Private Laboratories Research Articles

P-1505. Impact of the Introduction of Ceftazidime-Avibactam in the Brazilian Market on Carbapenem and Ceftazidime-Avibactam Resistance in Klebsiella pneumoniae and Pseudomonas aeruginosa: Retrospective Analysis from 2017 to 2023

Abstract Background Bacterial resistance to carbapenems, poses a global health challenge, with Klebsiella pneumoniae and Pseudomonas aeruginosa as significant contributors. Ceftazidime-avibactam (CZA), introduced in Brazil in June 2018, offers a new treatment option for multi-resistant infections. However, increasing resistance to both this drug and carbapenems raises concerns. Our goal is to evaluate the impact of CZA introduction on resistance patterns, and metallo-betalactamases (MBL) prevalence in Brazil, focusing on K. pneumoniae and P. aeruginosa. Methods A retrospective analysis of microbiology data from a Private Laboratory (2017-2023) was conducted. Samples from 9 Brazilian states were assessed. We included all positive blood cultures and all resistant surveillance swab cultures for K. pneumoniae and P. aeruginosa. We excluded repeated positive blood cultures in a week interval with the same agent, and we considered only the first positive resistant surveillance culture. We considered carbapenem-resistant if the isolate was resistant to any carbapenem. It was evaluated phenotypically or genotypically and carbapenemase production patterns were aggregated into 3 categories: serine-, MBL, or co-production. We used Poisson regression model with a robust error variances variance to compare pre- and post-CZA introduction resistance prevalences. The models were adjusted for COVID-19 national incidence, age, and gender. Results We analyzed 9361 positive blood and 16862 carbapenem-resistant surveillance cultures. In blood cultures, CZA resistance rose after its introduction in K. pneumoniae (3% to 9%; 2019 to 2023 (p < 0.001), so did the MBL production (0% to 6%, p 0.02), and serine- and MBL co-production: 0% to 1% (p 0.04). MBL also increased in P. aeruginosa during the study period: 0% to 4% from 2017 to 2023 (p < 0.001). In surveillance cultures, carbapenemase production increased in P. aeruginosa after CZA introduction: 5% to 22%, p < 0.001. Conclusion The observed increases in resistance prevalence and carbapenemase production associated with CZA introduction indicate limitations for its use. Enhanced surveillance and antimicrobial stewardship strategies are urgently needed to address the growing threat of antimicrobial resistance. Disclosures All Authors: No reported disclosures

Cross-sectional, laboratory-based study of measles seroprevalence in Oman

Background: Since the introduction of vaccination in Oman in 1981, measles incidence has decreased, and Oman achieved measles elimination in 2019. Measles cases in the country are currently import-related. Aim: To understand the measles immunity profile of the Omani population and identify high-risk groups. Methods: A total of 1990 anonymous blood samples out of 2032 samples collected from all regional referral hospitals and one private laboratory in Oman from November 2015 to January 2016 were tested for measles immunoglobulin G. We grouped the study population into 4 birth cohorts and analysed the data using SPSS version 16.0. We used the χ2 to test for statistical significance and used Kruskal-Wallis test to calculate the geometric mean for each age group. P < 0.05 was considered statistically significant. Results: The overall measles seropositivity was 84.0%. Seronegativity was significantly higher among the 15–20 years (34.0%) and 20–35 years (24.0%) age groups. There was no significant difference in seropositivity by gender and nationality. Seropositivity was 72.7% in the 1987–1996 cohort and 70.1% in the 1997–2006 cohort. The mean measles antibody level was 2318.5 IU/ml Conclusion: This study revealed a measles immunity gap among some age groups in Oman, indicating the need for sustained high vaccination coverage, robust surveillance, targeted vaccination campaigns, and timely outbreak response

Epidemiology of malaria and hematological analysis in district Dir (lower), Pakistan

