allows identification of people who might need treatment, or who need to isolate themselves to prevent the spread of infection Failure to detect ...

Ref: cord_uid sa375nzp Antibody tests for identification of current a... sa375nzp Antibody tests for identification of current a... sa375nzp Antibody tests for identification of current a... Name: title, dtype: object [Radiol Med, cord_uid sa375nzp 2020 sa375nzp 2020 sa375nzp 2020 Name: publish_time, dtype: object]


radiologists' sensitivity for diagnosing COVID-19 by CT findings ranges from 72% to 94% with specificity from 24% to 100%.

... as reduced mortality or faster resolution of COVID-19 symptoms has been described. 93 In addition, radiologists" sensitivity for diagnosing COVID-19 by CT findings ranges from 72% to 94% with specificity from 24% to 100%. 94 Preliminary artificial intelligence studies report radiologists" sensitivity improves from 79% to 88% and specificity ...

Ref: Diagnosing COVID‐19 in the Emergency Department: A Scoping Review of Clinical Exam, Labs, Imaging Accuracy and Biases [Acad Emerg Med, 2020-06-16]


The Augurix IgG-RDT done in whole blood displays a high diagnostic accuracy for SARS-CoV-2 IgG

... >14 days after RT-PCR diagnosis, NPV was 100% (95%CI:90-100), and PPV was 100% (95%CI:72-100). CONCLUSIONS: The Augurix IgG-RDT done in whole blood displays a high diagnostic accuracy for SARS-CoV-2 IgG in high COVID-19 prevalence settings, where its use could be considered in the absence of ...

Ref: Diagnostic accuracy of Augurix COVID-19 IgG serology rapid test [Eur J Clin Invest, 2020]


Confirmed COVID-19 case counts underestimate infections.

... Confirmed COVID-19 case counts underestimate infections. When correcting for incomplete testing and imperfect test accuracy, we estimated that the total number of SARS-CoV-2 infections in the U.S. by April 18, 2020 was 6,454,951 (19 per 1000)an ...

Ref: Substantial underestimation of SARS-CoV-2 infection in the United States [Nat Commun, 2020-09-09]


Any deviation of the diagnostic sensitivity and specificity will reduce the predictive values of the test.

... To combat the COVID‐19 pandemic, millions of PCR tests are performed worldwide. Any deviation of the diagnostic sensitivity and specificity will reduce the predictive values of the test. Here, we report the occurrence of contaminations of commercial primers/probe sets with the SARS‐CoV‐2 target sequence of the ...

Ref: Pitfalls in SARS‐CoV‐2 PCR diagnostics [Transbound Emerg Dis, 2020-06-14]


the specificity was above 94% for all tests.

... ELISAs showed sensitivities of 88.4% for RBD, 89.3% for S1, and 72.9% for N protein, the specificity was above 94% for all tests. Out of 54 SARS-CoV-2 positive individuals, 96.3% showed full neutralization of live SARS-CoV-2 at serum ...

Ref: Accuracy of serological testing for SARS-CoV-2 antibodies: first results of a large mixed-method evaluation study [Allergy, 2020]


Many SARS-Cov-2 diagnostic tests allow for patients to self-collect a specimen.

... Guidance for collecting specimens is available from multiple sources. 27, [39] [40] Many SARS-Cov-2 diagnostic tests allow for patients to self-collect a specimen. Pharmacists should be able to provide proper instruction for patients to self-collect a specimen. Pharmacists will need to ...

Ref: The Pharmacist’s Role in SARS-CoV-2 Diagnostic Testing [J Am Pharm Assoc (2003), 2020-08-11]


Their overall diagnostic accuracy was adequate with a high specificity but limited sensitivity.

... a weaker reactivity against N protein became apparent. The time to seroconversion varied substantially between COVID-19 patients but the IgG response was robust and stable in all three ELISA setups. Their overall diagnostic accuracy was adequate with a high specificity but limited sensitivity. ...

Ref: Accuracy of serological testing for SARS‐CoV‐2 antibodies: first results of a large mixed‐method evaluation study [Allergy, 2020-09-30]


Proposed models can predict COVID-19 qRT-PCR results in symptomatic individuals with high accuracy, sensitivity and specificity.

... Adjusts in assumed prior probabilities allow fine-tuning of the model, according to actual prediction context. Proposed models can predict COVID-19 qRT-PCR results in symptomatic individuals with high accuracy, sensitivity and specificity. Data assessment can be performed in an individual or simultaneous basis, according to desired outcome. ...

Ref: Hemogram Data as a Tool for Decision-making in COVID-19 Management: Applications to Resource Scarcity Scenarios [Allergy, 2020-05-10]


These tests are largely based on four different techniques, as shown in Table 1 .

