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Clinical Advances in Specimen Collection and Laboratory Testing in Population Health

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Clinical Laboratory Medicine".

Deadline for manuscript submissions: closed (25 October 2024) | Viewed by 9060

Special Issue Editors

Dr. Jing Cao

E-Mail Website
Guest Editor
Department of Pathology, University of Texas Southwestern Medical Center Dallas, Dallas, TX, USA
Interests: population health; laboratory operation; biomarker
Special Issues, Collections and Topics in MDPI journals
Dr. Xin Yi

E-Mail Website
Guest Editor
1. Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, TX 77030, USA
2. Department of Pathology and Laboratory Medicine, Weill Cornell Medical College, New York, NY 10065, USA
Interests: clinical diagnostics; cancer; laboratory medicine; population health
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Collaboration between population health and clinical diagnostics has been at the forefront of our fight against SARS-CoV-2. Advances in specimen collection and laboratory testing have collectively informed healthcare policy and actions, creating a multitude of future opportunities. There is a need to better understand what the available techniques are, as well as potential diagnostic targets, and how to practice such interventions.

The SARS-COVID 2 pandemic and healthcare outreach to broader populations are shifting diagnostic service from hospital and clinic-based to population-based testing. Novel collection methods such as self-collection are particularly suited to support primary screening and treatment monitoring in vulnerable groups. Testing technologies such as isothermal nucleic acid identification and ultra-sensitive POCT protein quantification have expanded our capacity in diagnostics. This issue provides a timely update on feasibility and accuracy of these approaches, as well as on implementation of workflow, focusing on at-home use of specimen collection devices and analyzers, isothermal technology for nucleic acid identification and quantification, and ultra-sensitive protein quantification on POCT devices.

Overall, this issue aims to educate readers on the methodology of specimen collection and laboratory assays and to present pioneer findings in this field. The scope covers but is not limited to sample types of saliva, nasal swab, blood, and non-invasive body fluid, analytes of hormone, drug, protein, bacterial, and viral antigen and nucleic acid. Review papers, original research, and editorials are invited.

Dr. Jing Cao
Dr. Xin Yi
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Journal of Clinical Medicine is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • self-collection
  • saliva
  • POCT
  • diagnostics
  • infectious disease
  • dry blood spot

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Published Papers (6 papers)

