Interlaboratory reproducibility of atypical glandular cells of undetermined significance: a national survey

OBJECTIVE: The aim of this study was to evaluate the inter-laboratory reproducibility for atypical glandular cells (AGC) (The Bethesda System (TBS) 2001) of the laboratories involved in the screening programmes in Italy. METHODS: A set of 35 selected slides were circulated among 167 laboratories involved in local population-based cervical screening programmes. Each laboratory provided one single diagnosis per smear. The smears were read blind to the original diagnosis and to the diagnoses provided by other laboratories. A 'majority' diagnosis was defined for each case and assumed as the reference standard. The diagnosis provided from each laboratory was compared with the majority diagnosis. RESULTS: According to the majority report the 35 slides in the set were classified as negative in nine cases, AGC in eight, adenocarcinoma in eight, and squamous lesion or squamous + glandular lesion in 10. The crude agreement between all pairs of laboratories was 49.43%. K-values were 0.46, 0.21, 0.34, 0.36 and 0.32 for negative, AGC/AIS (adenocarcinoma in situ of endocervix), AdenoCa, Sq/Sq + Gl and all reporting categories respectively. Concordance according to overall K was moderate to substantial in 77% of the participating laboratories. CONCLUSIONS: The present study shows that the AGC category is not easily reproducible. The data confirmed the importance, in a screening scenario, of AGC/AIS diagnoses, but also presented difficulties in differentiating between the two diagnoses. In addition to the results obtained from the circulation of the slides, laboratories which had annually a low number of cervical smears were able to gain experience focused on particular morphological pictures.     

Introduction of the Bethesda System to Mainland China with a Web-based tutorial

OBJECTIVE: To validate the use of a Web-based tutorial to introduce the Bethesda System (TBS) to Mainland Chinese laboratories. STUDY DESIGN: Digitized color images of the diagnostic features in 20 Pap smears were displayed on a Web page. Participants were asked to give each smear a diagnosis using the reporting nomenclature employed in their laboratory or one that was familiar to them. This was followed by teaching images of each smear accompanied by text in English and Chinese that highlighted important features for making a diagnosis using TBS. Participants then reviewed the 20 original Pap smears and rendered a diagnosis using TBS. RESULTS: Pathologists and cytotechnologists at 17 laboratories located in 10 cities completed the exercise. The average diagnostic accuracy for the 20 Pap smears before and after the tutorial was 76% and 88%, respectively. CONCLUSION: Web-based tutorials can be used for disseminating cytologic information to widely dispersed laboratories in China and help enhance the practice of cytology, currently an underutilized diagnostic technique. However, such difficulties as lack of Internet connections in the laboratory, outdated computers and a lack of interest in cytology need to be overcome to ensure success.     

Quality assurance of canine vaginal cytology: A preliminary study

Regulatory controls of quality assurance in veterinary laboratories are less common than in human reproduction laboratories and the intra- and inter-technician variation in the assessment of canine vaginal cytology has not been reported. This study was designed to determine whether variation in classification of vaginal epithelial cells and interpretation of vaginal cytology smears existed within and between technicians in a canine reproductive laboratory.Sixteen vaginal cytology smears representing different known stages of the oestrous cycle were examined twice by one experienced technician and three inexperienced technicians in a blinded random order study design. Seven assessments were made; counting and classifying one hundred vaginal epithelial cells into four morphological classifications and assessment of three cellular categories. Technicians also interpreted their results and reported the stage of the cycle they thought each slide represented. In addition, selected samples were sent to four external commercial laboratories for interpretation.For the experienced technician, intra-technician variation was low for the morphological classifications and cellular assessments (r = 0.69-0.95). There was more intra-technician variation between results from Examination One and Examination Two for the inexperienced technicians (r = 0.53-0.92 where correlations were found). When inexperienced technicians' results were compared to results from the experienced technician, the inter-technician variation was low; results were correlated for 17 of the 21 observations (four morphological classifications and three cellular assessments across the three technicians) (r = 0.38-0.87). When technician interpretations of stage of the oestrous cycle were compared to the known stage of the cycle for each smear, the experienced technician correctly interpreted 19 of the 32 smears, whilst the three inexperienced technicians correctly interpreted 14, 16, and 18 of the 32 smears. The interpretation of vaginal smears by external laboratories was varied and sometimes inconclusive; 50% of laboratories incorrectly identified metoestrus smears as proestrus and 25% of the laboratories incorrectly identified an oestrus smear as proestrus.The results of this study are highly important for clinicians undertaking canine reproductive assessments since they demonstrate the potential for variability of results. While the greatest precision was found when vaginal smears were examined by an experienced technician (who, on a daily basis, examines many smears), more variability in both the reporting of different cell types and interpretation of the smears was observed by inexperienced technicians and when samples were sent to external commercial laboratories. These findings suggest that suitable quality control programmes should be implemented for laboratories that are undertaking routine assessments of canine reproductive function.     

