scholarly journals Automated molecular testing of saliva for SARS-CoV-2 detection

2020 ◽  
Author(s):  
Nancy Matic ◽  
Tanya Lawson ◽  
Gordon Ritchie ◽  
Aleksandra Stefanovic ◽  
Victor Leung ◽  
...  
Keyword(s):  
High Throughput ◽  
Turnaround Time ◽  
Molecular Testing ◽  
Cross Contamination ◽  
Plasma Samples ◽  
Test Results ◽  
Clinical Laboratories ◽  
Viral Transport ◽  
Global Demand ◽  
Phosphate Buffered Saline

Introduction: With surging global demand for increased SARS-CoV-2 testing capacity, clinical laboratories seek automated, high-throughput molecular solutions, particularly for specimen types which do not rely upon supply of specialized collection devices or viral transport media (VTM). Saliva was evaluated as a diagnostic specimen for SARS-CoV-2 using the cobas SARS-CoV-2 Test on the cobas 6800 instrument. Methods: Saliva specimens submitted from various patient populations under investigation for COVID-19 from March-July 2020 were processed in the laboratory with sterile phosphate-buffered saline in a 1:2 dilution and vortexed with glass beads. The processed saliva samples were tested using a commercial assay for detection of the SARS-CoV-2 E gene (LightMix) in comparison to the cobas SARS-CoV-2 Test. Results: 22/64 (34.4%) of the saliva samples were positive for SARS-CoV-2. Positive and negative concordance between the LightMix and cobas assays were 100%. There was no cross-contamination of samples observed on the cobas 6800. The overall invalid rate for saliva on the cobas 6800 (1/128, 0.78%) was similar to the baseline invalid rate observed for nasopharyngeal swabs/VTM and plasma samples. Conclusions: Saliva is a feasible specimen type for SARS-CoV-2 testing on the cobas 6800, with potential to improve turnaround time and enhance testing capacity.

scholarly journals On-site rapid molecular testing, mobile sampling teams and eHealth to support primary care physicians during the COVID-19 pandemic

2020 ◽  
Author(s):  
N.N. Cheung ◽  
S.A. Boers ◽  
S. Kiani deh Kiani ◽  
R.W. Jansen ◽  
D.O. Mook-Kanamori ◽  
...  
Keyword(s):  
Primary Care Physicians ◽  
Turnaround Time ◽  
University Hospital ◽  
Nasopharyngeal Swab ◽  
Molecular Testing ◽  
Testing Time ◽  
Test Results ◽  
Routine Testing ◽  
Time Stamps ◽  
The Moment

AbstractObjectivesWe evaluated the effects of on-site rapid molecular testing at a drive-through sampling facility, deployment of mobile sampling teams and implementation of an online eHealth platform as supportive measures for general practitioners (GPs) during the COVID-19 pandemic.MethodsAn eHealth platform was developed that allowed GPs to either refer patients to a drive-through sampling facility or to request a home visit by a sampling team. Nasopharyngeal swab samples from patients marked as urgent (n=333) were tested immediately on-site using a GeneXpert System. Non-urgent samples (n=1,460) were sent once a day to a university hospital laboratory for routine testing. Time stamps starting from referral to the moment of test report sent were recorded to calculate the turnaround time.ResultsThe eHealth platform was rapidly adopted and used by a total of 517 GPs to test 1,793 patients in a period of 13 weeks. On-site rapid molecular testing reduced the median turnaround time to 03h:41m compared to 29h:15m for routine testing. Positive SARS-CoV-2 test results were identified amongst 84/1,477 (5.7%) and 33/316 (10.4%) patients sampled at the drive-through or at home, respectively. In the age category of >80 years, 80.4% of patients were tested by a mobile sampling team.ConclusionsThe combination of rapid molecular testing and eHealth reduced the time between referral and results sent back to the GP to less than four hours. In addition, mobile sampling teams helped in reaching non-mobile, elderly patient populations with a higher prevalence of COVID-19.

scholarly journals Making sense of rapid antigen testing in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostics

