Catlab Reports Bulletin
The Catlab Reports Bulletin is published monthly. Until the publication of the Catlab website, it was mailed electronically to our clients. It consists of a monograph related with laboratory topics. Each month it addresses a different area of Catlab; the topics can be more specific (concrete diagnostic techniques) or deal with more generic aspects (Quality, Management, …).
FMEA (Failure Mode and Effect Analysis)
The UNE-EN ISO 15189: 2013 laboratory accreditation standard establishes for accredited laboratories the obligation to evaluate work systems in order to detect possible errors that may affect patient safety. The FMEA (Failure Mode and Effect Analysis) methodology was used in Catlab. It is a simple but effective methodology that allows all personnel involved in the analytical process to be part of the procedure, thus facilitating not only the detection of potential errors but also the causes and preventive actions needed.
At Catlab, more than 100 potential errors have been detected and more than 78 corrective actions have been implemented to ensure patient safety and customer satisfaction.
Lessons learned from SARS-CoV-2 humoral immune response
SARS-CoV-2 serology, using antibody detection may be useful in several scenarios, where the detection of active infection (PCR) may not be sufficient, such as seroprevalence studies, diagnosis of patients with compatible symptomatology and negative PCR or in the control of vaccine efficacy, among other cases.
Catlab has carried out antibody detection using high-performance ELlSA techniques (chemiluminescence, CLIA), making serological diagnosis a very useful tool for a better understanding of humoral response to this new virus.
Anti-Müllerian hormone(AMH)- Aplications and quantification.
AMH is a glycoprotein belonging to the transforming growth beta factor superfamily. It has recently emerged as an early and accurate biomarker for ovarian reserve and ovarian aging assesssment. Thus, the determination of this hormone has various applications such as the diagnosis and follow-up of patients with polycystic ovary syndrome or ovarian granulosa cell tumors, among others. In men, its determination is also used for the study of hypogonadism or early puberty.
At Catlab during the year 2020, AMH test has been internalized, using Lumipulse Analyzer,by Fujirebio INC.
The determination is performed using a two-step chemiluminescent immunoassay method that will eventually generate a luminic signal proportional to the amount of AMH present in the sample.
Diagnosis and Follow-up of Paroxysmal Nocturnal Hemoglobinuria by Flow Cytometry
Paroxysmal Nocturnal Hemoglobinuria (PNH) is the name given to the disease caused due to an acquired genetic mutation in the PIG-A gene which results in the reduction or absence of membrane proteins of the affected hematopoietic cells.
This mutation affects proteins involved in the interaction with complement regulators (CD55 and CD59) .This loss of complement regulation is especially sensitive on red cells resulting on severe pathophysiology episodes of the disease by causing episodes of intravascular and extravascular hemolysis.
Flow cytometry is the method recommended by current clinical guidelines.By Marking membrane proteins of different hematopoietic series affected celular clones are detected ,thus allowing not only their diagnosis but also their follow-up and monitoring.
MICROBIOLOGY-Sexually Trasnmitted Diseases. Microbylogical diagnosis
Sexually Transmitted Infections (STIs) are a Public Health problem. Every year, approximately 500 million people suffer from chlamydia, gonorrhea, syphilis or trichomoniasis. The microbiological diagnosis of STIs allows not only to detect and treat symptomatic patients but also to detect asymptomatic contacts in order to prevent transmission and reinfection.
At Catlab, depending on each type of sample received a microscopic examination, microbiological culture and detection by nucleic acid amplification techniques are performed in order to optimize the detection of microorganisms involved in these diseases.
HEMATOLOGY-Detection of Hemoglobin variants in glycated Hemoglobin(HbA1c) studies in pregnant women
As a result of the Covid-19 pandemic,as a measure to reduce contagion, gestational diabetes detection protocols have been implemented. O'Sullivan test and Glucose curve have been replaced (they imply a extended stay in healthcare facilities) for HbA1c and Glucose.
At Catlab, HbA1c is determined by HPLC. Separation method that allows detecting most fractions of Hemoglobin present in the sample. If suspicious peaks are found, the study is extended using another HPLC analyzer and electrophoresis.
GENETICS - Array CGH in neurodevelopmental pathologies
The prevalence of neurodevelopmental pathologies in the general population is estimated at 1-3%. Genetic testing allows a more accurate prognosis. Today, conventional chromosomal analysis has been replaced by array comparative genomic hybridization (aCGH) techniques. At Catlab, since 2014 studies with the aCGH technique have been carried out, achieving good diagnostic performance. The good results are the product of the close relationship with the clinicians, the joint work in the diagnostic orientation, and the approach to be followed in each case, with the added value of the orientation towards the family counseling.
BIOCHEMISTRY - Possible interference by Biotin in some Laboratory tests
Biotin is a water-soluble vitamin that participates in cell proliferation, embryonic development, and in immunological and metabolic functions. It is commonly found in many foods, but also in some vitamin supplements. In 2017, the FDA warned about possible interference in some laboratory tests, due to the high presence of biotin. Catlab, following international recommendations, has been substituting some reagents to avoid possible interference with biotin.
GENETICS - Pharmacogenetic study of the variants of the DPYD Gene in cancer patients
Fluoropyrimidines are anticancer compounds that act as antimetabolites in chemotherapies of different tumors. Its administration has to be controlled very well, since an excess of metabolites can trigger toxicity. The elimination of these metabolites is mainly controlled by the activity of the DPD enzyme. The DPYD gene encodes the DPD enzyme. It is a highly polymorphic gene, and the detection of the variants allows to predict the enzymatic activity before starting the treatment, thus preventing the adverse effects of DPD deficiency. Thus, based on the variants found, a calculation is made of the patient's ability to metabolize fluoropyrimidines. With this, we can categorize the patients according to the metabolization capacity, and the standard drug dose can be corrected and personalized.
Immune response and COVID-19
The clinical presentations of COVID-19 range from asymptomatic forms to a syndrome with cytokine release, respiratory failure, and death. People over 60 years old and those with comorbidities, are more susceptible to developing a deficient immune response, unable to eliminate the virus, and responsible for cytokine release syndrome.
However, other host factors, some still unknown, and some likely genetic in nature, appear to confer susceptibility to complications.