EXPRESS: Reducing neonatal phlebotomy blood losses through the accurate calculation of minimum test volume requirements

2021 ◽  
pp. 000456322110309
Author(s):  
Eric Stephen Kilpatrick ◽  
Elicia Ginn ◽  
Ben Lee
Keyword(s):  
Diagnostic Testing ◽  
Clinical Decision ◽  
Neonatal Unit ◽  
Accurate Calculation ◽  
Serum Samples ◽  
Test Volume ◽  
Blood Tests ◽  
Critically Ill Neonates ◽  
Minimum Volumes ◽  
Test Profiles

Background: Repeated phlebotomy for laboratory diagnostic testing is a known cause of iatrogenic anaemia and in critically ill neonates often leads to blood transfusion being required. This study has developed a spreadsheet clinical decision support (CDS) tool to allow neonatal staff to determine the true minimum blood volume (MBV) required to analyse groups of blood tests and modelled its potential benefit compared to the existing system in use. Methods: The tool calculates the MBV accounting for novel factors including the current patient haematocrit for plasma/serum samples, instrument minimum test and dead volumes (including those where shared) and sharing of samples within/between laboratory departments. A year of neonatal unit laboratory requests were examined comparing the volumes and containers of blood recommended by the hospital information system (HIS) with both the amount actually collected by staff and that recommended by the tool. Results: 463 patients had 8,481 blood draws for 23,899 tests or test profiles over the year. The HIS recommended collecting 11,222mL of blood into 18,509 containers, while 17,734 containers were actually received (10,717mL if fully filled). The tool recommended collecting 4,915mL of blood into 15,549 containers. Conclusions: This tool allows NICU staff to objectively determine the MBV required for a combination of tests and is generalisable between laboratory instruments. Compared to the HIS, use of the MBV-CDS tool could maximally reduce the volume of blood collected from this neonatal unit by more than a half. NICU staff had apparently already gone some way to determining their own minimum volumes required.

scholarly journals Geographic and demographic heterogeneity of SARS-CoV-2 diagnostic testing in Illinois, USA, March to December 2020

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tobias M. Holden ◽  
Reese A. K. Richardson ◽  
Philip Arevalo ◽  
Wayne A. Duffus ◽  
Manuela Runge ◽  
...  
Keyword(s):  
Diagnostic Testing ◽  
Case Fatality ◽  
The United States ◽  
Test Volume ◽  
Demographic Groups ◽  
Demographic Heterogeneity ◽  
Large Expansion ◽  
Matched Case ◽  
Geographic Regions ◽  
Hispanic White

Abstract Background Availability of SARS-CoV-2 testing in the United States (U.S.) has fluctuated through the course of the COVID-19 pandemic, including in the U.S. state of Illinois. Despite substantial ramp-up in test volume, access to SARS-CoV-2 testing remains limited, heterogeneous, and insufficient to control spread. Methods We compared SARS-CoV-2 testing rates across geographic regions, over time, and by demographic characteristics (i.e., age and racial/ethnic groups) in Illinois during March through December 2020. We compared age-matched case fatality ratios and infection fatality ratios through time to estimate the fraction of SARS-CoV-2 infections that have been detected through diagnostic testing. Results By the end of 2020, initial geographic differences in testing rates had closed substantially. Case fatality ratios were higher in non-Hispanic Black and Hispanic/Latino populations in Illinois relative to non-Hispanic White populations, suggesting that tests were insufficient to accurately capture the true burden of COVID-19 disease in the minority populations during the initial epidemic wave. While testing disparities decreased during 2020, Hispanic/Latino populations consistently remained the least tested at 1.87 tests per 1000 population per day compared with 2.58 and 2.87 for non-Hispanic Black and non-Hispanic White populations, respectively, at the end of 2020. Despite a large expansion in testing since the beginning of the first wave of the epidemic, we estimated that over half (50–80%) of all SARS-CoV-2 infections were not detected by diagnostic testing and continued to evade surveillance. Conclusions Systematic methods for identifying relatively under-tested geographic regions and demographic groups may enable policymakers to regularly monitor and evaluate the shifting landscape of diagnostic testing, allowing officials to prioritize allocation of testing resources to reduce disparities in COVID-19 burden and eventually reduce SARS-CoV-2 transmission.

