Quality assurance practices for point of care testing programs: Recommendations by the Canadian society of clinical chemists point of care testing interest group

Venner, Allison A.; Beach, Lori; Shea, Jennifer; Knauer, Michael J.; Yun, Huang; Fung, Angela W.S.; Dalton, James; Provençal, Mathieu; Shaw, Julie

doi:10.1016/j.clinbiochem.2020.11.008

Cited by 21 publications

(11 citation statements)

References 20 publications

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“…There is also a need for quality assurance interventions such as training to manage the accuracy and subsequent availability of REASSURED POC diagnostic tests. To ensure the quality of POC tests, both skilled and non-skilled test handlers should be trained to use POC tests competently [5]. Accurate diagnosis will ensures that patients are treated correctly and that disease surveillance is trustworthy [34].…”

Section: Discussionmentioning

confidence: 99%

“…Point-of-care (POC) diagnostic tests are medical tests conducted outside a clinical laboratory, in the proximity of the patient and are often performed by non-laboratory personnel such as nurses, physicians, and patients. POC tests are commonly used where the turnaround time for patient results is short or in areas where central laboratory testing is unavailable [5]. The lack of high-quality diagnostics in resource limited healthcare systems causes significant delays in surveillance, detection, control, and prompt treatment of infectious diseases.…”

Section: Introductionmentioning

confidence: 99%

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REASSURED diagnostics at point-of-care in sub-Saharan Africa: A scoping review

Moetlhoa

Maluleke

Mathebula

et al. 2022

Preprint

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Point-of-care (POC) diagnostics that meet the REASSURED criteria are essential in combating the rapid increase and severity of global health emergencies caused by infectious diseases. However, little is known about whether the REASSURED criteria are implemented in regions known to have a high burden of infectious diseases such as sub-Saharan Africa (SSA). This scoping review maps evidence of the use of REASSURED POC diagnostic tests in SSA. The scoping review was guided by the advanced methodological framework of Arksey and O’Malley, and Levac et al. We searched the following electronic databases for relevant literature: Scopus, Dimensions, ProQuest Central, Google Scholar, and EBSCOhost (MEDLINE, CINAHL, as well as AFRICA-WIDE). Two reviewers independently screened abstracts and full-text articles using the inclusion criteria as reference. We appraised the quality of the included studies using the mixed-method appraisal tool (MMAT) version 2018. We retrieved 138 publications, comprising 134 articles and four grey literature articles. Of these, only five articles were included following abstract and full-text screening. The five included studies were all conducted in SSA. The following themes emerged from the eligible articles: quality assurance on accuracy of REASSURED POC diagnostic tests, sustainability of REASSURED POC diagnostic tests, and local infrastructure capability for delivering REASSURED POC diagnostic tests to end users. All five articles had MMAT scores between 90% and 100%. In conclusion, our scoping review revealed limited published research on REASSURED diagnostics at POC in SSA. We recommend primary studies aimed at investigating the implementation of REASSURED POC diagnostic tests in SSA.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

REASSURED diagnostics at point-of-care in sub-Saharan Africa: A scoping review

Moetlhoa

Maluleke

Mathebula

et al. 2022

Preprint

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“…Residual swab specimens (e.g. fresh or previously frozen), contrived dry swabs, or extraction buffer spiked with a known amount of viral material can be used in verification studies [41] . Samples may be selected based on days post-symptom onset, viral load Ct values from laboratory-based RT-PCR, or viral copy number.…”

