Six-sigma and quality planning of TORCH tests in the Peruvian population: a single-center cross-sectional study

Abstract Objective To ensure the health of newborns, it is necessary to perform high-quality diagnostic tests. The TORCH panel is a set of tests that identifies infectious pathogens such as Toxoplasma (Toxo) and Cytomegalovirus (CMV) that are common in low-setting populations. We performed TORCH panel quality planning using six sigma in a reference laboratory at Peru. Results This was a cross-sectional study. TORCH tests include Toxo, Rubella, CMV, and Herpes. We processed all samples by fourth-generation ELISA on the GEMINI XCR200 analyzer (Diatron, Budapest, Hungary). We obtained the imprecision from the annual data of the external quality assessment plan and we used the CLSI EP12-A3 guideline. In a total of 44,788 analyses, the average imprecision was 3.69 ± 1.47%, and CMV had lower imprecision (2.3 and 2.6% for IgM and IgG, respectively). Quality planning of the TORCH panel allowed estimating the sigma value that ranged from 4 to 10 (average 7 ± 2 sigma), where rubella had the highest values (10 for IgM and 8 for IgG) while HSV2 had the lowest values (4 for IgM and 5 for IgG). Our results suggest the optimal performance of half of the markers including Toxoplasma, Rubella, and CMV in the Peruvian population.

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Performance evaluation of tuberculosis smear microscopists working at rechecking laboratories in Ethiopia

African Journal of Laboratory Medicine ◽

10.4102/ajlm.v6i1.590 ◽

2017 ◽

Vol 6 (1) ◽

Author(s):

Habtamu Asrat ◽

Abebaw Kebede ◽

Abnet Abebe ◽

Abyot Meaza ◽

Getinet Hailu ◽

...

Keyword(s):

Quality Assessment ◽

Work Experience ◽

External Quality Assessment ◽

Cross Sectional Study ◽

Smear Microscopy ◽

Reference Laboratory ◽

External Quality ◽

Tuberculosis Case ◽

Cross Sectional ◽

National Tuberculosis

Background: Tuberculosis is an infectious disease caused by the bacillus Mycobacterium tuberculosis. According to the Ethiopian Federal Ministry of Health’s 2013–2014 report, the tuberculosis case detection rate was 53.7%, which was below the target of 81% set for that year.Objective: This study assessed the performance of tuberculosis smear microscopists at external quality assessment rechecking laboratories in Ethiopia.Methods: A cross-sectional study was conducted at 81 laboratories from April to July 2015. Panel slides were prepared and validated at the National Tuberculosis Reference Laboratory. The validated panel slides were used to evaluate the performance of microscopists at these laboratories compared with readers from the reference laboratory.Results: A total of 389 external quality assessment rechecking laboratory microscopists participated in the study, of which 268 (68.9%) worked at hospitals, 241 (62%) had more than five years of work experience, 201 (51.7%) held Bachelors degrees, and 319 (82%) reported tuberculosis smear microscopy training. Overall, 324 (83.3%) participants scored ≥ 80%. Sensitivity for detecting tuberculosis bacilli was 84.5% and specificity was 93.1%. The overall percent agreement between participants and reference readers was 87.1 (kappa=0.72). All 10 slides were correctly read (i.e., scored 100%) by 80 (20.6%) participants, 156 (40.1%) scored 90% – 95%, 88 (22.6%) scored 80% – 85% and 65 (16.7%) scored below 80%. There were 806 (20.7%) total errors, with 143 (3.7%) major and 663 (17%) minor errors.Conclusion: The overall performance of participants in reading the slides showed good agreement with the reference readers. Most errors were minor, and the ability to detect tuberculosis bacilli can be improved through building the capacity of professionals.

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Status of Thyroid Disorder among the Thyroid Function Test Samples Received in a Laboratory among Postmenopausal Women: A Descriptive Cross-sectional Study

Journal of Nepal Medical Association ◽

10.31729/jnma.6191 ◽

2021 ◽

Vol 59 (234) ◽

Author(s):

Manoranjan Shrestha ◽

Reshmi Shrestha

Keyword(s):

