Research article: Assessment of the Analytical Performance of 14 Analytes using the Epoc® Blood Analysis System

 

Jakoba Sevdal Danielsen, Charlotte Topsøe Voigt, Hanne Koefod, Katja Kemp Jacobsen

 

Abstract
Objective: To evaluate the analytical performance of Epoc® Blood Analysis System for 14 analytes (pH, pCO2, pO2, HCO3-, BE, sO2, Na+, K+, iCa2+, Cl-, Glu, Lac, Crea and BUN)
Material and Methods: The coefficient of variation (CV%) was calculated based on a between-day replication study using internal quality control material at two concentrations. The relative mean difference (BIAS%) was calculated based on method comparisons of 53 to 55 arterial patient samples using ABL 835 Flex Blood Gas Analyzer (Radiometer) and Dimension Vista 1500 System (Siemens Healthineers). The total analytical error (TAE%) was estimated by calculation of the 95% confidence interval, which incorporates the observed CV% from the replication study and BIAS% from the method comparison study. Each analyte’s precision, trueness and accuracy were assessed by comparing the observed CV%, BIAS% and TAE% to the analytical performance specifications (APS) from Westgard for imprecision (I%), bias (B%) and total allowable error (TE%), respectively. The analytical performance using the Epoc were considered acceptable in clinical settings if at least the minimum specifications for accuracy were achieved.
Results: pH, BE, K+, Glu, Lac and BUN fulfilled the minimum specifications for precision, while pCO2, HCO3-, Na+, iCa2+, Cl- and Crea did not. pH, pCO2, Na+, K+, Glu, Lac and BUN fulfilled the minimum specifications for trueness, while HCO3-, iCa2+, Cl- and Crea did not. pH, pCO2, BE, K+, Glu, Lac and BUN fulfilled minimum specifications for accuracy, while iCa2+ did not. No specifications were specified for pO2 and sO2.
Conclusions: pH, pCO2, BE, K+, Glu, Lac and BUN showed analytical performances considered acceptable for use in clinical settings, since at least the minimum specifications regarding accuracy were achieved. iCa2+ showed unacceptable analytical performance for use in clinical settings, whereas the results for HCO3-, Na+, Cl- and Crea were inconclusive.

 

Key words: Point-of-care testing, POCT, Epoc, Method comparison, Biological variation

 

Int. J. Bio. Lab. Sci 2022(11)2:104-113 【PDF】

Research article: Whole Blood Viscosity: Affordances and Re-evaluation of Sensitivity and Specificity for Clinical Use

 

Ezekiel U. Nwose, Phillip T. Bwititi

 

Abstract
Over the years, whole blood viscosity (WBV), an indicator of thickness and stickiness of blood has been a laboratory marker for blood stasis, and useful for monitoring several disorders including cardiovascular diseases (CVD). However, the use of WBV in clinical practice is still limited by affordances, knowledge and attitude. With the development of extrapolated whole blood viscosity (eWBV) method from haematocrit and total serum protein level, what is yet to be established is the sensitivity and specificity of eWBV to address the limitations in clinical practice. The objective of this study was to highlight the discourse on sensitivity, specificity and affordances (accessibility and affordability) of eWBV to re-evaluate the utilization of WBV in clinical practice, especially in low-mid income communities. This was a observational study that used archived data from haematology and biochemistry routine laboratory tests associated with cardiovascular phenomena. Statistical analysis adopted the conventional paired-contingency table method for sensitivities and specificities to assess validity of eWBV in CVD. Reliability was affirmed by consistent significant differences in WBV levels between thrombocytopenia and thrombocytosis (p < 0.005). Calculated validities show that eWBV is ≥64% specific and ≤38% sensitive to cardiovascular phenomena. In conclusion, eWBV is generally less sensitive but more specific for CVD. One major significant finding from this study is that in patients with haematocrit and serum protein results, the risk of bleeding and monitor the effects of therapy can be assessed using specific and accessible eWBV at no extra cost in laboratory service. Being accessible at no extra cost translates to widespread affordance for this laboratory test.

 

Key words: Aspirin, blood stasis, cardiovascular phenomena, clinical practice, laboratory medicine, therapeutic monitoring

 

Int. J. Bio. Lab. Sci 2022(11)2:96-103 【PDF】

Review article: CAR-T Immunotherapy Limitations and Advancements for Relapse and Refractory Pediatric B-Cell Malignancies

 

Diana Woller, Brenda Barnes, Joel E. Mortensen

 

Abstract
Chimeric antigen receptors (CARs) are genetically engineered, T-lymphocyte receptors that target hematological cancer cells and solid tumors. CAR-T cell immunotherapies for B-Cell malignancies target CD19 positive cells and have shown dramatic results in treating pediatric patients since becoming licensed as tisa¬genlecleucel by the US Food and Drug Administration in 2018. Tisagenlecleucel is used to treat relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) and large diffuse B-cell lymphomas (DLBCL) in children and young adults up to age 25. While CAR-T immunotherapies have shown continued promise, crucial limitations are being investigated to improve anti-CD19 CAR-T toxicity, off-target events, bridging and dual treatment requirements, and manufacturing capabilities. This review examines the current limitations and advancements of anti-CD19 CAR-T immunotherapy for pediatric B-cell malignancies focusing on relevant improve¬ment strategies for engineering, efficacy, and patient safety.