Diagnosis ◽  
2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Camilla Mattiuzzi ◽  
Brandon M. Henry ◽  
Giuseppe Lippi
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Point Of Care ◽  
Turnaround Time ◽  
Molecular Testing ◽  
Upper Respiratory Tract ◽  
Making Sense ◽  
Skilled Personnel ◽  
Potential Benefits ◽  
Antigen Testing ◽  
Care Availability

AbstractAlthough the most effective strategy for preventing or containing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreaks relies on early diagnosis, the paramount and unprecedented number of tests needed to fully achieve this target is overwhelming worldwide testing supply and capacity. Molecular detection of SARS-CoV-2 RNA in nasopharyngeal swabs is still considered the reference diagnostic approach. Nonetheless, identification of SARS-CoV-2 proteins in upper respiratory tract specimens and/or saliva by means of rapid (antigen) immunoassays is emerging as a promising screening approach. These tests have some advantages compared to molecular analysis, such as point of care availability, no need of skilled personnel and dedicated instrumentation, lower costs and short turnaround time. However, these advantages are counterbalanced by lower diagnostic sensitivity compared to molecular testing, which would only enable to identifying patients with higher SARS-CoV-2 viral load. The evidence accumulated to-date has hence persuaded us to develop a tentative algorithm, which would magnify the potential benefits of rapid antigen testing in SARS-CoV-2 diagnostics.

What Every Neuropathologist Needs to Know: Practical Aspects and Pitfalls in Molecular Diagnosis of Brain Tumors

2021 ◽  
Author(s):  
J Stephen Nix ◽  
Cristiane M Ida
Keyword(s):  
Brain Tumors ◽  
Molecular Diagnosis ◽  
Genetic Alterations ◽  
Genetic Alteration ◽  
Molecular Testing ◽  
Test Results ◽  
Molecular Test ◽  
Molecular Tests ◽  
Clinically Significant ◽  
Selection Of

Abstract Molecular testing has become part of the routine diagnostic workup of brain tumors after the implementation of integrated histomolecular diagnoses in the 2016 WHO classification update. It is important for every neuropathologist to be aware of practical preanalytical, analytical, and postanalytical factors that impact the performance and interpretation of molecular tests. Prior to testing, optimizing tumor purity and tumor amount increases the ability of the molecular test to detect the genetic alteration of interest. Recognizing basic molecular testing platform analytical characteristics allows selection of the optimal platform for each clinicopathological scenario. Finally, postanalytical considerations to properly interpret molecular test results include understanding the clinical significance of the detected genetic alteration, recognizing that detected clinically significant genetic alterations are occasionally germline constitutional rather than somatic tumor-specific, and being cognizant that recommended and commonly used genetic nomenclature may differ. Potential pitfalls in brain tumor molecular diagnosis are also discussed.

scholarly journals Protocol to analyze circulating small non-coding RNAs by high-throughput RNA sequencing from human plasma samples

2021 ◽  
Vol 2 (3) ◽  
pp. 100606
Author(s):  
Giuseppina E. Grieco ◽  
Guido Sebastiani ◽  
Daniela Fignani ◽  
Noemi Brusco ◽  
Laura Nigi ◽  
...  
Keyword(s):  
Human Plasma ◽  
Rna Sequencing ◽  
High Throughput ◽  
Plasma Samples ◽  
Human Plasma Samples ◽  
Non Coding Rnas

Requiem for the STAT Test: Automation and Point of Care Testing

2019 ◽  
Author(s):  
Gurmukh Singh ◽  
Natasha M Savage ◽  
Brandy Gunsolus ◽  
Kellie A Foss
Keyword(s):  
Point Of Care ◽  
Turnaround Time ◽  
Test Automation ◽  
Test Results ◽  
Point Of Care Testing ◽  
Tube System ◽  
Front End ◽  
Laboratory Test Results ◽  
Batch Testing ◽  
Pneumatic Tube System