Background: Malaria is considered as a tropical disease, in developing countries. Among all parasitic infections malaria is most widespread and devastating disease. According to WHO malaria is endemic in 24 countries. Methods: This cross-sectional study was conducted at Department of Medical Laboratory Technology University of Haripur. Total 995 samples were collected at District Head Quarter Hospital (DHQ), Tehsils Hospitals (THQs), and other private laboratories in District Dir (Lower). These samples were processed to observe the shape of RBCs as well as plasmodium species in the smear microscopically, and for hemoglobin estimation. Data was analyzed through SPSS version-21. Results: Highest percentage of malaria was recorded in Munda (35.17%) followed by Timergara (19.59%) whereas the lowest number of cases were found in Khall (5.02%). Prevalence of P. vivax was (98.0 %) and P. falciparum was (2 %) in district Dir Lower. Mean red blood cell count (RBCs) was 4.2±0.64 mm3 while mean Hb was 11.0±1.99g/dl. Based on different age categories, the highest RBCs and Hb levels were found in age group 41-50 years, whereas the lowest RBCs were found in age group 11-20 years while the lowest Hb levels were recorded in group 1-10 years. In associated diseases, the upper respiratory tract infections (URTIs) were the most frequent (20%) followed by diarrhea (18%). Mean Hb of males was 11.8±1.53 g/dl while the mean Hb of female was 11.5±5.384 g/dl. Hb in both males and females were low as compared to the standard. However, as compared to females, Hb of males were significantly lower with p-value <0.001. Conclusion: We concluded that males are more commonly infected from malaria as compared to females. Males and children were found to have low Hb as compared to females and higher age group patients. URTIs and diarrhea were the most common associated illness.

Laboratory readiness and genomic surveillance of Covid-19 in the capital of Brazil.

This study aims to analyze the diagnostic readiness to Covid-19 and the genomic surveillance of SARS-CoV-2 in Brasília, the capital of Brazil. This is a retrospective, cross-sectional study, with data from: cases/deaths-Ministry of Health; RT-PCR analyses Brasília Central Public Health Laboratory (LACEN); genomics-Global Initiative on Sharing All Influenza Data (GISAID). It was found that in March 2021, with the Gamma variant was predominant, RT-PCR diagnostic tests administered by LACEN reached their peak, followed by a reduction, possibly due to the start of vaccination. New peaks were observed in September 2021 and January 2022. The average time for releasing RT-PCR results was reduced from eight days (July 2020), to around eight hours in 2023. The participation of private laboratories was evident in sequencing the SARS-CoV-2 variants of concern in Brasília (n = 1,897). LACEN sequenced 50% of the samples received (571). A decrease in the incidence of cases and deaths due to Covid-19 was noted in the years 2022 to 2023, following the national trend. LACEN maintained RT-PCR diagnostic tests administered satisfactorily throughout the period. Regarding the genomic surveillance of SARS-CoV-2, the vast majority of samples were sequenced by private laboratories when compared to the public laboratory.

Antimicrobial susceptibility of gram-negative bacteria: analysis from patients in a laboratory network in Brazil.

This study aimed to describe the epidemiology and antimicrobial susceptibility patterns of gram-negative pathogens in Brazil from 2018 to 2020, addressing the gap in national data on healthcare-associated infections, using information from a private laboratory network. A cross-sectional study was conducted using a database from Fleury hospital network, a private laboratory in Brazil. The analysis included blood, urine, and lower respiratory tract samples collected from January 2018 to June 2020. The study included consecutive non-duplicated isolates of Enterobacterales or P. aeruginosa from inpatients aged ≥18 years old. Bacterial identification was performed using mass spectrometry, and antimicrobial susceptibility was determined following EUCAST/BrCAST guidelines. A total of 25,180 isolates were included in the analysis. Most of the sample consisted of female patients (57.9%), with a mean age of 70 years (SD 18.1). Enterobacterales were the most prevalent pathogens found (76.2%), while P. aeruginosa was present in the remaining 23.8%. In terms of antimicrobial susceptibility, Enterobacterales exhibited a higher susceptibility rate to ceftazidime/avibactam (97.1%) and amikacin (95.6%), while P. aeruginosa showed a higher susceptibility rate to polymyxin B (97.1%) and ceftolozane/tazobactam (86.6%). Among carbapenem-resistant P. aeruginosa isolates, 75% were susceptible to ceftolozane/tazobactam. Additionally, 24.2% of K. pneumoniae complex samples were identified. Enterobacterales was the most frequently encountered group in Brazil. Ceftazidime/avibactam and amikacin demonstrated the highest efficacy against this group, while ceftolozane/tazobactam and polymyxin had the highest efficacy against P. aeruginosa. This highlights the importance of new β-lactam-β-lactamase inhibitor combinations for the treatment of gram-negative infections.