Pediatric reference interval verification for endocrine and fertility hormone assays on the Abbott Alinity system

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mary Kathryn Bohn ◽  
Siobhan Wilson ◽  
Alexandra Hall ◽  
Khosrow Adeli
Keyword(s):  
Clinical Decision Making ◽  
De Novo ◽  
Reference Interval ◽  
Clinical Decision ◽  
Reference Intervals ◽  
Healthy Children ◽  
Confidence Limits ◽  
Test Results ◽  
Serum Samples ◽  
Abbott Architect

Abstract Objectives The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has developed an extensive database of reference intervals (RIs) for several biomarkers on various analytical systems. In this study, pediatric RIs were verified for key immunoassays on the Abbott Alinity system based on the analysis of healthy children samples and comparison to comprehensive RIs previously established for Abbott ARCHITECT assays. Methods Analytical performance of Alinity immunoassays was first assessed. Subsequently, 100 serum samples from healthy children recruited with informed consent were analyzed for 16 Alinity immunoassays. The percentage of test results falling within published CALIPER ARCHITECT reference and confidence limits was determined. If ≥ 90% of test results fell within the confidence limits, they were considered verified based on CLSI guidelines. If <90% of test results fell within the confidence limits, additional samples were analyzed and new Alinity RIs were established. Results Of the 16 immunoassays assessed, 13 met the criteria for verification with test results from ≥ 90% of healthy serum samples falling within the published ARCHITECT confidence limits. New CALIPER RIs were established for free thyroxine and prolactin on the Alinity system. Estradiol required special considerations in early life. Conclusions Our data demonstrate excellent concordance between ARCHITECT and Alinity immunoassays, as well as the robustness of previously established CALIPER RIs for most immunoassays, eliminating the need for de novo RI studies for most parameters. Availability of pediatric RIs for immunoassays on the Alinity system will assist clinical laboratories using this new platform and contribute to improved clinical decision-making.

scholarly journals Point-of-Care Testing-the Key in the Battle against SARS-CoV-2 Pandemic

Micromachines ◽  
2021 ◽  
Vol 12 (12) ◽  
pp. 1464
Author(s):  
Florina Silvia Iliescu ◽  
Ana Maria Ionescu ◽  
Larisa Gogianu ◽  
Monica Simion ◽  
Violeta Dediu ◽  
...  
Keyword(s):  
Clinical Decision Making ◽  
Point Of Care ◽  
Low Cost ◽  
Diagnostic Testing ◽  
Clinical Decision ◽  
Rapid Screening ◽  
Diagnostic Tools ◽  
Point Of Care Testing ◽  
Qrt Pcr ◽  
User Friendly

The deleterious effects of the coronavirus disease 2019 (COVID-19) pandemic urged the development of diagnostic tools to manage the spread of disease. Currently, the “gold standard” involves the use of quantitative real-time polymerase chain reaction (qRT-PCR) for SARS-CoV-2 detection. Even though it is sensitive, specific and applicable for large batches of samples, qRT-PCR is labour-intensive, time-consuming, requires trained personnel and is not available in remote settings. This review summarizes and compares the available strategies for COVID-19: serological testing, Point-of-Care Testing, nanotechnology-based approaches and biosensors. Last but not least, we address the advantages and limitations of these methods as well as perspectives in COVID-19 diagnostics. The effort is constantly focused on understanding the quickly changing landscape of available diagnostic testing of COVID-19 at the clinical levels and introducing reliable and rapid screening point of care testing. The last approach is key to aid the clinical decision-making process for infection control, enhancing an appropriate treatment strategy and prompt isolation of asymptomatic/mild cases. As a viable alternative, Point-of-Care Testing (POCT) is typically low-cost and user-friendly, hence harbouring tremendous potential for rapid COVID-19 diagnosis.

Significant decline in cancer diagnostic testing in U.S. CMS population during the COVID-19 pandemic.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6536-6536
Author(s):  
Dave Smart ◽  
Peter Riccelli ◽  
Keith Kerr ◽  
Jordan Clark ◽  
Susanne Munksted Fosvig ◽  
...  
Keyword(s):  
Primary Care ◽  
Cancer Diagnosis ◽  
Primary Care Physicians ◽  
Diagnostic Testing ◽  
Delayed Diagnosis ◽  
Cancer Control ◽  
Unintended Consequences ◽  
Initial Diagnosis ◽  
Test Volume ◽  
The Us