... diagnostic tests for COVID-19 are available so far, with more gaining emergency approval every day. These tests are largely based on four different techniques, as shown in Table 1 . The current diagnosis of COVID-19 infection relies mainly on the centralized laboratory-based rRT-PCR. Although rRT-PCR ...

Ref: Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2 [Viruses, 2020-05-26]


We showed a high sensitivity for COVID-19 diagnosis when compared to SARS-CoV-2 RT PCR testing as the gold standard.

... of these biomarkers as a proxy for testing in locations where COVID-19 testing is scarce. We showed a high sensitivity for COVID-19 diagnosis when compared to SARS-CoV-2 RT PCR testing as the gold standard. The blood biomarkers included in the model can be obtained with a single blood draw ...

Ref: A machine learning algorithm to increase COVID-19 inpatient diagnostic capacity [PLoS One, 2020-09-22]


the diagnostic accuracy of this technique shall be considered a foremost prerequisite.

... SARS-CoV-2 infection is (real time) reverse transcription polymerase chain reaction (rRT-PCR) on respiratory tract specimens, the diagnostic accuracy of this technique shall be considered a foremost prerequisite. Overall, potential RT-PCR vulnerabilities include general preanalytical issues such as identification problems, inadequate procedures for ...

Ref: Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19). [Clinical chemistry and laboratory medicine, 2020-03-16]


Measures of accuracy were estimated to assess sensitivity in 176 hospitalized Covid-19 clinical subjects at least 14 days after a diagnostic PCR-positive assay result.

... Setting: 6 major health facilities in Tuscany, Italy. Participants: 17,098 HCW of the Tuscany Region. Measures of accuracy were estimated to assess sensitivity in 176 hospitalized Covid-19 clinical subjects at least 14 days after a diagnostic PCR-positive assay result. Specificity was assessed in 295 sera biobanked in the pre-Covid-19 era in winter or summer ...

Ref: Detection of asymptomatic SARS-CoV-2 infections among healthcare workers: results from a large-scale screening program based on rapid serological testing. [Clinical chemistry and laboratory medicine, 2020-08-04]


The overall accuracy of these tests, however, has not been well-defined.

... of immunoglobulin or immunoglobulin combinations and detect antibodies directed against different portions of the virus. The overall accuracy of these tests, however, has not been well-defined. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic ...

Ref: Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19:Serologic Testing [Clinical chemistry and laboratory medicine, 2020]


COVID‐19‐positive cases who are RT‐PCR‐negative should be included as well as those confirmed RT‐PCR,

... considerable improvement Studies must report data on sensitivity disaggregated by time since onset of symptoms COVID‐19‐positive cases who are RT‐PCR‐negative should be included as well as those confirmed RT‐PCR, in accordance with the World Health Organization (WHO) and China National Health Commission of the ...

Ref: cord_uid sa375nzp Antibody tests for identification of current a... sa375nzp Antibody tests for identification of current a... sa375nzp Antibody tests for identification of current a... Name: title, dtype: object [Clinical chemistry and laboratory medicine, cord_uid sa375nzp 2020 sa375nzp 2020 sa375nzp 2020 Name: publish_time, dtype: object]


assess the diagnostic accuracy of routine laboratory testing

... emergency department has SARS-CoV-2 infection, COVID-19 pneumonia, or severe COVID-19 pneumonia/ARDS requiring hospital admission To assess the diagnostic accuracy of routine laboratory testing to determine if a person has COVID-19 pneumonia or SARS-CoV-2 infection Secondary objectives Where data ...

Ref: Diagnosis of SARS-CoV-2 infection and COVID-19: accuracy of signs and symptoms;molecular, antigen, and antibody tests;and routine laboratory markers [Cochrane Database of Systematic Reviews, 2020]


Diagnostic performance was assessed with the area under the receiver operating characteristic curve, sensitivity, and specificity.

... the model. The datasets were collected from six hospitals between August 2016 and February 2020. Diagnostic performance was assessed with the area under the receiver operating characteristic curve, sensitivity, and specificity. Results The collected dataset consisted of 4352 chest CT scans from 3322 patients. The average ...

Ref: Using Artificial Intelligence to Detect COVID-19 and Community-acquired Pneumonia Based on Pulmonary CT: Evaluation of the Diagnostic Accuracy [Radiology, 2020]


They enable a rapid and detailed assessment of tissue and organ involvement in disease processes that are relevant to diagnosis and management,

... BACKGROUND: CT scans are increasingly available in clinical care globally. They enable a rapid and detailed assessment of tissue and organ involvement in disease processes that are relevant to diagnosis and management, particularly since the coronavirus outbreak in the world. OBJECTIVE: We wanted to compare CT scan findings of patients that were ...