Investigative genetic genealogy practices warranting policy attention: Results of a modified policy Delphi.

A technique known as investigative genetic genealogy (IGG) was first introduced to criminal investigations in 2018, and it has since been used by U.S. law enforcement to help identify hundreds of criminal perpetrators and unidentified human remains. As expertise in IGG grows, policymakers have shown interest in regulating it. To help inform these efforts and to promote coherence in IGG governance as it expands, we recruited experts representing a spectrum of IGG-relevant professions and perspectives to identify and prioritize IGG practices for policy attention and to develop policy options for addressing them. In two rounds of a modified policy Delphi, 31 participants prioritized nine IGG practices for policy attention. These top priority practices relate to: consent and notification; case eligibility and criteria; data management, privacy, and security; and governance and accountability. Participants expressed a range of opinions, some strongly held, and did not reach complete consensus with respect to any of the practices. However, convergence was strongest with respect to law enforcement participation in direct-to-consumer genetic genealogy databases against terms of service, which a large majority opposed and almost half evaluated as top priority for policy attention. Participants also voiced strong and consistent concern about management of data and samples collected and generated during IGG and the governance of private laboratories involved in IGG. Our study demonstrates the feasibility and value of engaging with diverse experts over an extended period on a pressing matter of public policy and provides a needed empirical foundation for IGG policymaking.

Diagnostic Accuracy of Enzyme-Linked Immunosorbent Assay Compared with Polymerase Chain Reaction in Diagnosing <i>Helicobacter pylori</i> in Patients with Gastric Problems

Background: Helicobacter pylori, identified in 1982, is a significant gastric pathogen affecting a large portion of the global population. Objectives: This study aims to compare the diagnostic accuracy of enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) methods for detecting H. pylori, which is crucial for improving treatment strategies for gastric disorders. Methods: The study involved 70 patients at Khurshid Private Laboratory in Tehran between July and September 2022. The goal was to identify H. pylori DNA in stool samples using real-time PCR, while simultaneously testing serum samples for H. pylori using the ELISA method. Data were analyzed using SPSS software. Results: In a study of 70 patients with stomach diseases, the prevalence of H. pylori infection based on PCR results was 24.29%, with a slightly higher prevalence in females than males. For diagnosing H. pylori infection, the optimal IgA cut-off point was identified as 7.15 mg/dL, yielding a sensitivity of 88%, specificity of 89%, and an AUC of 0.94. The optimal cut-off for IgG was 95.70 mg/dL, with a sensitivity of 76%, specificity of 94%, and an AUC of 0.88, using PCR results as the gold standard. Conclusions: This study emphasizes the importance of accurately diagnosing H. pylori infections, highlighting that PCR offers greater sensitivity and specificity than ELISA. By establishing optimal IgA and IgG cut-off points, the study enhances diagnostic precision, which could lead to improved therapeutic interventions and patient outcomes.