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Research

9 pages, 205 KiB  
Article
Preanalytical Considerations of Handling Suspected Creutzfeldt–Jakob Disease Specimens Within the Clinical Pathology Laboratories: A Survey-Based Approach
by Carla Stephan, Taylor Kalomeris, Yaxin Li, Jeffrey Kubiak, Sabrina Racine-Brzostek, Ivo SahBandar, Zhen Zhao, Melissa M. Cushing and He S. Yang
J. Clin. Med. 2025, 14(1), 204; https://doi.org/10.3390/jcm14010204 - 2 Jan 2025
Viewed by 793
Abstract
Background: Creutzfeldt–Jakob disease (CJD) is a rare, fatal, and transmissible neurodegenerative disorder caused by prion proteins. Handling specimens from individuals with suspected or confirmed cases presents a safety challenge to hospital workers including clinical laboratory staff. As no national guidelines exist, the clinical [...] Read more.
Background: Creutzfeldt–Jakob disease (CJD) is a rare, fatal, and transmissible neurodegenerative disorder caused by prion proteins. Handling specimens from individuals with suspected or confirmed cases presents a safety challenge to hospital workers including clinical laboratory staff. As no national guidelines exist, the clinical pathology laboratory must establish protocols for handling these specimens to ensure sufficient protective measures. This study aims to explore how various medical institutions manage CJD specimens, as a first step toward developing standardized preanalytical protocols for safe specimen handling by health care professionals. Methods: An electronic survey was generated and disseminated to diplomats of the American Board of Clinical Chemistry and was posted on the Listserv platform of the American Society for Microbiology and the Artery forum of the Association for Diagnostics and Laboratory Medicine. The survey evaluated various procedures and precautions implemented, the nature of the specimens processed, and whether they are processed in-house or sent to reference laboratories. Results: A total of 49 responses were collected. Most respondents (64%) noted their laboratories process specimens with a clinical suspicion of CJD regardless of the level of suspicion, 13% handled specimens only if the degree of suspicion was low, and 16% did not process specimens in-house at all. Among those who process CJD specimens, practices varied greatly, including different levels of precautions, use of biological safety cabinets, aliquoting, disposal, and disinfection procedures. Conclusions: A lack of standardization across laboratories exists for the handling of specimens of patients with suspected CJD. This study summarizes the approaches reported by survey respondents, providing a rationale for developing protocols for the safe handling of these specimens and highlighting the need to develop uniform universal standardized processing procedures. Full article
(This article belongs to the Special Issue Clinical Advances in Specimen Collection and Laboratory Testing in Population Health)
11 pages, 1619 KiB  
Article
Method Evaluation of the QuidelOrtho Diagnostics Vitros NT-proBNP II Assay
by Yi Xiao, Chao Sun, Justin Tsan and Edward Ki Yun Leung
J. Clin. Med. 2024, 13(24), 7751; https://doi.org/10.3390/jcm13247751 - 19 Dec 2024
Viewed by 753
Abstract
Background/Objectives: N-terminal-proBNP (NT-proBNP) is a biomarker released into the blood in response to heart failure, reflecting the extent of cardiac stress and damage. QuidelOrtho Diagnostics released its latest reformulation of its NT-proBNP assay, the Vitros NT-proBNP II assay. This study aims to evaluate [...] Read more.
Background/Objectives: N-terminal-proBNP (NT-proBNP) is a biomarker released into the blood in response to heart failure, reflecting the extent of cardiac stress and damage. QuidelOrtho Diagnostics released its latest reformulation of its NT-proBNP assay, the Vitros NT-proBNP II assay. This study aims to evaluate the analytical performance of the Vitros NT-proBNP II assay. Methods: Repeatability, reproducibility, carryover, analytical measurement range, and clinical reportable range (AMR and CRR) were assessed using commercially available materials and dilution of patient specimens. Accuracy was evaluated by comparing results from the Vitros NT-proBNP II and the Vitros NT-proBNP assays. Paired heparin and EDTA plasma specimen results were compared, and instrument-to-instrument comparison was performed using two different Vitros 5600 Integrated Systems. NT-proBNP stability was evaluated at room temperature, 2–8 °C, and −18 °C for up to five days. Results: Repeatability and reproducibility were ≤10% CV, and no carryover was observed. The AMR was 20–30,000 pg/mL and dilution up to 80 times was verified. Passing–Bablok analysis showed a significant proportional bias with a slope of 1.37. Instrument-to-instrument and heparin-to-EDTA plasma comparisons showed no significant biases. NT-proBNP is stable up to five days at room temperature, 4 °C, and −20 °C. Conclusions: Our evaluation demonstrated acceptable analytical performances of the Vitros NT-proBNP II assay except for the positive proportional bias compared with the Vitros NT-proBNP assay. Full article