Ref: Diagnostic Accuracy of Chest CT Scans for Suspected Patients with COVID-19 in a Retrospective Cohort Study [Radiology, 2020]


The RT-PCR test is then carried out and the test result decides the posterior probability.

... may suspect that a patient has COVID-19, which could be quantified into the prior probability. The RT-PCR test is then carried out and the test result decides the posterior probability. Statistical analysis was done using the R programming language (18) in the RStudio software environment ...

Ref: Reconstructed diagnostic sensitivity and specificity of the RT-PCR test for COVID-19 [Radiology, 2020-04-29]


This was a critical first step that allowed for the development of molecular diagnostic tests to identify the presence of virus.

... of the SARS-CoV2 virus, the cause of COVID-19, was first identified on January 12, 2020. This was a critical first step that allowed for the development of molecular diagnostic tests to identify the presence of virus. 1-3 At the individual patient level, testing for SARS-CoV-2 infection in symptomatic patients helps to ...

Ref: AGA Institute Rapid Review and Recommendations on the Role of Pre-Procedure SARS-CoV2 Testing and Endoscopy [Gastroenterology, 2020-07-28]


We first assessed the test's reproducibility by administering it twice on the same day on 104 subjects obtaining and overall score of 93 percent.

... of the available serological tests, the Prima Lab Covid-19 IgG/IgM Rapid Tests, on 739 volunteers. We first assessed the test"s reproducibility by administering it twice on the same day on 104 subjects obtaining and overall score of 93 percent. Since the intensity of the color in the test line regions varies depending on the ...

Ref: Evaluating the adequacy of Prima Covid-19 IgG/IgM Rapid Test for the assessment of exposure to SARS-CoV-2 virus [Gastroenterology, 2020-06-03]


The diagnosis of COVID-19 relies on the following criteria: clinical symptoms, epidemiological history and positive CT images as well as positive pathogenic testing.

... is crucial to identify infected individuals as early as possible for quarantine and treatment procedures. The diagnosis of COVID-19 relies on the following criteria: clinical symptoms, epidemiological history and positive CT images as well as positive pathogenic testing. The clinical characteristics of COVID-19 include respiratory symptoms, fever, cough, dyspna, and viral pneumonia [2] ...

Ref: A deep learning algorithm using CT images to screen for Corona Virus Disease (COVID-19) [Gastroenterology, 2020-02-17]


However, its diagnostic efficacy remains unclear.

... of anti‐SARS‐CoV‐2 immunoglobulin G (IgG) and/or IgM is widely used in the diagnosis of COVID‐19. However, its diagnostic efficacy remains unclear. In this study, we searched for diagnostic studies from the Web of Science, PubMed, Embase, ...

Ref: Diagnostic efficacy of anti‐SARS‐CoV‐2 IgG/IgM test for COVID‐19: A meta‐analysis [J Med Virol, 2020-07-11]


The detection of viral RNA allows the identification of infected persons, whereas the detection of antibodies may reveal a response to a previous infection.

... In battling the COVID-19 pandemic, testing is essential. The detection of viral RNA allows the identification of infected persons, whereas the detection of antibodies may reveal a response to a previous infection. Tests for coronavirus should be rigorously evaluated in terms of their analytical and clinical performance. This poses not only logistic challenges, but ...

Ref: Testing COVID-19 tests faces methodological challenges [J Clin Epidemiol, 2020]


Test results of a complete viral pathogen panel and COVID-19 testing were abstracted.

... chart review of all patients who received viral testing between March 1, 2020-April 28, 2020. Test results of a complete viral pathogen panel and COVID-19 testing were abstracted. We compared patients with more than one COVID-19 test for diagnostic accuracy against the gold ...

Ref: Practical Diagnostic Accuracy of Nasopharyngeal Swab Testing for Novel Coronavirus Disease 2019 (COVID-19) [J Clin Epidemiol, 2020]


Conclusions Deep learning (DL) with DenseNet can accurately classify COVID-19 on HRCT with an AUC of 0.98,

... respectively. The sensitivity of radiologist was 94%, the specificity was 96%, while the accuracy was 95%. Conclusions Deep learning (DL) with DenseNet can accurately classify COVID-19 on HRCT with an AUC of 0.98, which can reduce the miss diagnosis rate (combined with radiologists" evaluation) and radiologists" workload. ...

Ref: Deep learning for detecting corona virus disease 2019 (COVID-19) on high-resolution computed tomography: a pilot study. [Annals of translational medicine, 2020-04-01]


The diagnostic accuracy was determined in comparison to SARS-CoV-2 RT-PCR.

... and Bioeasy were evaluated using universal transport medium containing naso-oropharyngeal swabs from suspected Covid-19 cases. The diagnostic accuracy was determined in comparison to SARS-CoV-2 RT-PCR. A total of 111 samples were included; 80 were RT-PCR positive. Median patients’ age was ...