A Cross-Sectional Study of Antimicrobial Resistance Pattern Across Two States in Nigeria

Antimicrobial resistance has been declared by the World Health Organization as a threat to countries and across various sectors. This study aimed to analyze antimicrobial resistance patterns of the common pathogens occurring in the Federal Capital Territory and Lagos states of Nigeria. A retrospective analysis of microbiological culture results from five private and public laboratories between January and April 2016 in Lagos and the Federal Capital Territory (FCT). A total of 544 isolates were obtained from the five laboratories. Urine 137 (25.2%), was the most prominent specimen, followed by Stool 64 (11.7%). Out of 374 specimens that yielded growth after culture, gram-negative isolates were the most prevalent bacteria 169 (56%). There were significantly more samples from FCT and by gender (P=0.03) compared to Lagos (P=0.0003). There was no significant association between the type of bacteria isolate and location. The predominant gram-positive bacteria were Staphylococcus aureus 94 (70%), while gram-negative bacteria were Klebsiella species 67 (40%). Multi-drug resistance was observed in 202 (62%) of isolated urogenital pathogens. Maximum resistance was observed with commonly used first-line antimicrobials such as cotrimoxazole, tetracycline, second-generation cephalosporins -Cefotetan, and third generation Cephalosporins -Ceftriaxone. Staphylococcus aureus had the highest antimicrobial resistance expression (93.6%) within the gram positives, with multiple drug resistance to all the antibiotics. Our survey revealed a rising rate of antimicrobial resistance to commonly used antibiotics. We recommend the prudent use of antibiotics to limit the spread of antimicrobial resistance.

Evaluating Communication Practices between Dentists and Dental Technicians

Objectives: To evaluate the effectiveness of current communication practices and the understanding of technicians regarding written prescriptions. Methodology: This Questionnaire based cross-sectional study was conducted in Lahore, from Aug 2023 to May 2024, to assess communication quality between dentists and dental technicians. The sample consisted of 50 dental technicians currently employed in ten different private and public dental laboratories in Lahore, Punjab. The selection of participants was carried out using non-probability convenient sampling. Undergraduate students pursuing dental technology were excluded from the study to maintain a focus on experienced professionals who actively participate in dental restoration processes. Data were collected using a modified standardized questionnaire, including items on demographics and communication quality. Data was collected, reviewed for completeness, and analyzed using SPSS v24. Results: Most dental technicians (n=38, 68%) possess a BSc degree in dental technology with work experience ranging from 1 to 45 years. Communication preferences varied notably across workplace settings. About 46% (n=23) of the technician favored direct communication. There was a significant difference in communication modes between these settings (p=0.001), with a preference for personal visits, particularly among technicians from teaching institutes (n=23, 88.5%). The majority (n=42, 84%) reported positive receptivity from dentists, and 62% (n=31) indicated that communication was encouraged, particularly in teaching institutes. Issues regarding blank prescription cards were mixed, with 36% (n=18) never receiving them and 50% (n=25) consulting clinicians in such cases. Only 36% (n=18) of technicians felt they received sufficient information. Conclusion: Most technicians prefer direct communication from dentists, particularly in teaching institutes, compared to those in commercial labs who favor phone calls. A major concern was the lack of sufficient information and blank patient prescriptions from dentists. Addressing these gaps through standardized protocols, modern digital tools, and enhanced training can improve patient outcomes.

Anti-competitive behaviour amid the Covid-19 pandemic: liability of private laboratories and a business association (Portugal)

Anti-competitive behaviour amid the Covid-19 pandemic: liability of private laboratories and a business association (Portugal)

Immunohistochemical Expression of COX2 in Urothelial Carcinoma of the urinary bladder