 

Key words: Anti-CD19 CAR-T cells; pediatric acute lymphoblastic leukemia; pediatric diffuse large B-cell lymphoma; replapsed/refractory B-cell malignancies; limitations of Anti-CD19CAR-T cell therapy; anti-CD19 CAR-T manufacturing advancements; cytokine release syndrome; neurotoxicity; immunotherapy

 

Int. J. Bio. Lab. Sci 2022(11)2:80-89 【PDF】

Review article: Human Blood Cell Pathophysiology Associated with Acute COVID-19 Infection

 

Anna Nguon, Indu Singh, Roselyn Rose’Meyer

 

Abstract
December 2019 marked the beginning of an outbreak of coronavirus disease (COVID-19 or SARS-CoV-2), which occurred in Wuhan City, Hubei Province, China. The most publicized effect of this virus is its impact on the human lungs, damaging the walls and lining of the air sacs causing respiratory symptoms, such as difficulty breathing and chest pain. This literature review highlights the changes in erythrocytes, leukocytes, and platelets during COVID-19 infections. Publicly available articles and reports related to COVID-19 infections on blood cell populations were collected and summarized. COVID-19 viral infections alter erythrocytic glycolytic pathways and membranes, and the ability to transport and deliver oxygen. T-cell lymphopenia is common among COVID-19 patients. The leukocytes produce excess inflammatory products during a “cytokine storm” where T and B lymphocytes, natural killer cells, neutrophils, and macrophages secrete pro-inflammatory cytokines to attenuate natural killer function to resolve inflammation. This further activates cytokine release from neutrophils and macrophages which, in turn, leads to exponential increase in inflammation, release of reactive oxygen species, superoxide anion, and nitric oxide, and associated tissue damage.   With respect to platelets, thrombocytopenia has been observed in COVID-19 patients. The virus infects bone marrow cells resulting in abnormal hematopoiesis, direct destruction of platelets associated with the cytokine storm and immune function, and increased platelet consumption and tissue damage caused by the virus. The function of blood cell populations is severely compromised by SARS-CoV-2, contributing to severe disease outcomes, such as tissue and organ damage, and death. As more information is available about the virus, vaccines and the effect on erythrocyte, leukocyte, and platelet pathophysiology, this infor¬mation will be used to develop new therapeutics to improve the recovery of patients from this disease.

 

Key words: COVID-19, SARS-CoV-2, erythrocytes, leukocytes, platelets

 

Int. J. Bio. Lab. Sci 2022(11)2:90-95 【PDF】

Review article: Advancements in Targeted Molecular Therapy for Human Papillomavirus (HPV) Related Cancer

 

Amanda Szymanski, Joel E. Mortensen, Patricia Tille

 

Abstract
Human papillomavirus (HPV) is a common sexually transmitted disease among both men and women. High risk cases can quickly develop into cancer, most frequently in the cervix and oropharynx. Standard treatment options include surgery and chemotherapy both of which are painful, hard on the body, and can leave the patient with long term side effects. Unlike traditional therapy methods, molecular targeted therapy focuses specifically on molecular changes making it more effective, highly specific, and more tolerable than more traditional methods. Molecular targeted therapy has shown promising results for various types of cancer. Recent developments for HPV specific cases have led to some exciting advancements in precision medicine.

Cetuximab and gefitinib are two recently developed molecular targeted therapy drugs that target epidermal growth factor receptors (EGFR) to deactivate molecular pathways responsible for cancer growth. Both drugs are proven to be safe and effective therapy options that can improve the patient’s overall survival and decrease disease recurrence. However, drug resistance remains problematic for patients using molecular targeted therapy. A common solution is combining molecular targeted therapy with additional options such as chemotherapy or other targeted therapies. This has the potential to eliminate drug resistance. However, there are limited target therapies available for HPV cancer. This demonstrates the need for further research and drug development for HPV related cancer cases to make further advancements.

 

Key words: Human papilloma virus; Cancer; Molecular targeted therapy; Molecular target identification; Oropharyngeal; Molecular detection; miRNAs; Epidermal growth factor signaling; Kinase inhibitors; Monoclonal antibodies; Cetuximab; Gefitinib; Resistance; T790M

 

Int. J. Bio. Lab. Sci 2022(11)2:71-79 【PDF】

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