Ref: Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of SARS-CoV-2 in respiratory samples [bioRxiv, 2020-05-27]


The reported values of CT sensitivity and specificity calculated using RT-PCR as a reference standard vary widely.

... in COVID-19 screening is associated with ambiguous characteristics of chest CT as a diagnostic test. The reported values of CT sensitivity and specificity calculated using RT-PCR as a reference standard vary widely. The objective of this study was to reevaluate the diagnostic and prognostic value of CT ...

Ref: Diagnostic Accuracy of Computed Tomography for Identifying Hospitalization in Patients with Suspected COVID-19 [bioRxiv, 2020-07-29]


Of over 1,000 unique patient samples tested, 44.1% were positive for SARS-CoV-2 infection.

... studies and reduced institutional sample turnaround time from 5-7 days to less than 24 h. Of over 1,000 unique patient samples tested, 44.1% were positive for SARS-CoV-2 infection. Conclusions: This work provides a blueprint for academic centers and community hospitals lacking automated laboratory ...

Ref: cord_uid o7wu8lbb Rapid Implementation of a SARS-CoV-2 Diagnosti... o7wu8lbb Rapid Implementation of a SARS-CoV-2 Diagnosti... Name: title, dtype: object [bioRxiv, cord_uid o7wu8lbb 2020 o7wu8lbb 2020 Name: publish_time, dtype: object]


Those who test positive, whether symptomatic or not, are presumed to be contagious and risk transmitting the virus;

... currently infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19. Those who test positive, whether symptomatic or not, are presumed to be contagious and risk transmitting the virus; however, some patients who test positive later in the course of infection may have noninfectious ...

Ref: Linking Statistics With Testing Policy to Manage COVID-19 in the Community [Am J Clin Pathol, 2020-06-10]


CT images were analyzed by 2 radiologists blinded to RT-PCR results.

... infection, for which consequent COVID-19 testing was achieved using POCUS lung, chest CT, and RT-PCR. CT images were analyzed by 2 radiologists blinded to RT-PCR results. POCUS lung was performed by three emergency medical doctors, and reports were analyzed by the ...

Ref: Feasibility of using point-of-care lung ultrasound for early triage of COVID-19 patients in the emergency room [Emerg. radiol, 2020]


There is no reference diagnostic test for COVID-19.

... perspectives on COVID-19, to compare with hospitalized patients generally representing more severe cases [19] . There is no reference diagnostic test for COVID-19. Currently available tools are symptom reports and a reverse transcriptase polymerase chain reaction (RT-PCR) assay ...

Ref: COVID-19 symptoms predictive of healthcare workers’ SARS-CoV-2 PCR results [PLoS One, 2020-06-26]


For diagnostic testing, false-negative results could create a false sense of security and contribute to further spread of the virus,

... that have met relevant quality standards. Moreover, such concerns are particularly salient for COVID-19 testing. For diagnostic testing, false-negative results could create a false sense of security and contribute to further spread of the virus, while false-positive test results could keep people out of work, school, or childcare, exacerbating economic ...

Ref: The promise of direct-to-consumer COVID-19 testing: ethical and regulatory issues [J Law Biosci, 2020-09-23]


Suspected COVID-19 patients met the following criteria: Clear history of epidemiological contact, typical clinical symptoms and pulmonary imaging features.

... records in our hospital information system. The patients were clinically diagnosed with COVID-19 according October to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7) [13] . Suspected COVID-19 patients met the following criteria: Clear history of epidemiological contact, typical clinical symptoms and pulmonary imaging features. ...

Ref: Clinical application of combined detection of SARS-CoV-2-specific antibody and nucleic acid [World J Clin Cases, 2020-10-06]


Due to its high specificity and sensitivity, 411 this kit could sensitively and quantitatively measure levels of IgA in blood and other tissues.

... In summary, this study reports a novel sensitive and quantitative serological testing kit of detecting 410 IgA as well as IgM and IgG, for the diagnostics of COVID-19. Due to its high specificity and sensitivity, 411 this kit could sensitively and quantitatively measure levels of IgA in blood and other tissues. The ...

Ref: COVID-19 diagnosis and study of serum SARS-CoV-2 specific IgA, IgM and IgG by a quantitative and sensitive immunoassay [World J Clin Cases, 2020-04-22]


Serology detection is recognized for its sensitivity in convalescent patients with COVID-19,

... Serology detection is recognized for its sensitivity in convalescent patients with COVID-19, in comparison with nucleic acid amplification tests (NAATs). This article aimed to evaluate the diagnostic accuracy of serologic methods for COVID-19 based on assay design and post-symptom-onset intervals. Two authors ...