Postmenopausal Women ◽

Thyroid Function ◽

Subclinical Hypothyroidism ◽

Thyroid Dysfunction ◽

Thyroid Function Test ◽

Cross Sectional Study ◽

Reference Laboratory ◽

Sectional Study ◽

Cross Sectional ◽

Function Test

Introduction: Thyroid dysfunction prevalence is high in females worldwide which increases with age. Postmenopausal and elderly women are particularly at risk of developing comorbidities and mortality related to thyroid dysfunction. We aimed to study the prevalence of thyroid dysfunction in postmenopausal women in the National Reference Laboratory of Nepal. Methods: A descriptive cross-sectional study was conducted in National Reference Laboratory from January 2019 to June 2019 including postmenopausal females, ≥49 years. The database of thyroid function test result was used for statistical analysis and proportion of thyroid dysfunction was calculated. The data was collected after approval from the institutional review committee. Statistical Package for Social Sciences version 21 was used to study descriptive data. Results: Out of a total of 160 postmenopausal females with thyroid function tests, 71 (44.4%) had thyroid dysfunction. Subclinical hypothyroidism was the frequently occurring thyroid dysfunction 51 (32%) followed by subclinical hyperthyroidism 13 (8%), hypothyroidism 3 (2%) and hyperthyroidism 3 (2%). In our study population, thyroid dysfunction peaked at 49 to 58 years of age interval 53 (33.1%) and subclinical hypothyroidism was the most frequent form 38 (23.7%). Conclusions: Subclinical hypothyroidism was the common thyroid dysfunction in postmenopausal age which peaked at 49 to 58 years of age group. Early postmenopausal females are predisposed to increased risk of comorbidities (cardiovascular disease, osteoporosis with high fracture, depression) which could be exacerbated with thyroid dysfunction; therefore awareness of thyroid dysfunction prevalence and thyroid screening for early management seems appropriate in Nepalese postmenopausal women.

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A Cross-Sectional Study to Assess Capacity of Health Facility Laboratories in Zone One of Afar Regional State, Ethiopia

Journal of Tropical Medicine ◽

10.1155/2018/9274127 ◽

2018 ◽

Vol 2018 ◽

pp. 1-6

Author(s):

Chalachew Genet Akal ◽

Tesfaye Andualem

Keyword(s):

Quality Control ◽

Cross Sectional Study ◽

Control Measures ◽

Internal Quality Control ◽

Internal Quality ◽

Sectional Study ◽

Medical Decisions ◽

External Quality ◽

Cross Sectional ◽

Service Training

Role of laboratory service in patient care is well recognized in developed compared to developing countries like Ethiopia where most medical decisions are based on clinical judgment. Laboratory based medical decisions save life and resources. Thus, health facilities (HFs) having capacitated laboratories provide better health care service. Thus, this study assessed capacity of laboratories found in all nine HFs in zone one of Afar region, Ethiopia. Cross-sectional study was conducted from January to May 2015. Data were collected using questioner from medical laboratory professionals (MLPs) and using cheek list from laboratory registration books. Collected data was analyzed using SPSS. Availability of laboratory related national guidelines and standard operating procedure varies among HFs studied. In 42 selected laboratory equipment and materials assessed, their availability shows variations among HFs from 13 (30.2%) to 32 (74.4%). Among different laboratory tests recommended to be performed at health center (HC) level by World Health Organization (WHO), six tests were not performed in all HC laboratories. Moreover, 11 (31.4%) MLPs received in-service training in the past one year. Internal quality control measures were done in 3 (33.3%) laboratories. However, all laboratories were involved in external quality assurance with varied schedules. Specimens after testing and specimen with prolonged transit time were discarded using standard rejection criteria in 8 (88.9%) and 3 (33.3) laboratories, respectively. Study showed that laboratories assessed have good capacities in involving external quality assurance and having proper laboratory test request format. But capacity of laboratories assessed is limited and unsatisfactory in number of laboratory tests performed at HC laboratories, in internal quality control measure implementation, and in getting up-to-date in-service training to staff. Thus, to enhance capacity of laboratories in HC, responsible bodies shall avail basic laboratory materials and equipment, make fair distribution of MLPs, provide up-to-date training, and implement internal quality control measures in laboratories.

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Performance assessment of four HIV self-test devices in South Africa: A cross-sectional study

South African Journal of Science ◽

10.17159/sajs.2021/7738 ◽

2021 ◽

Vol 117 (1/2) ◽

Author(s):

Mohammed Majam ◽

Alex E. Fischer ◽

Naleni Rhagnath ◽

Vanessa Msolomba ◽

Willem D.F. Venter ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Cross Sectional Study ◽

World Health ◽

Fourth Generation ◽

Sectional Study ◽

Cross Sectional ◽

Health Device ◽

And Performance ◽

Health Organization ◽

Index Sensitivity

HIV self-testing (HIVST) has been introduced to supplement existing HIV testing methods to increase the number of people knowing their HIV status. Various HIVST kits have been developed; however, in many countries, their entry into the market is contingent on either being listed as World Health Organization (WHO) prequalified diagnostics/products or being approved by that country’s health device regulator or both. In this cross-sectional study, we evaluated the usability, sensitivity and specificity of HIVSTs, as directed by the WHO prequalification literature. A boxed, sealed HIVST kit was provided to enrolled lay users with no further instruction, who then performed the test under observation. For each HIVST, a product-specific semi-structured checklist was used to calculate a usability index, while the sensitivity and specificity of each HIVST were calculated by comparing the HIVST results to the ‘gold standard’ – fourth-generation ELISA laboratory blood test. The average usability index was 97.1% (95.9–97.8%), while the average sensitivity and specificity were 98.2% (96.8–99.3%) and 99.8% (99.4–100.0%), respectively. We also diagnosed 507 (15.1%) HIV-positive participants from the general population. The average usability index, sensitivity and specificity were all comparatively high, and these results corroborate previous usability and performance studies from other regions. These results suggest HIVSTs are appropriate for the South African market and can assist manufacturers with readying their devices for final WHO prequalification evaluation.