Background and objectives: Urothelial carcinoma of urinary bladder constitutes 90% of bladder cancer cases. Cyclo-oxygenase 2 as an immune-histochemical marker, is not expressed in normal tissues, while it is expressed in some cancers including urothelial carcinoma. The purpose of this study is detecting the frequency of expression of Cyclo-oxygenase 2 in urinary bladder’s urothelial carcinoma in association with certain clinicopathological variables. Methods: A retrospective study was done on seventy-nine cases (fixed with formalin and embedded in paraffin) of urothelial carcinoma which were chosen haphazardly from a private laboratory in Erbil city over two years (between October 2019 to October 2021). In the present study, Cyclo-oxygenase 2 expression was assessed on the urothelial carcinoma slides. Results: Cyclo-oxygenase 2 was positive in 45.6% of the cases. It was positive in 80% of non-papillary tumors, while it was less expressed (40.6%) in papillary tumors, which means that significant correlation was seen between Cyclo-oxygenase 2 positivity and tumor pattern (papillary vs non-papillary) (p = 0.037). In this study, no important association was found between Cyclo-oxygenase 2 expression and other clinicopathologic features like age (p=0.236), gender (p=517), tumor grade (p=0.106), lymphovascular invasion (p=0.696) and T stage (p=0.061). Conclusion: In this study Cyclo-oxygenase 2 was expressed in less than half of our urothelial tumor samples. A strong association was found between Cyclo-oxygenase 2 positivity and tumor pattern (papillary and non-papillary), but no important association was found between Cyclo-oxygenase 2 positivity and other variables such as age, gender, tumor grade, lymphovascular invasion and tumor stage.

The Impact of Healthcare Policies on Medical Laboratories in Saudi Arabia

In the last decade, there has been a considerable increase in the demand for laboratory services in Saudi Arabia. Healthcare policy in Saudi Arabia has continued to aggressively encourage developments in private laboratories.

How Do Time Since Diagnosis and Sociodemographic Factors Influence Attitudes Towards HIV Status Disclosure in People Living with HIV in Poland? Data from Go Holistic Go Beyond Project.

The aim of this publication is to present the data from Polish respondents of the Go Holistic Go Beyond Project, which investigates social, professional and intimate relations of people living with HIV in Central and Eastern Europe. We analyze how the patients' attitude towards disclosing their HIV status changes over time from diagnosis. A questionnaire was distributed among patients by three HIV out-patient clinics. Respondents were compared in three groups defined by the time from diagnosis: over 10 years ago, 6-10 years ago and within 5 years. In total, 381 persons living with HIV participated in the survey, 354 of respondents were male, 23 were female and 4 of the respondents did not identify with any of the above sexes. A significant decrease in hospital-diagnosed cases (from 53% to 39%) was observed, alongside an increased role of private laboratories and voluntary counseling and testing centers. Eighty-nine percent of participants shared their HIV status with at least one social group. There was no significant change in the patterns of HIV status disclosure, reason and form of HIV testing. Our results emphasize the importance of survey-based studies in identifying the needs of people living with HIV in order to improve their general well-being.

Survey of clinical microbiology and infectious disease testing capabilities among institutions in Africa.

Inadequate laboratory infrastructure and testing capabilities are a major impediment to addressing the infectious disease burden in Africa. Therefore, the aims of this study were to characterize the clinical microbiology/infectious disease laboratory capabilities among countries in Africa. A survey to assess the microbiological testing capabilities at hospitals, government laboratories, and free-standing public and private laboratories in African countries was developed by subject matter experts. Questions included institutional demographics and microbiology services in the broad categories of bacteriology, virology, mycology, parasitology, and rapid diagnostics/point-of-care testing. The survey was distributed using the American Society of Clinical Pathology email listserv between June and August 2022. In total, 131 unique institutions in 28 countries endorsed at least 1 type of microbiology service, with parasitology (80.9%, 106/131) and bacteriology (77.9%, 102/131) being most common, while mycology (45.0%, 59/131) and virology (45.8%, 60/131) laboratories were less prevalent. The most frequently performed bacteriology test was bacterial identification (90.2%, 92/102), followed by aerobic bacterial cultures and antimicrobial susceptibility testing (both 89.2%, 91/102). Among all clinical microbiology/infectious disease laboratories, the most commonly tested agents were HIV (90.8%, 119/131), Treponema pallidum (78.6%, 103/131), Plasmodium falciparum (76.3%, 100/131), Mycobacterium tuberculosis (76.3%, 100/131), and hepatitis C virus (74.8%, 98/131). These findings provide contemporary data regarding the availability of critical infectious disease testing capabilities among institutions in Africa. These results and future additional studies will be crucial for understanding where strategic investment in the laboratory and public health infrastructure is warranted.