Ref: Meta-analysis of diagnostic performance of serology tests for COVID-19: impact of assay design and post-symptom-onset intervals [Emerg Microbes Infect, 2020]


The diagnostic accuracy of NP antigen testing was calculated by taking NA testing of RT-PCR as reference standard,

... by RT-PCR were performed simultaneously in a blind manner with the same nasopharyngeal swab sample. The diagnostic accuracy of NP antigen testing was calculated by taking NA testing of RT-PCR as reference standard, in which samples with cycle threshold (Ct) value ≤ 40 were interpreted as SARS-CoV-2 positives. ...

Ref: Accuracy of a nucleocapsid protein antigen rapid test in the diagnosis of SARS-CoV-2 infection [Clin. microbiol. infect, 2020]


COVID-19 swabs had a sensitivity of 84.6%

... for COVID-19. There were 221 repeat tests for COVID-19. Among patients with a repeat test, COVID-19 swabs had a sensitivity of 84.6% (95% confidence interval (CI), 69.5-94.4%) and a specificity of 99.5% (95%CI, 97-100%) compared to a ...

Ref: Practical Diagnostic Accuracy of Nasopharyngeal Swab Testing for Novel Coronavirus Disease 2019 (COVID-19). [The western journal of emergency medicine, 2020-09-28]


The numbers of available SARS-CoV-2 nucleic acid detection tests are rapidly increasing, as is the COVID-19 diagnostic literature.

... nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. The numbers of available SARS-CoV-2 nucleic acid detection tests are rapidly increasing, as is the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) recognized a significant need for frequently updated ...

Ref: cord_uid gp4i8xhv Infectious Diseases Society of America Guideli... gp4i8xhv Infectious Diseases Society of America Guideli... gp4i8xhv Infectious Diseases Society of America Guideli... Name: title, dtype: object [The western journal of emergency medicine, cord_uid gp4i8xhv 2020 gp4i8xhv 2020 gp4i8xhv 2020 Name: publish_time, dtype: object]


We assessed diagnostic accuracy of these characteristics for COVID-19 by calculating positive and negative likelihood ratios.

... of COVID-19 (low, moderate, and high) rated by emergency physicians, depending on their clinical judgment. We assessed diagnostic accuracy of these characteristics for COVID-19 by calculating positive and negative likelihood ratios. RESULTS: We included 391 patients, of whom 225 had positive test results for severe acute ...

Ref: Accuracy of Emergency Department Clinical Findings for Diagnosis of Coronavirus Disease 2019 [Ann Emerg Med, 2020]


Minimum clinical sensitivity for all of the specified intended uses ranged from 85 to 98%, with a median of 95%.

... of COVID-19, determination of exposure to SARS-CoV-2 and determination of the immune status against SARS-CoV-2. Minimum clinical sensitivity for all of the specified intended uses ranged from 85 to 98%, with a median of 95%. These thresholds applied to samples collected at least >14 days post onset of symptoms (dpo), ...

Ref: Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid, antigen and antibody tests up to 22 August 2020 [Ann Emerg Med, 2020-09-18]


With first RT-PCR as reference standard, the diagnostic performance of chest CT using the CO-RADS score was assessed.

... Patient characteristics, demographics, symptoms, vital signs, laboratory tests, and chest CT results (CO-RADS) were collected. With first RT-PCR as reference standard, the diagnostic performance of chest CT using the CO-RADS score was assessed. Additionally, a predictive machine learning model was constructed using logistic regression. RESULTS: Chest CT, with ...

Ref: Chest CT for triage during COVID-19 on the emergency department: myth or truth? [Emerg. radiol, 2020]


Studies of any design that performed tests on ≥10 patients and reported or inferred correlative statistics were included.

... METHODS: We conducted a systematic search of English-language articles published December 31, 2019-June 19, 2020. Studies of any design that performed tests on ≥10 patients and reported or inferred correlative statistics were included. Studies were evaluated using elements of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) guidelines. ...

Ref: The estimation of diagnostic accuracy of tests for COVID-19: A scoping review [J. infect, 2020]


Thirty contrived positive and 30 negative specimens tested, with 95% sensitivity and 100% specificity required for EUA.

... into the desired matrix, rather than using real clinical specimens collected from patients with COVID-19. Thirty contrived positive and 30 negative specimens tested, with 95% sensitivity and 100% specificity required for EUA. Therefore, while we have information regarding the limit of detection of the test and evidence ...

Ref: Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19 [Clin Infect Dis, 2020-06-16]


The specificity, sensitivity, PPV and NPV of the SARS-CoV-2 Antibody Test Kit were calculated.

... pulmonary imaging features were extracted from patients" electronic medical records in our hospital information system. The specificity, sensitivity, PPV and NPV of the SARS-CoV-2 Antibody Test Kit were calculated. A 95% confidence interval (CI) was provided by the Wilson score method. All analyses were ...

