scholarly journals Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid and antibody tests up to 22 August 2020

2021 ◽  
Vol 26 (45) ◽  
Author(s):  
Ivo Van Walle ◽  
Katrin Leitmeyer ◽  
Eeva K Broberg ◽  
Keyword(s):  
Nucleic Acid ◽  
Confidence Interval ◽  
Clinical Performance ◽  
Point Of Care ◽  
Test Results ◽  
Interval Width ◽  
Point Of Care Tests ◽  
Antibody Tests ◽  
Confidence Interval Width ◽  
Nucleic Acid Tests

Background Reliable testing for SARS-CoV-2 is key for the management of the COVID-19 pandemic. Aim We estimate diagnostic accuracy for nucleic acid and antibody tests 5 months into the COVID-19 pandemic, and compare with manufacturer-reported accuracy. Methods We reviewed the clinical performance of SARS-CoV-2 nucleic acid and antibody tests based on 93,757 test results from 151 published studies and 20,205 new test results from 12 countries in the European Union and European Economic Area (EU/EEA). Results Pooling the results and considering only results with 95% confidence interval width ≤ 5%, we found four nucleic acid tests, including one point-of-care test and three antibody tests, with a clinical sensitivity ≥ 95% for at least one target population (hospitalised, mild or asymptomatic, or unknown). Nine nucleic acid tests and 25 antibody tests, 12 of them point-of-care tests, had a clinical specificity of ≥ 98%. Three antibody tests achieved both thresholds. Evidence for nucleic acid point-of-care tests remains scarce at present, and sensitivity varied substantially. Study heterogeneity was low for eight of 14 sensitivity and 68 of 84 specificity results with confidence interval width ≤ 5%, and lower for nucleic acid tests than antibody tests. Manufacturer-reported clinical performance was significantly higher than independently assessed in 11 of 32 and four of 34 cases, respectively, for sensitivity and specificity, indicating a need for improvement in this area. Conclusion Continuous monitoring of clinical performance within more clearly defined target populations is needed.

scholarly journals Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid, antigen and antibody tests up to 22 August 2020

2020 ◽  
Author(s):  
Ivo Van Walle ◽  
Katrin Leitmeyer ◽  
Eeva K Broberg ◽  
Keyword(s):  
Nucleic Acid ◽  
Confidence Interval ◽  
Clinical Performance ◽  
Point Of Care ◽  
Test Results ◽  
Interval Width ◽  
Point Of Care Tests ◽  
Antibody Tests ◽  
Confidence Interval Width ◽  
Nucleic Acid Tests

We reviewed the clinical performance of SARS-CoV-2 nucleic acid, viral antigen and antibody tests based on 94739 test results from 157 published studies and 20205 new test results from 12 EU/EEA Member States. Pooling the results and considering only results with 95% confidence interval width ≤5%, we found 4 nucleic acid tests, among which 1 point of care test, and 3 antibody tests with a clinical sensitivity ≤95% for at least one target population (hospitalised, mild or asymptomatic, or unknown). Analogously, 9 nucleic acid tests and 25 antibody tests, among which 12 point of care tests, had a clinical specificity of ≤98%. Three antibody tests achieved both thresholds. Evidence for nucleic acid and antigen point of care tests remains scarce at present, and sensitivity varied substantially. Study heterogeneity was low for 8/14 (57.1%) sensitivity and 68/84 (81.0%) specificity results with confidence interval width ≤5%, and lower for nucleic acid tests than antibody tests. Manufacturer reported clinical performance was significantly higher than independently assessed in 11/32 (34.4%) and 4/34 (11.8%) cases for sensitivity and specificity respectively, indicating a need for improvement in this area. Continuous monitoring of clinical performance within more clearly defined target populations is needed.

scholarly journals Nitrocellulose-bound achromopeptidase for point-of-care nucleic acid tests

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Georgios Chondrogiannis ◽  
Shirin Khaliliazar ◽  
Anna Toldrà ◽  
Pedro Réu ◽  
Mahiar M. Hamedi
Keyword(s):  
Nucleic Acid ◽  
Sample Preparation ◽  
Point Of Care ◽  
Dna Amplification ◽  
Recombinase Polymerase Amplification ◽  
Gram Positive ◽  
Gram Positive Bacteria ◽  
Enzymatic Function ◽  
Modern Biotechnology ◽  
Nucleic Acid Tests

AbstractEnzymes are the cornerstone of modern biotechnology. Achromopeptidase (ACP) is a well-known enzyme that hydrolyzes a number of proteins, notably proteins on the surface of Gram-positive bacteria. It is therefore used for sample preparation in nucleic acid tests. However, ACP inhibits DNA amplification which makes its integration difficult. Heat is commonly used to inactivate ACP, but it can be challenging to integrate heating into point-of-care devices. Here, we use recombinase polymerase amplification (RPA) together with ACP, and show that when ACP is immobilized on nitrocellulose paper, it retains its enzymatic function and can easily and rapidly be activated using agitation. The nitrocellulose-bound ACP does, however, not leak into the solution, preventing the need for deactivation through heat or by other means. Nitrocellulose-bound ACP thus opens new possibilities for paper-based Point-of-Care (POC) devices.

scholarly journals Assessment of the Field Utility of a Rapid Point-of-Care Test for SARS-CoV-2 Antibodies in a Household Cohort