Simplifying acquisition of essential diagnostics: A comprehensive costing tool for anatomic pathology.

Histopathology is the core diagnostic tool for cancer in pathology laboratories around the world, but there are disparities in access to diagnostics globally. As recognition of the need for cancer care and treatment grows, especially in the wake of World Health Organization programs for cervical, breast, and pediatric cancers, policymakers and health care funders are seeking tools and processes that allow for the largest number of patients to receive a diagnosis at the lowest cost. As histopathology represents the most cost-effective diagnostic method by sheer number of tumor types and volume, understanding the detailed logistics and costs for histology as well as the impactful benefits of economies of scale (ie, larger volumes are less expensive per patient) and scope (ie, the multiple stains available after basic histology sectioning) is paramount to planning an effective publicly funded or government laboratory. Understanding the economic structure of a country's population along with the financial model of a histology laboratory also leads to a market understanding of private laboratories, which can provide services at a profit as well as pro bono services more cost-effectively than purely public laboratories. We have developed a comprehensive, scalable costing tool of a functioning histology laboratory that accounts for all feasible costs and variations in models of service. The tool allows for a standardized approach to selecting goods needed to provide histology services and serves as a guide for implementation of pathology services. Using the tool, laboratories can achieve self-sustainment and long-term financial health while incorporating a proportion of impoverished patients who cannot afford out-of-pocket expenses.

Evaluation of HbA1c, C-peptide and Rf in DM patients related to COVID-19, ABO group and BMI in Babylon, Iraq

Background: A total of 30(100%) cases of diabetes mellitus DM were collected from a private laboratory during the period from October 2023 to February 2024, compared with 30 control to evaluate several parameters in a case-control study. The demographic information of sex distribution for DM cases appear 16(53%) male and 14(47%) and the mean±SD of the age was 45.6±14.7 compared to the control 33.6±10.5 which reveals a significant at P = 0.0006. The mean±SD of the BMI was 29±6.4 in DM cases compared to the control 25.8±3.4 which reveals a significant difference at P = 0.0187. Distribution of DM types appears in 16(53%), and 14(47%) cases of DM type 1 and 2 respectively with no significant difference between the two study groups. The mean±SD of HbA1c Level with DM Patients and was 9.2±2.8 compared to the control 5.6±0.9 which appeared a significant at P = 0.0002. Methods: Evaluation of C-peptide Level appears the mean±SD of the C-peptide for DM cases was 5.7±4.5 compared to the control 3.3±2.4. this case-control study appeared a significant difference at P = 0.0125. RBS Level mean±SD of DM cases was 275.7±121.5 compared to the control 103.7±16.6. this case-control study appeared significant at P = 0.0001. The distribution of DM cases in blood groups O+, A+, B+, AB+, AB-, and O- was 10(33.3%), 8(26.7%), 5(16.7%), 3(10%), 3(10%), 1(3.3%), respectively. Results: All the cases in the present study show negative results for rheumatoid factor and there is no correlation between RF and DM. 2(7%) DM cases have a cardiac problem while the other 28(93%) don’t suffer from any cardiac problem. Relationship between COVID-19 and DM Type-1 Patients appears 15(50%) have positive COVID-19, 12(40%) has DM type 1 and 3(10%) has DM type-2. Conclusion: The study was concluded an appositive relationship between age, HbA1c, C-peptide, RBS, O+ and A+ blood groups and developments of diabetes mellitus.