Ref: Clinical application of combined detection of SARS-CoV-2-specific antibody and nucleic acid [World J Clin Cases, 2020-10-06]


We found no false positives in patients whose sera were non-neutralising.

... of COVID-19 in order to further evaluate specificity of both tests in routine clinical practice. We found no false positives in patients whose sera were non-neutralising. This is consistent with an estimated specificity of above 99% with the SureScreen assay observed ...

Ref: Combined point of care nucleic acid and antibody testing for SARS-CoV-2 following emergence of D614G Spike Variant [Cell Rep Med, 2020-09-01]


The pace of development has, however, exceeded that of rigorous evaluation, and important uncertainty about test accuracy remains.

... even if they never underwent testing while acutely ill. Many serological tests for covid-19 have become available in a short period, including some marketed for use as rapid, point-of-care tests. The pace of development has, however, exceeded that of rigorous evaluation, and important uncertainty about test accuracy remains. ...

Ref: Benefits and limitations of Serological Assays in COVID-19 Infection [Indian J Tuberc, 2020-08-06]


showing high diagnostic accuracy across readers with different levels of expertise.

... considered a valid tool for the identification of lung involvement in patients with suspected COVID-19, showing high diagnostic accuracy across readers with different levels of expertise. Specificity, in particular, is higher than previously thought and that could lead to reconsider the ...

Ref: Diagnostic accuracy and interobserver variability of CO-RADS in patients with suspected coronavirus disease-2019: a multireader validation study [Eur Radiol, 2020-09-23]


The diagnosis of COVID-19 was made through suggestive symptoms, positive swabs, and consistent imaging in chest radiography and/or Computed Tomography.

The diagnosis of COVID-19 was made through suggestive symptoms, positive swabs, and consistent imaging in chest radiography and/or Computed Tomography.

Ref: The Model for Early COvid-19 Recognition (MECOR) Score: A Proof-of-Concept for a Simple and Low-Cost Tool to Recognize a Possible Viral Etiology in Community-Acquired Pneumonia Patients during COVID-19 Outbreak [Diagnostics (Basel), 2020-08-21]


We selected operational ROC point at a sensitivity of 81.9% and specificity of 97.9%.

... blood tests of 5,333 patients with various bacterial and viral infections, and 160 COVID-19-positive patients. We selected operational ROC point at a sensitivity of 81.9% and specificity of 97.9%. The cross-validated area under the curve (AUC) was 0.97. The five most useful routine blood ...

Ref: COVID-19 diagnosis by routine blood tests using machine learning [Diagnostics (Basel), 2020-06-04]


Our study reports a sensitivity of 52% for CXR, which is lower than the reported 69% for portable CXR.

... Our study reports a sensitivity of 52% for CXR, which is lower than the reported 69% for portable CXR. It is unknown whether the radiologists in that previous study were blinded, and it is also unclear how body mass index or other variables may have resulted in our reported ...

Ref: Point-of-care Lung Ultrasound Is More Sensitive than Chest Radiograph for Evaluation of COVID-19 [West J Emerg Med, 2020-06-19]


its ability to correctly classify those with and without the target condition,

... diagnostic tests. Here clinical performance is typically expressed as the diagnostic accuracy of the test: its ability to correctly classify those with and without the target condition, based on comparisons between the index test result and the outcome of the clinical reference ...

Ref: Testing COVID-19 tests faces methodological challenges [J Clin Epidemiol, 2020-07-03]


we found an overall sensitivity and specificity of 57.6 and 99.5%, respectively with an accuracy of 82.6%.

... study performed in three different clinical laboratories during the ascendant phase of the epidemiological curve, we found an overall sensitivity and specificity of 57.6 and 99.5%, respectively with an accuracy of 82.6%. The cut-off of the ICT was found at CT <22. User-friendliness analysis and risk management ...

Ref: Development and Potential Usefulness of the COVID-19 Ag Respi-Strip Diagnostic Assay in a Pandemic Context [Front. Med., 2020]


the Accula SARS-CoV-2 test has a lower 135 sensitivity for diagnosis of COVID-19 compared to an EUA LDT.

... In this study, we showed that similar to ID NOW, the Accula SARS-CoV-2 test has a lower 135 sensitivity for diagnosis of COVID-19 compared to an EUA LDT. The false negatives obtained 136 from the Accula SARS-CoV-2 test were predominantly observed with low viral load specimens. 137 138 ...

Ref: Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens [bioRxiv, 2020-05-13]


Using SARS-CoV-2-positive clinical samples a variation of the 95 % limit of detection up to a 6-fold All rights reserved.

... Commercial RT-PCR diagnostic kits for COVID-19 have been compared before (5, 6) . Using SARS-CoV-2-positive clinical samples a variation of the 95 % limit of detection up to a 6-fold All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who ...