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Screening for Human Immunodeficiency Virus Infection by Use of a Fourth-Generation Antigen/Antibody Assay and Dried Blood Spots: In-Depth Analysis of Sensitivity and Performance Assessment in a Cross-Sectional Study

Journal of Clinical Microbiology ◽

10.1128/jcm.01645-19 ◽

2019 ◽

Vol 58 (1) ◽

Cited By ~ 1

Author(s):

Karl Stefic ◽

Jerome Guinard ◽

Gilles Peytavin ◽

Leïla Saboni ◽

Cécile Sommen ◽

...

Keyword(s):

Real Life ◽

Dried Blood Spots ◽

Cross Sectional Study ◽

Fourth Generation ◽

High Risk Population ◽

Sectional Study ◽

Cross Sectional ◽

Blood Spots ◽

Depth Analysis ◽

Antigen Antibody

ABSTRACT We evaluated the performance of a fourth-generation antigen/antibody (Ag/Ab) assay for detecting HIV-1 infection on dried blood spots (DBS) both in a conventional laboratory environment and in an epidemiological survey corresponding to a real-life situation. Although a 2-log loss of sensitivity compared to that with plasma was observed when using DBS in an analytical analysis, the median delay of positivity between DBS and crude serum during the early phase postacute infection was 7 days. The performance of the fourth-generation assay on DBS was approximately similar to that of a third-generation (antibody only) assay using crude serum samples. Among 2,646 participants of a cross-sectional study in a population of men having sex with men, 428 DBS were found reactive, but negative results were obtained from 5 DBS collected from individuals who self-reported a positive HIV status, confirmed by detection of antiretroviral (ARV) drugs in their DBS. The data generated allowed us to estimate a sensitivity of 98.8% of the fourth-generation assay/DBS strategy in a high-risk population, even including a broad majority of individuals on ARV treatment among those HIV positive. Our study brings additional proofs that DBS testing using a fourth-generation immunoassay is a reliable strategy able to provide alternative approaches for both individual HIV testing and surveillance of various populations.

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Characterization of mycobacterium isolates from pulmomary tuberculosis suspected cases visiting Tuberculosis Reference Laboratory at Ethiopian Health and Nutrition Research Institute, Addis Ababa Ethiopia: a cross sectional study

Asian Pacific Journal of Tropical Medicine ◽

10.1016/s1995-7645(14)60184-x ◽

2015 ◽

Vol 8 (1) ◽

pp. 35-40 ◽

Cited By ~ 4

Author(s):

Biniam Mathewos ◽

Nigatu Kebede ◽

Tesfu Kassa ◽

Adane Mihret ◽

Muluwork Getahun

Keyword(s):

Addis Ababa ◽

Cross Sectional Study ◽

Reference Laboratory ◽

Sectional Study ◽

Cross Sectional ◽

Health And Nutrition ◽

Nutrition Research ◽

Research Institute

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Patients' understanding of words used to describe lumps: a cross-sectional study

The Journal of Laryngology & Otology ◽

10.1017/s0022215105006481 ◽

2005 ◽

pp. 1

Author(s):

Neil K Chadha ◽

Costa Repanos

Keyword(s):

Cross Sectional Study ◽

Sectional Study ◽

Cross Sectional

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Does a Graduate Course in Fluency Disorders Make a Difference?

Perspectives on Fluency and Fluency Disorders ◽

10.1044/ffd20.1.10 ◽

2010 ◽

Vol 20 (1) ◽

pp. 10-14 ◽

Cited By ~ 2

Author(s):

Evelyn R. Klein ◽

Barbara J. Amster

Keyword(s):

Undergraduate Students ◽

Graduate Programs ◽

The United States ◽

Cross Sectional Study ◽

Sectional Study ◽

Graduate Course ◽

Cross Sectional ◽

Fluency Disorders ◽

Introductory Course ◽

Communicative Disorders

Abstract A study by Yaruss and Quesal (2002), based on responses from 134 of 239 ASHA accredited graduate programs, indicated that approximately 25% of graduate programs in the United States allow students to earn their degree without having coursework in fluency disorders and 66% of programs allow students to graduate without clinical experience treating people who stutter (PWS). It is not surprising that many clinicians report discomfort in treating PWS. This cross-sectional study compares differences in beliefs about the cause of stuttering between freshman undergraduate students enrolled in an introductory course in communicative disorders and graduate students enrolled and in the final weeks of a graduate course in fluency disorders.

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