6536 Background: The COVID-19 pandemic has caused >400,000 infection related deaths in the US to January 2021. Actions taken to limit COVID-19 infection and mortality could potentially lead to unintended consequences, precipitating excess mortality due to other causes. One such cause is delayed cancer diagnosis. Significant decreases in presentation for cancer diagnosis at the primary care level have been noted in the UK. This study aimed to look for evidence of a similar effect in the US. Methods: CMS claims data from JAN18-JUN20 associated with primary diagnosis across 11 cancers (bladder, breast, cervical, colorectal, endometrial, lung, ovarian, pancreatic, prostate, sarcoma and thyroid) were analyzed for use of surgical pathology (SP), a procedure associated with initial diagnosis, and immunohistochemistry (IHC). Test volumes varied widely by test and cancer so were normalized to enable comparison across indications. This was done by dividing the month-on-month difference for the period JAN19-JUN19 vs JAN20-JUN20 by the median monthly test volume for the period JAN18-DEC19 (“pre-COVID period”). Extent and duration of declines in test rates and number of missing patients as the sum of these declines were then determined. The ratio of IHC to SP testing was taken to determine any decline in likely post-initial diagnosis testing. Results: There were significant (>10%) declines in test volumes for SP for all 11 cancers at some time in Q1-Q2 2020. Table. Extent, duration and return to pre-COVID levels for SP testing across 11 cancers Median extent and duration of the decline was 56% (range 41.1%-80.4%) and 2 months (range 1- >4). This equates to 32,192 missing diagnoses across all cancers. SP test volumes for all cancers except lung and breast had returned to around pre-COVID levels by JUN20. There was no significant (>10%) increase in normalized SP test volume after the COVID dip for any cancer. While SP showed decreased test volumes across all cancers at some point during the first half of 2020, test volume ratios of IHC to SP showed increases for most cancers in the same time period. Conclusions: These data highlight that the decline in patients presenting to their primary care physicians with suspicion of cancer for diagnostic investigation was linked to COVID-19 prevention strategies. No evidence for increased, “catch up” testing to address presentational/diagnostic backlog was observed. Thus, it is predicted that these patients may subsequently present with a more advanced cancer. Potential excess morbidity, mortality and cost associated with absent or delayed diagnosis should be factored into cancer control programs going forward.[Table: see text]

THE VALUE OF IN VITRO DIAGNOSTIC TESTING IN THE PROVISION OF MEDICAL CARE TO ELDERLY PATIENTS WITH CARDIOVASCULAR DISEASES

2020 ◽  
Vol 65 (3) ◽  
pp. 191-196
Author(s):  
A. S. Pushkin ◽  
O. V. Lyang ◽  
T. A. Ahmedov ◽  
S. A. Rukavishnikova
Keyword(s):  
Decision Making ◽  
Medical Care ◽  
Laboratory Tests ◽  
Clinical Decision Making ◽  
Diagnostic Testing ◽  
Clinical Decision ◽  
Initial Examination ◽  
Attending Physicians ◽  
The Impact

In vitro diagnostics are used at all stages of patient care. The aim of this study was to assess the impact of laboratory examination on clinical decision-making in providing medical care to patients with a cardiovascular profile. We also took into account the level of financing for the laboratory industry in the Russian Federation. We divided our study on three sequential steps: literature review, survey of clinicians and test-survey of clinicians. The share of costs for the laboratory tests in 2017 amounted to about 8% of the total funding for Russian health care. About 80% (70; 90) of the visits of the attending physicians are associated with the appointment of laboratory tests. Among patients who were prescribed any laboratory test - in 62.1% (95% CI 16.9-24.9) cases, the results of these tests influenced clinical decision making related to the initiation, modification or termination of any treatment. All visits of clinicians were divided by purpose: tests were prescribed in almost 100% (90; 100) cases during the initial examination, in 40% (20; 60) cases during repeated visits, and in 40% (15; 40) cases when patients were examined before discharge. In more than half of cases (57,4%; n=31), doctors correctly assumed about the about the share of financing of the laboratory industry. The majority of respondents considered the amount of expenses adequate and recommended to maintain the current level in the future. According to attending physicians, new laboratory markers should demonstrate additional information about clinical relevance to improve patient outcomes. Thus, in current economic realities, future laboratory tests should be financially maximally available and at the same time be clinically highly effective auxiliary instruments. It creates new challenges in finding laboratory biomarkers and putting them into clinical practice.

scholarly journals Detection of SARS-CoV-2-specific antibodies via rapid diagnostic immunoassays in COVID-19 patients

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Jira Chansaenroj ◽  
Ritthideach Yorsaeng ◽  
Nawarat Posuwan ◽  
Jiratchaya Puenpa ◽  
Natthinee Sudhinaraset ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Diagnostic Testing ◽  
Cross Reactivity ◽  
Molecular Diagnostic ◽  
Monitoring And Control ◽  
Serum Samples ◽  
Cross Sectional ◽  
Seropositivity Rate ◽  
Asymptomatic Patients ◽  
And Control