Ref: Analysis of external quality assessment samples revealed crucial performance differences between commercial RT-PCR assays for SARS-CoV-2 detection when taking extraction methods and real-time-PCR instruments into account [bioRxiv, 2020-09-23]


The test generated a high proportion of false positives due to initial development with faulty reagents.

... marketed tests that could lead individuals to falsely believe they were immune to COVID-19. 6 The test generated a high proportion of false positives due to initial development with faulty reagents. 10 Beyond quality control issues, the diagnostic test further suffered from a slow reporting of ...

Ref: Covid-19, Single-Sourced Diagnostic Tests, and Innovation Policy [J Law Biosci, 2020-07-07]


the sensitivity is limited.

... coronavirus disease 2019 (COVID-19) relies on clinical features and reverse-transcriptase polymerase chain reaction testing, but the sensitivity is limited. Carotid CTA is a routine acute stroke investigation and includes the lung apices. We evaluated ...

Ref: COVID-19 Stroke Apical Lung Examination Study: A Diagnostic and Prognostic Imaging Biomarker in Suspected Acute Stroke [AJNR am. j. neuroradiology, 2020]


The timely distribution of these diagnostic tests to medical institutions enabled early detection and self-isolation of confirmed COVID-19 cases.

... developed diagnostic kits for COVID-19, and emergency use authorization (EUA) for these kits was granted. The timely distribution of these diagnostic tests to medical institutions enabled early detection and self-isolation of confirmed COVID-19 cases. Based on cooperation among the government, local authorities, and the public, effective contact tracing and ...

Ref: Current laboratory diagnosis of coronavirus disease 2019 [Korean J Intern Med, 2020-07-01]


the overall sensitivity of 75% may reflect that some patients may not yet develop antibodies or will never develop

... IgG or IgM antibodies. On the one hand, in reference to IgM and IgG combination, the overall sensitivity of 75% may reflect that some patients may not yet develop antibodies or will never develop (the length of time from the symptoms onset to serological test ranged from 8 to ...

Ref: Diagnostic accuracy of an automated chemiluminescent immunoassay for anti‐SARS‐CoV‐2 IgM and IgG antibodies: an Italian experience [J Med Virol, 2020-05-10]


The early nucleic acid analysis of known pathogen panels led to negative results, suggesting the causative agent was of unknown origin.

... a cluster of patients with severe respiratory symptoms in Hubei Province, China, in December 2019. The early nucleic acid analysis of known pathogen panels led to negative results, suggesting the causative agent was of unknown origin. By early January 2020, analysis of bronchoalveolar lavage (BAL) fluid from infected patients revealed a ...

Ref: COVID-19 Serological Tests: How Well Do They Actually Perform? [Diagnostics (Basel), 2020-07-04]


COVID-19 illuminates the need for a tiered diagnostic approach to rapidly identify clinically significant infections and reduce disease spread.

... As such, there is uncertainty surrounding disease burden and community spread, severely hampering containment efforts. COVID-19 illuminates the need for a tiered diagnostic approach to rapidly identify clinically significant infections and reduce disease spread. Without the ability to efficiently screen patients, hospitals are overwhelmed, potentially delaying treatment for other ...

Ref: Multi-tiered screening and diagnosis strategy for COVID-19: a model for sustainable testing capacity in response to pandemic [Ann Med, 2020]


the detection sensitivity of POC rapid tests corresponded with the antibody dynamics and reached 100% after 3 weeks of symptom onset.

... tool in addition to rRT-PCR for the diagnosis of patients with COVID-19. In this study, the detection sensitivity of POC rapid tests corresponded with the antibody dynamics and reached 100% after 3 weeks of symptom onset. COVID-19 patients complicated with pneumonia exhibited earlier seroconversion than those without pneumonia. However, the presence ...

Ref: Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2 [J Infect, 2020-06-15]


even a high-sensitivity test may lead to a high percentage of false positive diagnoses,

... correctly diagnose one person, which is estimated by 1/PSI In a population with low prevalence, even a high-sensitivity test may lead to a high percentage of false positive diagnoses, resulting in the need for multiple high-cost tests to achieve a correct diagnosis Thus, basing ...

Ref: The Sky Has Its Limits in COVID-19 Testing [Rambam Maimonides medical journal, 2020]


While it is highly specific, there are reports of low sensitivity in the field [3, [5] [6] [7] .

... presence of SARS-CoV-2 in nasofaringeal swabs collected from patients suspected to be infected [4] . While it is highly specific, there are reports of low sensitivity in the field [3, [5] [6] [7] . The ability of the qRT-PCR to detect SARS-CoV-2 is dependent on the presence of the ...

