Clinical Laboratory Research Articles

Clinical Characteristics and Diagnosis of Ph-Positive Mixed Phenotype Acute Leukemia.

The goal was to improve the clinical cognition of Ph-positive mixed phenotype acute leukemia and avoid misdiagnosis or delayed diagnosis. The clinical manifestations and laboratory results (bone marrow cell morphology, multiparameter flow cytometry, and cytogenetics) of a case of Ph-positive mixed phenotype acute leukemia were analyzed, and related literature was reviewed. Blood routine: WBC 386.35 x 109/L, HGB 117.00 g/L, PLT 31 x 109/L; 80% of the original cells can be seen by artificial classification. Morphological examination of bone marrow cells showed that the proliferation of nucleated cells was obviously active, and the original cells accounted for 76%. The size of the original cells was somewhat uniform, most of the cells had less mass, were stained light grayish blue, the cytoplasm particles were not obvious, the nuclei were mostly round or quasi-round, some of them showed distortion and nuclear notch, and the chromatin was coarse. Some of the cells were rich in mass, small azurin granules were seen, the nuclei were regular, most of them were round, the chromatin was fine, the myeloperoxidase and esterase staining were negative, the eosinophils accounted for 2.5%, and the basophils accounted for 0.5%. Flow cytometry immunotyping: Two groups of abnormal cells were seen in the bone marrow. 1. A group included 12.32% of nuclear cells and showed abnormal myeloid primitive cell phenotype. Main expression: CD117, CD34, CD38, HLA-DR, CD33, CD64, CD123, weak expression: CD13, CD19. 2. The other group included 45.61% of the nuclear cells and had a B-lymphoblastic phenotype. Main expression: CD34, CD38, HLA-DR, CD123, CD19, CD10, CD9, cCD79a, TDT, weak expression of CD13, CD22. Mixed phenotype acute leukemia (M/B) immunophenotype was considered. Chromosome: 46,XY,t(9; 22)(q34;q11.2) [20]. BCR-ABL (P210) fusion gene was positive. Mixed phenotype acute leukemia (MPAL) is a rare type of malignant hematologic disease. Its diagnosis is based on the comprehensive evaluation of bone marrow cell morphology, immunophenotype, molecular and cytogenetic features.

Evaluation of newborn screening program for maple syrup urine disease for optimization of amino acid ratio cutoffs: Experience from a single clinical chemistry laboratory

Evaluation of newborn screening program for maple syrup urine disease for optimization of amino acid ratio cutoffs: Experience from a single clinical chemistry laboratory

Sustainability and environmental impact of the clinical laboratory

Sustainability and environmental impact of the clinical laboratory

Development and field evaluation in African and Asian countries of an HBV PCR on open polyvalent platforms to determine treatment eligibility: results from the ANRS 12327 study

ObjectiveWidespread testing and treatment are essential to eliminate hepatitis B virus (HBV) infection as a public health concern. However, in resource-limited countries, access to HBV PCR is limited. In this study, we developed a quantitative HBV PCR assay on open molecular platforms and evaluate its performance in diagnosing clinically significant HBV DNA thresholds as defined by the World Health Organization (WHO) (2,000 IU/mL, 20,000 IU/mL, and 200,000 IU/mL). MethodsWe implemented our HBV PCR test in seven African and Asian countries and France, using either an in-house laboratory method or a CE-IVD marked version of the PCR (Generic HBV Charge Virale, Biocentric). Results were compared to reference tests (Roche Cobas AmpliPrep/Cobas TaqMan and Abbott RealTime on Abbott m2000). ResultsThere was a good agreement between the HBV DNA results of 1015 samples tested by the PCR on open polyvalent platforms and the results from reference tests (mean difference [bias ± SD]: -0.3 ± 0.7 log10 IU/mL and -0.2 ± 0.9 log10 IU/mL when compared to Roche and Abbott tests, respectively). Kappa-Cohen agreements between the HBV PCR on open polyvalent platforms and the Roche/Abbott assays appeared almost perfect for HBV DNA levels ranged from >20,000 to 200,000 IU/mL and >200,000 IU/mL, substantial and moderate for HBV DNA levels ranged from 2,000 to 20,000 IU/mL when compared to Abbott and Roche, respectively. The assay's performance was consistent across genotypes A, B, C, D, and E. ConclusionThis field evaluation showed that our HBV PCR test is a valuable alternative to proprietary PCR systems. PCR assays on open platforms contribute to expanding clinical laboratory solutions for diagnosing individuals who meet the viral load criteria for antiviral therapy (>20,000 IU/mL) and mother-to-child prophylaxis (>200,000 IU/mL).