Comparative Phenotypic and Genotypic Properties of Serratia marcescens Isolates from Clinical Cases from human in AL-Diwaniyah Province, Iraq

Serratia marcescens is a Gram-negative, rod-shaped bacterium. It is an opportunistic and facultative anaerobe. This study aims to determine the occurrence rates of Serratia marcescens in human clinical samples, investigate the pigM gene, sequence the isolates, and compare them with global isolates documented in the NCBI database. Fifty burn samples were collected from the specialized center for burns in AL-Diwaniyah province, along with 35 urine samples from individuals suffering from UTIs from Al-Diwaniyah Teaching Hospital and various private laboratories. These samples were transferred in a cooled container to the microbiology lab at the Veterinary Medicine College, University of Al-Qadisiyah, for bacteriological assay. The samples were then cultured using selective and differential media. Following the purification of the cultured bacteria, biochemical tests were conducted to confirm the isolates. Results showed that 10 out of 85 samples (11.76%) were positive for Serratia marcescens. Culture positivity was most frequent in urine samples (17.1%), followed by burn samples (8%). Molecular methods revealed that human isolates gave 100% positive results for 16S rRNA. The study found that ten isolates of Serratia marcescens possess the pigM gene, with the 16S rRNA gene sequenced using the BLASTN algorithm of NCBI. All isolates were recorded under accession numbers (OR835629, OR835630, OR835631, OR835632, OR835633, OR835634, OR835635, OR835636, OR835637 and OR835638, showing 97-99% identity with isolates detected in China, India, and Nigeria. It can be concluded that the isolation rates of Serratia marcescens from urine samples are higher than those from burn samples. The sequencing results showed a 97-99% similarity with global isolates from China, India, and Nigeria.

Distribution of HPV genotypes in Mashhad, Iran: insights from a 2022–2023 study

BackgroundHuman papillomavirus (HPV), is one of the main causes of cervical cancer and also one of the most common sexually transmitted infections (STIs). HPV is responsible for almost all cases of cervical cancer and plays a principal role in causing other cancers including oropharynx, penis, larynx, oral cavity, anus, vulva, and vagina. The study aims to investigate the prevalence and distribution of HPV genotypes among patients referred to private laboratories in Mashhad, located in the northeast of Iran.Methods and materials428 samples including 382 females (89.3%) and 46 males (10.7%) between January 10, 2022, and February 11, 2023, in Mashhad, Iran were evaluated to detect HPV and determine its genotypes. Cervical swabs and urine samples were collected from females and males, respectively. Viral DNA was extracted by using a CedExtra purification kit (cedbio, Iran) and viral genotypes were identified with a High + Low Papillomastrip kit (Operon, Spain). Mann Whitney U test and Chi-square test were accomplished for statistical analysis.ResultFrom the total of 428 participants analyzed, the HPV test result was positive for 129 patients (30.1%) and negative for 299 people (69.9%). Among the participants, 115 female (30.1%) and 14 male (30.4%) were positive for HPV infection. The prevalence of HPV infection among the referring people was about 30%. The most common genotype identified was HPV-6 (10.3%), followed by HPV-16 (8.7%) and HPV-51 (7.7%), the second and third most common genotypes, respectively. Additionally, HPV-39 was detected at a frequency of 6.70%. HPV-11, HPV-61, HPV-91, and HPV-44 with a frequency of 1% were among the least genotypes identified among the patients.ConclusionIn line with the results of this study, the prevalence of HPV genotypes in both genders is 30%. The results likely reflect differences in the prevalence of high-risk HPV genotypes, that are less common. Also, HPV-6 and HPV-16 genotypes that are covered by the vaccine had a significant prevalence. On the other hand, with the prevalence of HPV-51 and HPV-39 genotypes in infected people who are not covered by the Gardasil (quadrivalent) vaccine, there is a risk of related cancers in the future.