Ref: Sensitivity and specificity of a rapid test for assessment of exposure to SARS-CoV-2 in a community-based setting in Brazil [Rambam Maimonides medical journal, 2020-05-10]


Diagnostic accuracy was determined in comparison to SARS-CoV-2 real time (RT)-PCR.

... using universal transport medium with nasopharyngeal (NP) and oropharyngeal (OP) swabs from suspected Covid-19 cases. Diagnostic accuracy was determined in comparison to SARS-CoV-2 real time (RT)-PCR. RESULTS: A total of 127 samples were included; 82 were RT-PCR positive. Median patients’ age ...

Ref: Evaluation of novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples [Int J Infect Dis, 2020-06-01]


Experimental results show that the proposed hybrid model can diagnose COVID-19 disease with high accuracy from chest X-ray images.

... coefficients in the feature matrix are optimized with the help of the CSSA and COVID-19 disease is diagnosed by the EfficientNet-B0 model, which is one of the deep learning methods. Experimental results show that the proposed hybrid model can diagnose COVID-19 disease with high accuracy from chest X-ray images. ...

Ref: Recognition of COVID-19 disease from X-ray images by hybrid model consisting of 2D curvelet transform, chaotic salp swarm algorithm and deep learning technique [Chaos Solitons Fractals, 2020]


The Euroimmun assay displays a nearly optimal diagnostic accuracy using IgG against SARS-CoV-2 in patient samples,

... for the manufacturer"s, improved assay performance, leaving 8.9% of IgG ratios indeterminate between 0.8-2.5. CONCLUSIONS: The Euroimmun assay displays a nearly optimal diagnostic accuracy using IgG against SARS-CoV-2 in patient samples, with no obvious gains from IgA serology. The optimized cut-offs are fit for rule-in and ...

Ref: Validation of a commercially available SARS-CoV-2 serological immunoassay [Clin Microbiol Infect, 2020]


Safely evaluating clinically stable persons for COVID-19 at traditional health care access points is resource intensive and slow, and risks exposing staff to infection.

... Safely evaluating clinically stable persons for COVID-19 at traditional health care access points is resource intensive and slow, and risks exposing staff to infection. Many jurisdictions are enabling innovative testing venues, such as external tents or drive-through or "phone booth" testing, as well as home assessment teams to expedite specimen collection while limiting potential ...

Ref: Diagnostic Testing for Severe Acute Respiratory Syndrome–Related Coronavirus-2: A Narrative Review [Ann Intern Med, 2020-04-13]


The highest percentage positive result rate (n = 5, 80%) was to identify convalescent plasma donors.

... with a resolved COVID-19compatible illness (n = 105, 24%) who never had a molecular test. The highest percentage positive result rate (n = 5, 80%) was to identify convalescent plasma donors. No testing was done on patients to determine vaccine response (ie, indication E), owing to ...

Ref: Clinical Ordering Practices of the SARS-CoV-2 Antibody Test at a Large Academic Medical Center [Open Forum Infect Dis, 2020-10-09]


their accuracy has usually been assessed using very few samples, and rigorous comparisons between these tests are scarce.

... Numerous SARS-CoV-2 rapid serological tests have been developed, but their accuracy has usually been assessed using very few samples, and rigorous comparisons between these tests are scarce. In this study, we evaluated and compared 10 commercially-available SARS-CoV-2 rapid serological tests using the STARD methodology (Standards for Reporting of ...

Ref: Evaluating ten commercially-available SARS-CoV-2 rapid serological tests using the STARD (Standards for Reporting of Diagnostic Accuracy Studies) method. [Open Forum Infect Dis, 2020-09-11]


the diagnostic accuracy of the QIAstat-Dx Respiratory SARS-CoV-2 Panel assay was found to be high,

... In this study, the diagnostic accuracy of the QIAstat-Dx Respiratory SARS-CoV-2 Panel assay was found to be high, and initiating point-of-care testing alongside laboratory PCR alerted us to the poor sensitivity of the nationally recommended PHE RdRp screening assay early in the course of the ...

Ref: Clinical impact of molecular point-of-care testing for suspected COVID-19 in hospital (COV-19POC): a prospective, interventional, non-randomised, controlled study [Lancet Respir Med, 2020-10-08]


Sensitivity of FebriDx for the identification of COVID-19 was 93% (110/118; 95% CI 87 to 97%)

... hours with point-of-care PCR testing and 23.4 (17.2 to 31.1) hours with laboratory PCR testing. Sensitivity of FebriDx for the identification of COVID-19 was 93% (110/118; 95% CI 87 to 97%) and specificity was 86% (112/130; 95%CI 79 to 92%). Positive and negative likelihood ratios were ...

Ref: Diagnostic accuracy of the FebriDx host response point-of-care test in patients hospitalised with suspected COVID-19 [J Infect, 2020]