Relevance of clinical laboratory in rare adrenocortical tumors diagnosis. Case report

Relevance of clinical laboratory in rare adrenocortical tumors diagnosis. Case report

Clinical laboratory correlation & communication-the ultimate tool in diagnostic quality

Clinical laboratory correlation & communication-the ultimate tool in diagnostic quality

The role of nurses and midwives in medical laboratory investigations in sub-Saharan Africa.

Across the globe, nurses and midwives play a crucial role in providing care to patients in healthcare facilities. They often contact the patient, providing direct care as directed by medical doctors or clinical officers. Traditionally, the role of nurses and midwives in the clinical diagnosis process is to coordinate the clinical diagnosis process-which includes laboratory diagnosis requests-from diagnosticians to the clinical laboratory. In these settings, these diagnosticians are general or specialist medical doctors. However, in some regions in sub-Saharan Africa (SSA), nurses and midwives are primary diagnosticians in healthcare facilities. We present a perspective on the role of nurses and midwives in medical laboratory investigations in SSA. We highlight how, on top of nursing and midwifery roles, nurses take up the role of diagnosticians in facilities where doctors are few or are absent and what key issues are worth consideration. Furthermore, we present how efficient collaboration between nursing midwifery and medical laboratory diagnostic systems facilitates effective patient management. Emphasizing training on laboratory test utilization for nurses and midwives in SSA is vital for enhancing healthcare outcomes.

Assessing good clinical practices in a clinical laboratory of a tertiary healthcare institute by evaluating key performance indicators of pre-analytical phase

Assessing good clinical practices in a clinical laboratory of a tertiary healthcare institute by evaluating key performance indicators of pre-analytical phase

Clinical laboratory management of a nesidioblastosis case

Clinical laboratory management of a nesidioblastosis case

Results of a Pilot External Quality Assessment Scheme for Genetic Testing of Newborns with Spinal Muscular Atrophy.

This study aims to evaluate the ability of laboratories to perform spinal muscular atrophy (SMA) genetic testing in newborns based on dried blood spot (DBS) samples, and to provide reference data and advance preparation for establishing the pilot external quality assessment (EQA) scheme for SMA genetic testing of newborns in China. The pilot EQA scheme contents and evaluation principles of this project were designed by National Center for Clinical Laboratories (NCCL), National Health Commission. Two surveys were carried out in 2022, and 5 batches of blood spots were submitted to the participating laboratory each time. All participating laboratories conducted testing upon receiving samples, and test results were submitted to NCCL within the specified date. The return rates were 75.0% (21/28) and 95.2% (20/21) in the first and second surveys, respectively. The total return rate of the two examinations was 83.7% (41/49). Nineteen laboratories (19/21, 90.5%) had a full score passing on the first survey, while in the second survey twenty laboratories (20/20, 100%) scored full. This pilot EQA survey provides a preliminary understanding of the capability of SMA genetic testing for newborns across laboratories in China. A few laboratories had technical or operational problems in testing. It is, therefore, of importance to strengthen laboratory management and to improve testing capacity for the establishment of a national EQA scheme for newborn SMA genetic testing.