B-109 Six Sigma Analysis for Enhancing Biochemistry Internal Quality Control in a Private Laboratory in India

Abstract Background This abstract outlines a comprehensive study on the application of Six Sigma methodologies to optimize internal quality control processes in a private biochemistry laboratory in India. Data collection was performed using Bio-Rad Assayed Chemistry Control on the Roche cobas 6000 instrument, facilitated by Bio-Rad Unity software. The study adheres to Clinical Laboratory Improvement Amendments (CLIA) 2024 guidelines, specifically focusing on Total Error (TEa). Methods The analytical performances of Cobas c501 insturment as analyse by running biochemical tests (urea, creatinine, uric acid, total bilirubin, AST, Amylase, Lipase, CK, LD, ALT, ALP, LDH, HDL-C, Ca2+, cholesterol, TG, HDL LDL, total protein, albumin, Na+, K+, and Cl−) and glucose on Cobas 400 were evaluated. Biases and CV were obtained from internal quality control programs using biorad unity software. The performance of each instrument was assessed using the σ scale; the benchmark performance was <3 σ (improvement needed); “world-class” quality was six sigma. Results Analytes such as “Alk PO4,” “ALT,” “Amylase,” “Bilirubin,” “CK,” “GGT,” “LD,” “Phosphorus,” “HDL,” “LDL Cholesterol,” “Triglycerides,” and “Uric acid” exhibited impressive sigma scores exceeding 6. Meanwhile, analytes including “Calcium,” “Total Cholesterol,” “Potassium,” “Total Protein,” “Urea,” and “Glucose” achieved sigma scores between 4 and 6, demonstrating noteworthy performance within acceptable bounds. Conclusions This study contributes valuable insights to laboratory management, specifically in the context of biochemistry testing in private Indian laboratories. The adoption of Six Sigma principles, coupled with adherence to CLIA 2024 guidelines and the utilization of advanced instrumentation and software, ensures compliance with regulatory requirements and fosters a culture of continuous improvement. This positions the laboratory to deliver high-quality and reliable results in the dynamic landscape of healthcare diagnostics.

A-072 Growth hormone stimulation tests: experience of a large cohort from a Brazilian diagnostic medical center

Abstract Background Growth hormone (GH) stimulation tests are used to diagnose short stature in children and to assess hypothalamic-pituitary axis in adults. The most frequently stimulation tests are: oral clonidine (CLO), insulin-induced hypoglycemia (ITT), glucagon (GLU) and exercise (EXE). Well-known side effects are hypotension, nausea and vomiting. The aim of this study was to evaluate side effects and intercurrences observed during the performance of GH stimulation tests and to identify their possible predisposing factors. Methods From April/2022 to May/2023, in a large private laboratory located in 8 different sites, 3,006 GH stimulation tests were performed, with 266 patients with two or more GH stimulation tests. Results Considering only patients aged < 18 years (95% of the tests), the mean age was 10.3 ± 2.7 years (median 10.6 years), with 62.5% being male. GH stimulation test was distributed as follows: 64% CLO, 27.6% ITT, 7% GLU and 1.4% EXE. Patients with a history of asthma, allergies, seizure and heart disease were reported in 3%, 1.7%, 0.9% and 0.6%, respectively. More than 2 punctures for venous access were necessary in 9.3% of the cases, particularly in CLO test. The age of patients submitted to GLU was significantly lower compared to CLO and ITT (9.5 ± 3.3 years vs 10.3 ± 2.7 years and 10.6 ± 2.6 years, p < 0.001). Side effects were noted in only 5.1% of the total tests (145/2,863 tests), most frequent in the GLU (50/197 tests, 25%) and none observed in the EXE. There was no correlation of reported side effects with age and weight. As expected, hypotension was more frequent in CLO (27%), not associated with the oral clonidine administered dose (0.1 or 0.150 mg/SC). Nausea and vomiting occurred in 23% of the GLU tests. Symptomatic hypoglycemia that needed glucose administration (oral or parenteral) occurred in 8% of the ITT. Cough was observed in 6 patients during CLO, with no previous history of asthma or allergies. There were no occurrences that hospital transfer was need. Conclusions GH stimulation tests are safe and rarely cause serious side effects, certainly due to the presence of a prepared team for promptly support.