Types of Assays for SARS-CoV-2 Testing: A Review

Abstract Clinical laboratory testing routinely provides actionable results, which help direct patient care in the inpatient and outpatient settings. Since December 2019, a novel coronavirus (SARS-CoV-2) has been causing disease (COVID-19 [coronavirus disease 2019]) in patients, beginning in China and now extending worldwide. In this context of a novel viral pandemic, clinical laboratories have developed multiple novel assays for SARS-CoV-2 diagnosis and for managing patients afflicted with this illness. These include molecular and serologic-based tests, some with point-of-care testing capabilities. Herein, we present an overview of the types of testing available for managing patients with COVID-19, as well as for screening of potential plasma donors who have recovered from COVID-19.

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CDC and Clinical Laboratory Partners: Analysis of Biosafety Gaps Revealed During the Ebola Outbreak

American Journal of Clinical Pathology ◽

10.1093/ajcp/aqz128.001 ◽

2019 ◽

Vol 152 (Supplement_1) ◽

pp. S139-S139

Author(s):

Nancy Cornish ◽

Sheldon Campbell ◽

Elizabeth Weirich

Keyword(s):

Patient Care ◽

Health Care Providers ◽

Laboratory Testing ◽

Clinical Laboratory ◽

The United States ◽

Future Research ◽

Competency Assessment ◽

Care Providers ◽

Clinical Laboratories ◽

Clinical Laboratory Testing

Abstract Objectives Patient care and public health in the United States depend on timely and reliable clinical laboratory testing. A third of the roughly 500 million yearly patient visits to health care providers involve at least one laboratory test, and approximately 70% of medical decisions are based upon test results. However, the performance of clinical laboratory testing could be compromised by patient specimens potentially contaminated with highly infectious materials. The importance of biosafety in clinical laboratories was highlighted during the 2014 Ebola crisis, where fears about safety resulted in some institutions refusing or delaying tests on patient specimens, which resulted in delayed diagnoses and contributed to patient deaths. Methods In collaboration with subject matter experts from academia, medical centers, and federal institutions, the Centers for Disease Control and Prevention has reviewed the capability of clinical laboratories to safely test patient specimens potentially contaminated with highly infectious materials, like Ebola. Current biosafety guidance for clinical laboratories has been largely based on biosafety practices in research laboratories, so the guidelines do not always correspond to clinical laboratories and may be incomplete or occasionally inconsistent. While essential to patient care, clinical laboratories are also unique environments with specialized equipment, processes, and therefore distinct challenges. Here we discuss the complexity of clinical laboratories and describe how applying current biosafety guidance to clinical laboratories may be difficult and confusing at best or inappropriate and harmful at worst. We describe biosafety gaps and opportunities for improvement in the areas of ethics; risk assessment and management; automated and manual laboratory disciplines; specimen collection, processing, and storage; test utilization; waste management; laboratory personnel training and competency assessment; and accreditation processes. Conclusion These identified gaps in knowledge and practice could inform future research and education in clinical laboratory biosafety.

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Current nursing practice of point-of-care laboratory diagnostic testing in critical care units

American Journal of Critical Care ◽

10.4037/ajcc1995.4.6.429 ◽

1995 ◽

Vol 4 (6) ◽

pp. 429-434 ◽

Cited By ~ 20

Author(s):

Lamb LSJr ◽

RS Parrish ◽

SF Goran ◽

MH Biel

Keyword(s):