Evaluating data accuracy in clinical laboratory requests: A therapeutic drug monitoring study

Evaluating data accuracy in clinical laboratory requests: A therapeutic drug monitoring study

Severe hypercalcemia: Clinical laboratory differential diagnosis

Severe hypercalcemia: Clinical laboratory differential diagnosis

Clinical laboratory decision support system for quality test ordering and utilization with increase reimbursement

Clinical laboratory decision support system for quality test ordering and utilization with increase reimbursement

4. The evolution of human biomonitoring and its impact on clinical laboratory medicine

4. The evolution of human biomonitoring and its impact on clinical laboratory medicine

The role of the clinical laboratory in the diagnostic guidance of paediatric patients with acute lymphoblastic leukaemia

The role of the clinical laboratory in the diagnostic guidance of paediatric patients with acute lymphoblastic leukaemia

Insight into the status of plasma renin and aldosterone measurement: findings from 526 clinical laboratories in China.

Accurate measurements of renin and aldosterone levels play an important role in primary aldosteronism screening, which is of great importance in the management and categorization of hypertension. The objective of this studyis to investigate the current status of plasma renin and aldosterone measurements in China, which is achieved by analyzing the results of 526 clinical laboratories nationwide for three pooled fresh plasma samples derived from more than 2,000 patients. Renin and aldosterone in three pooled plasma samples were measured four times in 526 laboratories employing various measurement systems. The inter- and intra-laboratory %CV were calculated and compared. To determine the source of the substantial inter-laboratory %CV,laboratories were categorized according to the measurement systems they are using, and both the inter- and intra-measurement-system %CV were calculated and compared. Regarding renin, the majority of laboratories use four primary commercial immunoassays. However, for aldosterone, in addition to commercial immunoassays, laboratory-developed liquid chromatography-tandem mass spectrometry (LC-MS) methods are also used by laboratories. The median values of intra-laboratory %CVs, intra-measurement-system %CVs, inter-laboratory %CVs, and inter-measurement systems %CVs varied between 1.6 and 2.6 %, 4.6 and 14.9 %, 8.3 and 25.7 %, and 10.0 and 34.4 % for renin, respectively. For aldosterone, these values ranged from 1.4 to 2.2 %, 2.5-14.7 %, 9.9-31.0 %, and 10.0-35.5 %, respectively. The precision within laboratories and measurement systems for plasma renin and aldosterone measurements is satisfactory. However, the comparability between laboratories using different measurement systems remains lacking, indicating the long way to achieve standardization and harmonization for these two analytes.

Evaluation of toxoplasma IgG avidity results and their correlation with toxoplasma Gondii IgM and IgG, in pregnant women during the first trimester at American Hospital, International Hospital and Cambridge Clinical Laboratories, Albania

Evaluation of toxoplasma IgG avidity results and their correlation with toxoplasma Gondii IgM and IgG, in pregnant women during the first trimester at American Hospital, International Hospital and Cambridge Clinical Laboratories, Albania

Correlation between common mutations of MTHFR gene and missed abortion cases, during the first trimester of pregnancy, at American Hospital, International Hospital and Cambridge clinical laboratories in Albania

Correlation between common mutations of MTHFR gene and missed abortion cases, during the first trimester of pregnancy, at American Hospital, International Hospital and Cambridge clinical laboratories in Albania

Validation of a qualitative real-time PCR assay for the detection of Candida auris in hospital inpatient screening.

This study overviews the validation and implementation of a molecular screening tool for the detection of Candida auris in a College of American Pathologist-accredited clinical laboratory. This molecular laboratory-developed test is both highly sensitive and specific and has significant health-system cost-savings associated with significantly reduced turn-around-time compared to traditional standard-of-care culture-based work up. This method and workflow is of interest to support clinical microbiology diagnostics and to help aid in hospital inpatient, and infection prevention control screening.

The technology for clinical laboratories in 21st century: Challenges and opportunitie

The technology for clinical laboratories in 21st century: Challenges and opportunitie