Abstract Background Efficient monitoring and control of coronavirus disease 2019 (COVID-19) require access to diagnostic tests, and serological diagnostic testing is desirable. In the current study, antibodies were investigated in patients recently diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Methods Cross-sectional data were obtained from 245 patients in whom SARS-CoV-2 infection had been confirmed via real-time reverse transcriptase-polymerase chain reaction between March and October 2020. Serum samples were acquired between 2 and 60 days following the onset of COVID-19 symptoms or the first detection of SARS-CoV-2 in asymptomatic patients. All specimens were tested simultaneously using an IgM/IgG rapid diagnostic test (RDT), IgG nucleocapsid protein-based chemiluminescent microparticle immunoassay (CMIA), IgG, and IgA spike protein-based enzyme-linked immunosorbent assays (ELISAs). Blood donor samples obtained in 2018 were used as negative controls. Results The sensitivity and specificity of the RDT IgG were compared with the IgG immunoassays as standards. The RDT IgG exhibited 97.5% sensitivity and 89.4% specificity compared with a CMIA IgG, 98.4% sensitivity, and 78.8% specificity compared with an ELISA IgG. IgM, IgG, and IgA seropositivity rates were low between 1 and 2 weeks after COVID-19 symptom onset or the detection of SARS-CoV-2 RNA. IgM seropositivity rate began decreasing after 4 weeks, whereas IgG and IgA seropositivity rate remained at appreciable levels over the 8-week study period. No cross-reactivity with seasonal coronaviruses was detected. Conclusions IgG RDT alone or combined with molecular diagnostic tests may be useful for identifying recent SARS-CoV-2 infection.

scholarly journals Genomic screening and genomic diagnostic testing—two very different kettles of fish

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Leslie G. Biesecker
Keyword(s):  
Decision Making ◽  
Clinical Decision Making ◽  
Diagnostic Testing ◽  
Clinical Decision ◽  
Bayes Theorem ◽  
Genomic Testing ◽  
Test Results ◽  
Correct Interpretation ◽  
Genomic Test ◽  
Genomic Screening

AbstractGenomic testing can be misunderstood as being determinative, when in reality it is the same as all other tests and context is essential for its correct interpretation. Two hypothetical cases of testing for Marfan syndrome demonstrate how clinicians should contextualize genomic test results and the implementation of Bayes theorem in clinical decision-making.

A 52-Year-Old Man With Progressive Weakness and Incontinence

2021 ◽  
pp. 194187442110395
Author(s):  
Ayse Altintas ◽  
Ayca Ersen Danyeli ◽  
Subutay Berke Bozkurt ◽  
Sanem Pinar Uysal ◽  
Sergin Akpek ◽  
...  
Keyword(s):  
Decision Making ◽  
Urinary Retention ◽  
Clinical Decision Making ◽  
Treatment Options ◽  
Diagnostic Testing ◽  
Clinical Decision ◽  
Diagnostic Tools ◽  
Progressive Weakness ◽  
Over Time

Here we report a challenging case of a 52-year-old man presenting with subacute constipation, urinary retention, impotence, absent Achilles reflexes, and hypoesthesia in S2-S5 dermatomes. We review the clinical decision-making as the symptoms evolved and diagnostic testing changed over time. Once the diagnosis is settled, we discuss the sign and symptoms, additional diagnostic tools, treatment options and prognosis.

Affective Aspects of Clinical Reasoning: Their Importance in Assessment of Behavioral Diagnoses in Medical Patients

1984 ◽  
Vol 55 (1) ◽  
pp. 143-149 ◽  
Author(s):  
Donna B. Greenberg ◽  
Sherman Eisenthal ◽  
John D. Stoeckle
Keyword(s):  
Clinical Reasoning ◽  
Clinical Decision Making ◽  
Diagnostic Testing ◽  
Clinical Decision ◽  
Severe Illness ◽  
Probabilistic Logic ◽  
Junior Resident ◽  
Medical Patients ◽  
Office Visits ◽  
Medical Problems

Physicians' expectations of patients' behavior are de facto aspects of clinical reasoning. Yet, for the most part, these aspects are not included in the modern paradigm of clinical decision making, which presumes that physicians should decide only on a normative probabilistic logic. If diagnostic cues are equivocal, physicians are more likely to be affected by the doctor-patient encounter from which they derive their expectations about patients' compliance. Affective aspects of clinical reasoning are particularly important in evaluation of behavioral diagnoses which are often equivocal. Physicians' reasoning about patients' compliance with diagnostic testing and medical treatment was studied by questionnaires completed at the end of the office visits. The physicians' expectations of testing compliance were associated with a high percent of significant medical problems, more severe illness, younger patients, and junior resident staff. The expectation of non-compliance with treatment was associated with a lower percent of significant medical problems, discomfort in talking to the patient, and a behavioral diagnosis. Physicians were more comfortable talking to sicker patients who had significant medical problems. We conclude that physicians expect patients to behave pragmatically, complying with testing and treatment if their problems are serious and treatable. When physicians are uncomfortable with patients because the patients have problems which are deemed less medically significant, more equivocal, or because of the patients' personalities, physicians are more likely to expect that the patient will not take treatment.

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