2021 ◽  
Author(s):  
Mehal Churiwal ◽  
Kelly D. Lin ◽  
Salman Khan ◽  
Srijana Chhetri ◽  
Meredith S. Muller ◽  
...  
Keyword(s):  
Cohort Study ◽  
Confidence Interval ◽  
Point Of Care ◽  
Natural Infection ◽  
Field Performance ◽  
Antibody Test ◽  
Asymptomatic Infection ◽  
Point Of Care Test ◽  
Antibody Tests ◽  
Rapid Antibody

Point-of-care (POC) tests to detect SARS-CoV-2 antibodies offer quick assessment of serostatus after natural infection or vaccination. We compared the field performance of the BioMedomics COVID-19 IgM/IgG Rapid Antibody Test against an ELISA in 303 participants enrolled in a SARS-CoV-2 household cohort study. The rapid antibody test was easily implemented with consistent interpretation across 14 users in a variety of field settings. Compared with ELISA, detection of seroconversion lagged by 5 to 10 days. However, it retained a sensitivity of 90% (160/177, 95% confidence interval [CI] 85–94%) and specificity of 100% (43/43, 95% CI 92–100%) for those tested 3 to 5 weeks after symptom onset. Sensitivity was diminished among those with asymptomatic infection (74% [14/19], 95% CI 49–91%) and early in infection (45% [29/64], 95% CI 33–58%). When used appropriately, rapid antibody tests offer a convenient way to detect symptomatic infections during convalescence.

scholarly journals Clinical validation of a point-of-care antibody test for COVID-19

2020 ◽  
Author(s):  
Monila Patel ◽  
Yogesh Lakhotia ◽  
Sneha Shah ◽  
Nilay Suthar ◽  
Cherry Shah ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Sensitivity And Specificity ◽  
Significant Role ◽  
Point Of Care ◽  
Antibody Test ◽  
Lateral Flow ◽  
Clinical Validation ◽  
Rt Pcr ◽  
Antibody Tests ◽  
Spike Proteins

AbstractThe objective of this study was to evaluate the performance of a lateral flow antibody test for COVID-19, approved for use in India. Although many point-of-care antibody tests are available globally, they have been subjected to limited clinical validation. This has led to suboptimal outcomes in the field, where antibody tests play a significant role in tracking the immunity of individuals and communities. In this study an antibody test, ImmunoQuick that recognizes antibodies to the Nucleocapsid and Spike proteins of SARS CoV-2 was tested in 100 symptomatic patients with a positive or negative diagnosis of COVID-19, based on RT-PCR results. The overall sensitivity of the test was found to be 86.1% (95% CI: 76.4% to 92.8%) and specificity 100% (95% confidence interval: 73.5% to 100%). The sensitivity reached a peak of 95.7% with samples taken 17 days after the onset of symptoms. Overall, the sensitivity and specificity of the test are sufficient for assessing seroprevalence.

scholarly journals Rapid Tests for the Diagnosis of Viral Infections

2021 ◽  
Vol 96 (5) ◽  
pp. 415-420
Author(s):  
Hyun Soo Kim
Keyword(s):  
Nucleic Acid ◽  
Diagnostic Tests ◽  
Viral Infections ◽  
Rapid Test ◽  
Test Results ◽  
Test Items ◽  
Rapid Tests ◽  
Antigen Tests ◽  
Antibody Tests ◽  
Rapid Antibody

Rapid and accurate diagnostic tests for viral infections are essential for diagnosis, treatment, and patient isolation. Various rapid nucleic acid tests, rapid antigen tests, and rapid antibody tests have been developed and used to diagnose viral infections. In this paper, the types and characteristics of various rapid viral tests currently used in Korea, test items, and considerations when interpreting rapid test results are described.

Investigations and microscopy

2019 ◽  
pp. 63-80
Keyword(s):  
Nucleic Acid ◽  
Laboratory Testing ◽  
Trichomonas Vaginalis ◽  
Point Of Care ◽  
Rapid Test ◽  
The Other ◽  
Nucleic Acid Amplification ◽  
Blood Samples ◽  
Dark Ground ◽  
Point Of Care Tests

This chapter covers investigations and tests commonly used in sexual health. Some investigations can be performed on-site as the patient waits, such as urinalysis, pregnancy tests, and increasingly available point of care tests for infections such as HIV and, less commonly, the other blood-borne viruses, syphilis, Trichomonas vaginalis. On-site microscopy helps with diagnosis of genital candidiasis, bacterial vaginosis, N. gonorrhoeae infection, and T. vaginalis. Other investigations require sending samples away for laboratory testing of genital or ulcer swab, urine, or blood samples for STI and blood-borne viruses. This chapter explains the use of light and dark ground microscopy, near patient rapid test technologies, molecular methods such as nucleic acid amplification, culture and serology. Sensitivities and specificities of commonly available test kits are included.

Current State of Commercial Point-of-Care Nucleic Acid Tests for Infectious Diseases

The Analyst ◽  
2021 ◽  
Author(s):  
Jane Zhang ◽  
Andrew T. Bender ◽  
David S. Boyle ◽  
Paul K Drain ◽  
Jonathan D. Posner
Keyword(s):  
Nucleic Acid ◽  
Infectious Diseases ◽  
Point Of Care ◽  
Current State ◽  
Nucleic Acid Tests

The COVID-19 pandemic has put the spotlight on the urgent need for integrated nucleic acid tests (NATs) for infectious diseases, especially those that can be used near patient (“point-of-care”, POC),...

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