Critical Care ◽

Patient Care ◽

Laboratory Testing ◽

Point Of Care ◽

Diagnostic Testing ◽

Critical Care Nurses ◽

Point Of Care Testing ◽

Critical Care Units ◽

In Vitro Diagnostic

BACKGROUND: The development of user-friendly laboratory analyzers, combined with the need for rapid assessment of critically ill patients, has led to the performance of in vitro diagnostic testing at the point of care by personnel without formal laboratory training. OBJECTIVES: To determine the range of laboratory testing performed by critical care nurses and their attitudes toward this role. METHODS: A survey of critical care nursing consultants was conducted, using a modified Likert scale, to assess objective measures of point-of-care testing practice in critical care units and to determine nurses' attitudes toward the practice of point-of-care testing. Statistical analysis was performed to determine significant trends in responses. RESULTS: Of the units responding to the survey, 35% used critical care nurses exclusively to perform point-of-care testing, 32.5% used laboratory technicians and critical care nurses, and 25% used other personnel. Of critical care nurses performing laboratory testing, 95.5% performed blood glucose analysis; 18.7%, arterial blood gas analysis; 4.5%, electrolyte analysis; 4.5%, hematology profiles; and 22.7%, other testing. Most agreed that stat tests were not reported promptly, thereby necessitating bedside testing. Respondents indicated that they would prefer that laboratory personnel operate in vitro diagnostic equipment and that requirements for critical care nurses to perform laboratory testing detracted from other patient care duties. CONCLUSIONS: Most nurses who perform point-of-care testing responded that it was necessary and helpful in patient management. However, they would prefer, because of their other patient care responsibilities, that laboratory personnel take this responsibility.

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Prospective risk analysis adjusted to the reality of clinical and fertility laboratory processes

Diagnosis ◽

10.1515/dx-2015-0027 ◽

2015 ◽

Vol 2 (4) ◽

pp. 235-243 ◽

Cited By ~ 1

Author(s):

Pim M.W. Janssens ◽

Anja Scholten ◽

Harm De Waard ◽

Natascha Tiemens ◽

Monique Van Uum ◽

...

Keyword(s):

Risk Analysis ◽

Laboratory Testing ◽

Clinical Laboratory ◽

Practical Application ◽

Laboratory Practice ◽

Effect Analysis ◽

Clinical Laboratories ◽

Prospective Risk ◽

Fmea Method ◽

Clinical Laboratory Testing

AbstractProspective risk analysis (PRA) is a valuable instrument in quality assurance. The practical application of PRA in clinical laboratories according to the method we have described elsewhere leaves room for a number of adaptations to make it more applicable to and consistent with actual laboratory processes.We distinguished between more and less critical tests and products in the laboratory processes and scored the consequences of failures at different steps in line with the previously described failure type and effect analysis (FMEA) method. PRA was carried out for two typical laboratory processes: standard clinical laboratory testing and the cryopreservation of semen.Tests in standard clinical laboratory in processes were labeled critical, semi-critical or non-critical. Consequence scoring (C) and assessed risk (R) were significantly higher for processes containing tests considered to be critical (C=6.6±1.5, R=19.3±13.5) as compared to processes containing tests considered semi- or non-critical (C=3.0±1.4, R=8.2±5.3 and C=3.2±1.8, R=8.6±5.9, respectively). There were no differences in the C and R scores for processes with tests considered semi- or non-critical. In the semen cryopreservation process, a distinction between the processes involving private semen and generally accessible semen was made. The C scores for these were significantly different (C=5.9±2.2 and 5.0±2.0, respectively), the R scores did not differ.Introduction of a test criticality classification for the purpose of consequence scoring led to an improved PRA methodology, better reflecting the reality of clinical laboratory practice. We found that two levels of criticality, critical and less critical, were sufficient to achieve this improvement.

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“On Vivo” and Wearable Clinical Laboratory Testing Devices for Emergency and Critical Care Laboratory Testing

The Journal of Applied Laboratory Medicine ◽

10.1373/jalm.2018.028654 ◽

2019 ◽

Vol 4 (2) ◽

pp. 254-263 ◽

Cited By ~ 2

Author(s):

Alan H B Wu

Keyword(s):

Laboratory Testing ◽

Clinical Laboratory ◽

Point Of Care ◽

Surgical Excision ◽

Turnaround Time ◽

Test Results ◽

Next Generation ◽

Laboratory Test Results ◽

Blood Gas Analyses ◽

Clinical Laboratory Testing

Abstract Background Point-of-care testing (POCT) devices are designed for clinical laboratory testing at the bedside or near the patient and can significantly reduce the turnaround time for laboratory test results. The next generation for clinical laboratory testing may be devices that are worn or attached to the patient. Content POCT devices that are designed where samples are tested directly on the patient include bilirubinometers, pulse oximeters, breathalyzers (for alcohol and, more recently, cannabinoid detection), transcutaneous blood gas analyses, and novel testing applications such as glucose and tumor signatures following surgical excision. The utility of these devices with special reference for use within the intensive care unit and the emergency department is reviewed. Summary It is likely that wearable POCT devices will be developed in the future that can meet current and emerging clinical needs. Advancements in biomedical engineering and information technology will be needed in the creation of next-generation devices.

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