Abstract Objective Quick turnaround of laboratory test results is needed for medical and administrative reasons. Historically, laboratory tests have been requested as routine or STAT. With a few exceptions, a total turnaround time of 90 minutes has been the usually acceptable turnaround time for STAT tests. Methods We implemented front-end automation and autoverification and eliminated batch testing for routine tests. We instituted on-site intraoperative testing for selected analytes and employed point of care (POC) testing judiciously. The pneumatic tube system for specimen transport was expanded. Results The in-laboratory turnaround time was reduced to 45 minutes for more than 90% of tests that could reasonably be ordered STAT. With rare exceptions, the laboratory no longer differentiates between routine and STAT testing. Having a single queue for all tests has improved the efficiency of the laboratory. Conclusion It has been recognized in manufacturing that batch processing and having multiple queues for products are inefficient. The same principles were applied to laboratory testing, which resulted in improvement in operational efficiency and elimination of STAT tests. We propose that the target for in-laboratory turnaround time for STAT tests, if not all tests, be 45 minutes or less for more than 90% of specimens.

Reporting altered test results in hemolyzed samples: is the cure worse than the disease?

2017 ◽  
Vol 55 (8) ◽  
pp. 1112-1114 ◽  
Author(s):  
Giuseppe Lippi ◽  
Gianfranco Cervellin ◽  
Mario Plebani
Keyword(s):  
Laboratory Data ◽  
Turnaround Time ◽  
Reliable Data ◽  
Test Results ◽  
The Past ◽  
Laboratory Test Results ◽  
Performance Specifications ◽  
Life Threatening ◽  
The Many ◽  
Definition Of

AbstractThe management of laboratory data in unsuitable (hemolyzed) samples remains an almost unresolved dilemma. Whether or not laboratory test results obtained by measuring unsuitable specimens should be made available to the clinicians has been the matter of fierce debates over the past decades. Recently, an intriguing alternative to suppressing test results and recollecting the specimen has been put forward, entailing the definition and implementation of specific algorithms that would finally allow reporting a preanalytically altered laboratory value within a specific comment about its uncertainty of measurement. This approach carries some advantages, namely the timely communication of potentially life-threatening laboratory values, but also some drawbacks. These especially include the challenging definition of validated performance specifications for hemolyzed samples, the need to producing reliable data with the lowest possible uncertainty, the short turnaround time for repeating most laboratory tests, the risk that the comments may be overlooked in short-stay and frequently overcrowded units (e.g. the emergency department), as well as the many clinical advantages of a direct communication with the physician in charge of the patient. Despite the debate remains open, we continue supporting the suggestion that suppressing data in unsuitable (hemolyzed) samples and promptly notifying the clinicians about the need to recollect the samples remains the most (clinically and analytically) safe practice.

scholarly journals Guidance for laboratories performing molecular pathology for cancer patients

2014 ◽  
Vol 67 (11) ◽  
pp. 923-931 ◽  
Author(s):  
Ian A Cree ◽  
Zandra Deans ◽  
Marjolijn J L Ligtenberg ◽  
Nicola Normanno ◽  
Anders Edsjö ◽  
...  
Keyword(s):  
Molecular Pathology ◽  
Rna Extraction ◽  
Internal Audit ◽  
Turnaround Time ◽  
Careful Consideration ◽  
Internal Quality ◽  
Molecular Testing ◽  
Pathology Report ◽  
Sufficient Information ◽  
Dna And Rna

Molecular testing is becoming an important part of the diagnosis of any patient with cancer. The challenge to laboratories is to meet this need, using reliable methods and processes to ensure that patients receive a timely and accurate report on which their treatment will be based. The aim of this paper is to provide minimum requirements for the management of molecular pathology laboratories. This general guidance should be augmented by the specific guidance available for different tumour types and tests. Preanalytical considerations are important, and careful consideration of the way in which specimens are obtained and reach the laboratory is necessary. Sample receipt and handling follow standard operating procedures, but some alterations may be necessary if molecular testing is to be performed, for instance to control tissue fixation. DNA and RNA extraction can be standardised and should be checked for quality and quantity of output on a regular basis. The choice of analytical method(s) depends on clinical requirements, desired turnaround time, and expertise available. Internal quality control, regular internal audit of the whole testing process, laboratory accreditation, and continual participation in external quality assessment schemes are prerequisites for delivery of a reliable service. A molecular pathology report should accurately convey the information the clinician needs to treat the patient with sufficient information to allow for correct interpretation of the result. Molecular pathology is developing rapidly, and further detailed evidence-based recommendations are required for many of the topics covered here.