(This article belongs to the Special Issue Clinical Advances in Specimen Collection and Laboratory Testing in Population Health)
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9 pages, 1094 KiB  
Article
Sensitive LC-MS/MS Assay for Total Testosterone Quantification on Unit Resolution and High-Resolution Instruments
by Jill K. Wolken, Meghan M. Peterson, Wenjing Cao, Keith Challoner and Zhicheng Jin
J. Clin. Med. 2024, 13(23), 7056; https://doi.org/10.3390/jcm13237056 - 22 Nov 2024
Viewed by 1212
Abstract
Background: Testosterone is an androgenic hormone that plays important roles in both males and females. The circulating levels of total testosterone vary from 1 to 1480 ng/dL. High-throughput immunoassays often lack accuracy in lower concentration ranges (below 100 ng/dL), particularly when used [...] Read more.
Background: Testosterone is an androgenic hormone that plays important roles in both males and females. The circulating levels of total testosterone vary from 1 to 1480 ng/dL. High-throughput immunoassays often lack accuracy in lower concentration ranges (below 100 ng/dL), particularly when used for females or children. To address this limitation, we developed a total testosterone LC-MS/MS assay on three instruments. Methods: Sample preparation began with the dilution and conditioning of 200 µL of serum. A supported liquid extraction cartridge was used to extract the analyte from biological matrices. Chromatographic separation was achieved using a C18 column with a runtime of 5 min per sample. This assay was validated on a Triple Quad 6500 and an API 4500 instrument. Results: Method validation was carried out according to the CLSI C62-ED2 guideline and our hospital protocol. The within-day coefficient of variation (CV) was less than 10% and the between-day CV was less than 15%. The assay had a limit of quantitation of 0.5 ng/dL with an analyte measure range of 2–1200 ng/dL. A comparison using Deming regression and Bland–Altman plots showed that this assay correlated well with a reference method. The results from the API 4500 and an Orbitrap were consistent with those from the TQ 6500. Both serum-separator tubes (BD) and serum-activator tubes were found to be suitable. Conclusions: We successfully developed and validated a robust total testosterone LC-MS/MS assay for routine clinical testing. This assay was harmonized across two triple quadrupole instruments and one high-resolution mass spectrometer. Full article
(This article belongs to the Special Issue Clinical Advances in Specimen Collection and Laboratory Testing in Population Health)
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16 pages, 12097 KiB  
Article
BD Vacutainer™ Urine Culture & Sensitivity Preservative PLUS Plastic Tubes Minimize the Harmful Impact of Stressors Dependent on Temperature and Time Storage in Uropathogenic Bacteria
by Samuel Treviño, Eduardo Ramírez-Flores, Steffany Cortezano-Esteban, Hugo Hernández-Fragoso and Eduardo Brambila
J. Clin. Med. 2024, 13(17), 5334; https://doi.org/10.3390/jcm13175334 - 9 Sep 2024
Viewed by 1369
Abstract
Background: Urinary tract infection is a worldwide health problem. According to the Clinical Laboratory Improvement Amendments and the European Urinalysis Guideline, urine samples should be tested within 2 h of collection. Thus, using chemical preservatives that guarantee the pre-analytical conditions is a practical [...] Read more.
Background: Urinary tract infection is a worldwide health problem. According to the Clinical Laboratory Improvement Amendments and the European Urinalysis Guideline, urine samples should be tested within 2 h of collection. Thus, using chemical preservatives that guarantee the pre-analytical conditions is a practical tool. However, the effects of temperature and storage time as uropathogenic bacteria stressors are unclear. Methods: Gram-negative and -positive ATTC strains, E. coli, P. mirabilis, E. faecalis, and S. aureus, were used in this study. Strains in liquid media were stored at 4, 25, and 37 °C for 0, 2, 12, 24, and 48 h in tubes with and without preservatives. Then, reactive oxygen species (ROS) levels, viable but non-culturable bacteria (VBNC), and bacteria growth were analyzed. Results: A high ROS level was associated with the presence of VBNC and dead bacteria with low CFU counts, but a low ROS level increased the CFU number, depending on temperature and storage time in tubes without preservatives (boric acid, sodium borate, and formate). The BD Vacutainer™ Urine Culture & Sensitivity Preservative PLUS Plastic Tubes (C&S-PP) prevent this ROS increase, maintaining the CFU number for longer. Conclusions: C&S-PP tubes minimize the stressor effects (temperature and time storage) on uropathogenic bacteria when stored, improving the pre-analytical conditions of cultures realized by the clinical laboratory. Full article