Section: Quality Management Framework For Sars-cov-2 Poctmentioning

confidence: 99%

“…fresh or previously frozen) can be used when liquid transport media is acceptable to use with the POCT For NAAT only accepting dry swabs, contrived dry swabs can be created using residual swab specimens in universal transport media (e.g. fresh or previously frozen) following the method described by the FDA [41] or residual specimen transport media can be used to spike the POC extraction buffer NOTE: it is important to choose samples with Ct values that take into account the limit of detection of the POCT and the extra dilution step when adding the dry swab or transport buffer to the extraction buffer Manufacturer QC or third-party, commercial material with known viral load may be used but is suboptimal compared to clinical samples Specimen stability(if testing will not be completed immediately) Many manufacturers recommend to perform analysis within a set time after specimen collection or after adding specimen to the POCT extraction buffer Verify time intervals expected with typical daily workflow and if delays in testing after specimen collection are expected, ensure results with delayed testing are comparable to testing fresh specimens Repeatability Patient samples or QC material SARS-CoV-2 negative, strong positive, and moderate/weak positive (close to claimed positive/negative cut-off or LOD) Run each level once a day/shift for at least 3 days/shifts Preferably by different operators Patient samples or QC material SARS-CoV-2 negative, strong positive, and moderate/weak positive (close to claimed cut-off or LOD) Run each level once a day/shift for at least 3 days/shifts Preferably by different operators When Ct data are available, measure precision aiming for ≤5% CV When more than one gene is targets, measure repeatability/precision for each gene target Limit of detection verification Residual patient samples with moderate Ct Perform a series of dilutions bracketing expected cut-off and LOD For each dilution, run samples in replicates of 5-10 (all data should be Log10 transformed for analysis). Cut-off/LOD: Equivalent to Ct value at which 95% of replicates remain positive.…”

Section: Quality Management Framework For Sars-cov-2 Poctmentioning

confidence: 99%

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Canadian Society of Clinical Chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests

Taher

Randell

Arnoldo

et al. 2021

Clinical Biochemistry

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Objectives A consensus guidance is provided for testing, utility and verification of SARS-CoV-2 point-of-care test (POCT) performance and implementation of a quality management program, focusing on nucleic acid and antigen targeted technologies. Design and Methods The recommendations are based on current literature and expert opinion from the members of Canadian Society of Clinical Chemists (CSCC), and are intended for use inside or outside of healthcare settings that have varied levels of expertise and experience with POCT. Results and Conclusions Here we discuss sampling requirements, biosafety, SARS-CoV-2 point-of-care testing methodologies (with focus on Health Canada approved tests), test performance and limitations, test selection, testing utility, development and implementation of quality management systems, quality improvement, and medical and scientific oversight.

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Advances in Point‐Of‐Care Testing for Emergency Response, Infectious Diseases, and Critical Care — Novel Technologies, Practice Standards, and Improved Outcomes

Füzéry¹,

Kost²,

Tran³

2022

Encyclopedia of Analytical Chemistry

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We present strategies for point‐of‐care testing ( POCT ) that pave the way for diagnostic portals from homes to intensive care. Now well recognized worldwide by the public and professionals alike, POCT has become ubiquitous. Its scope encompasses mobile field rescue, emergency rooms, and hospital intensive care, where rapid test results help stabilize critically ill patients. We introduce novel technologies and insights for effective application of POCT, including identifying infectious pathogens. We chronicle the discovery of the clinical significance of ionized calcium, the ‘fifth electrolyte,’ an obligatory whole‐blood analyte. We tabulate outcomes associated with whole‐blood analysis, which has progressed significantly across the globe. Progressively endemic, coronavirus disease 2019 is catapulting POCT to new heights. This striking expansion calls for more practical know‐how among laboratorians and public health officials, careful planning of POC strategies in healthcare small‐world networks, and support by national guidelines and policies, especially in limited‐resource settings. Technical, clinical, and cultural advances predict exponential growth as the world embraces faster, smaller, and smarter connected diagnostic decision making where it counts the most, at points of need. This POC paradigm shift means learning novel principles and appreciating new standards for POC devices used on ambulances for emergency rescue, so we start there.

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Quality assurance practices for point of care testing programs: Recommendations by the Canadian society of clinical chemists point of care testing interest group

Cited by 21 publications

References 20 publications

REASSURED diagnostics at point-of-care in sub-Saharan Africa: A scoping review

REASSURED diagnostics at point-of-care in sub-Saharan Africa: A scoping review

Canadian Society of Clinical Chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests

Advances in Point‐Of‐Care Testing for Emergency Response, Infectious Diseases, and Critical Care — Novel Technologies, Practice Standards, and Improved Outcomes

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