scholarly journals Validation of the Procalcitonin Assay on the Abbott Architect i1000

2019 ◽  
Vol 3 (6) ◽  
pp. 936-942 ◽  
Author(s):  
Jayson V Pagaduan ◽  
Estella Tam ◽  
Sridevi Devaraj
Keyword(s):  
Statistical Analysis ◽  
Method Validation ◽  
Turnaround Time ◽  
Good Precision ◽  
Serum Samples ◽  
Diagnostic Use ◽  
Clinical Laboratories ◽  
The Us ◽  
The Impact ◽  
Abbott Architect

Abstract Background Procalcitonin (PCT) is an emerging biomarker for detecting sepsis. Recently, the US Food and Drug Administration cleared the expanded use of this biomarker for guiding clinicians regarding antibiotic treatment. To our knowledge, there are no published method validations for the Abbott Architect PCT assay. This article will discuss the process of method validation of the B·R·A·H·M·S PCT assay on the Abbott Architect platform. Methods We studied the precision, accuracy, and linearity of the Architect method following the guidance of the Clinical and Laboratory Standards Institute EP5-A2 document. Furthermore, we also tested the impact of major sources of interference from hemolysate, lipoproteins, and bilirubin. To validate the Architect method, we compared patients' serum PCT measurements with our previously established Mini VIDAS (bioMerieux) PCT assay. Results Statistical analysis showed that the 2 assays have good correlation (r > 0.99), slope of 1.023, and intercept of −0.760. The calculated bias is −7.435%. The Architect method showed good precision with %CV < 3.5% for both interassay and intraassay compared with %CV < 6.5% for Mini VIDAS, which was previously determined at our institution. No bias >10% was observed with the Architect method when pooled serum samples were spiked with interferants. The turnaround time for both platforms was the same (20 min); however, in contrast with Mini VIDAS, the Architect system has automated pipetting of samples and can perform multiple assays simultaneously. Conclusion These results showed that the Architect B·R·A·H·M·S PCT assay has analytical characteristics conducive for diagnostic use in clinical laboratories. Our method validation report will be beneficial for other institutions to adapt this assay on existing Abbott Architect i1000 immunoassay analyzers.

scholarly journals COVID-19 related challenges faced by Medical Laboratory Staff: A Review of Literature

2021 ◽  
Vol 12 (2) ◽  
pp. 232-237
Author(s):  
Jignesh Sharma ◽  
Richard D. Nair
Keyword(s):  
Human Resources ◽  
Laboratory Testing ◽  
English Language ◽  
Turnaround Time ◽  
Medical Laboratory ◽  
Test Results ◽  
Review Of Literature ◽  
Medical Laboratory Science ◽  
Laboratory Staff ◽  
Laboratory Science

Laboratory testing on the confirmation of COVID-19 results is an essential component and without the expertise of trained laboratory technicians this is not possible. The aim of this study was to review the impacts of COVID-19 on medical laboratory staff. The literature search was done using Medline, Embase, Scopus, and Proquest databases, and relevant keywords were applied to find studies which have been conducted in the field of Medical Laboratory Science specifically looking at the impacts on staff caused by the Covid-19 pandemic. All the studies pertaining to the topic published in 2020 and 2021 in English language were reviewed and the main themes were identified. The results showed that impacts of COVID-19 were felt by the staff, as they were pushed to their limits causing stress and burnout. Apart from this laboratory staff were faced with issues such as; shortage in terms of human resources, consumables, testing kits and reagents. This was an added factor to delays in testing and disruption to the testing Turnaround time (TATs) and also contributed to the stress and burnout of staff. Laboratory professionals and other health care staffs were pushed to the limits to ensure patient care was not affected and each patient was attended too without delay. Laboratory personnel’s were pushed to their limits to ensure that test results were given on time.

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