(This article belongs to the Special Issue Clinical Advances in Specimen Collection and Laboratory Testing in Population Health)
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11 pages, 1170 KiB  
Article
Accuracy-Based Glomerular Filtration Rate Assessment by Plasma Iohexol Clearance in Kidney Transplant Donors
by Zhicheng Jin, Rongrong Huang, Paul Christensen, Roger L. Bertholf and Xin Yi
J. Clin. Med. 2023, 12(18), 6054; https://doi.org/10.3390/jcm12186054 - 19 Sep 2023
Cited by 1 | Viewed by 1525
Abstract
Background: An accurate measurement of the glomerular filtration rate (GFR) is essential for detecting renal insufficiency in living kidney donors. Iohexol is a “near-ideal” exogenous filtration marker for GFR measurements that has attracted increasing interest in clinical practice because it is non-toxic, non-radioactive, [...] Read more.
Background: An accurate measurement of the glomerular filtration rate (GFR) is essential for detecting renal insufficiency in living kidney donors. Iohexol is a “near-ideal” exogenous filtration marker for GFR measurements that has attracted increasing interest in clinical practice because it is non-toxic, non-radioactive, readily available, and easy to measure. In this study, we aimed to set up a laboratory test to conveniently assess the plasma clearance of iohexol in living kidney donors. Methods: A workflow was established in the institution’s infusion clinic to administer iohexol and to collect three timed blood samples from renal transplant donors. Iohexol was thereafter measured by liquid chromatography–tandem mass spectrometry (LC-MS/MS). The serum proteins were precipitated and the supernatant containing iohexol was diluted prior to the LC-MS/MS analysis. The LC-MS/MS method was developed on a Thermo Vanquish UHPLC coupled with a TSQ Endura triple quadruple mass spectrometer with a total run time of 2.5 min. The analytical performance of the method was assessed. Results: The LC-MS/MS method demonstrated a good analytical performance. To calculate the iohexol clearance rate and the GFR, automated data integration and a result calculation were accomplished by using a custom Python script. Automated result reporting was achieved using a laboratory informatics system (LIS) vendor’s direct media interface. Conclusions: We developed and implemented a laboratory test to assess the plasma clearance of iohexol. A workflow was established in the hospital to reliably measure the GFR in living kidney donors, with a potential to be further expanded into other areas where an accurate GFR measurement is needed. Full article
(This article belongs to the Special Issue Clinical Advances in Specimen Collection and Laboratory Testing in Population Health)
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11 pages, 3284 KiB  
Article
Evaluation of the Accuracy of Cr and BUN Using the ABL90 FLEX PLUS Blood Gas Analyzer and the Equivalence of Candidate Specimens for Assessment of Renal Function
by Ha-Jin Lim, Seung-Yeob Lee and Hyun-Jung Choi
J. Clin. Med. 2023, 12(5), 1940; https://doi.org/10.3390/jcm12051940 - 1 Mar 2023
Cited by 1 | Viewed by 2497
Abstract
Background: The ABL90 FLEX PLUS (Radiometer) is a blood gas analyzer that also provides creatinine (Cr) and blood urea nitrogen (BUN) results. We assessed the accuracy of the ABL90 FLEX PLUS to measure Cr and BUN and find suitable candidate specimens against primary [...] Read more.
Background: The ABL90 FLEX PLUS (Radiometer) is a blood gas analyzer that also provides creatinine (Cr) and blood urea nitrogen (BUN) results. We assessed the accuracy of the ABL90 FLEX PLUS to measure Cr and BUN and find suitable candidate specimens against primary specimens (heparinized whole-blood (H-WB)). Methods: Paired H-WB, serum, and sodium-citrated whole-blood (C-WB) samples (105) were collected. The Cr and BUN levels in the H-WB using the ABL90 FLEX PLUS were compared with those of the serum using four automated chemistry analyzers. The suitability of the candidate specimens was assessed at each medical decision level according to the CLSI guideline EP35-ED1. Results: The respective mean differences of the ABL90 FLEX PLUS for the Cr and BUN were below −0.10 and −3.51 mg/dL compared to the other analyzers. The systematic differences between the serum and the H-WB at the low, medium, and high medical decision levels were all 0% for Cr, but those of the C-WB were −12.96%, −11.81%, and −11.30%, respectively. Regarding imprecision, the SDserum/SDH-WB ratios at each level were 0.14, 1.41, and 0.68, whereas the SDC-WB/SDH-WB ratios were 0.35, 2.00, and 0.73, respectively. Conclusions: The ABL90 FLEX PLUS provided Cr and BUN results comparable with the four widely used analyzers. Among the candidates, the serum was suitable for Cr testing using the ABL90 FLEX PLUS, while the C-WB did not satisfy the acceptance criteria. Full article
(This article belongs to the Special Issue Clinical Advances in Specimen Collection and Laboratory Testing in Population Health)
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