Performance of the DNA-Citoliq liquid-based cytology system compared with conventional smears

OBJECTIVE: To evaluate the performance of a new, manual, simplified liquid-based system, DNA-Citoliq (Digene Brasil), employed under routine conditions as compared to conventional smears collected from six collaborating private laboratories. METHODS: A panel of cytopathologists, who served as the gold standard diagnosis, adjudicated discordant opinions. RESULTS: Of 3206 pairs of slides considered valid for comparison, there were 3008 in full agreement (93.8%), 112 (3.5%) with one diagnostic category discrepancies, and 86 (2.7%) discordant cases. Among the 288 borderline+ by either method, DNA-Citoliq detected abnormalities in 243 (84.4%), and conventional smears (CS) detected abnormalities in 178 (61.8%) (McNemar test, P < 0.000), a 36.5% increased detection of borderline+ cases. CONCLUSIONS: For mild dyskaryosis, DNA-Citoliq detected 176 cases and CS 125 cases (McNemar test, P < 0.000); and for moderate+severe dyskaryosis 66 versus 32 cases respectively (McNemar test, P < 0.000).     

Improving the NHS cervical screening laboratory performance indicators by making allowance for population age, risk and screening interval

OBJECTIVE: One of the key performance measures in the monitoring of the NHS cervical screening programme is the targeting of laboratories with very high or low percentages (outside the 10th-90th percentile) of adequate smears that have moderate dyskaryosis or worse. These laboratories are assumed to include those laboratories that may have extremes of sensitivity and specificity. A clear limitation with this methodology is that laboratories do not examine smears from women with the same underlying risk, age distribution or screening interval and adjustment for these factors should considerably improve the method. METHODS: This paper describes a method that allows for these confounding variables and a new age-risk-interval adjusted moderate dyskaryosis or worse rate (ARI-adjusted mod+ rate) can be calculated. The adjusted rate is the rate of moderate or worse dyskaryotic smears that the laboratory would have detected had it been screening women with an English 'average' age-risk-interval. All laboratories can therefore be compared using this method. RESULTS: The methodology is illustrated using data from the NHSCSP South West Region. The particularly low percentage of moderate or worse smears detected by one or two laboratories can be shown to be due to a local screened population with a very low risk because of a high mean age, relatively short screening interval and census variables associated with a low risk, rather than any under-calling by the associated laboratories. CONCLUSIONS: The ARI-adjusted mod+ rate requires to be calculated for all laboratories in England if it is to be used as a primary performance indicator. Alternatively, it can be used to further examine laboratories that are deemed to be outliers using the current methodology.     

Reliability and accuracy of reporting cervical intraepithelial neoplasia (CIN) in 15 laboratories throughout Italy: phase 1 of a national programme of external quality control in cervical screening

This paper reports results of a first phase of a pilot study to assess and improve quality of diagnoses in cervical cytological laboratories located throughout Italy. It represents the first phase of an External Quality Assurance programme (EQA). In the first phase, two sets of cervical smears representing a range of diagnoses were circulated among participating laboratories. Responses were recorded on a standardized form. Participants were asked to assess the adequacy of the smear and formulate a diagnosis. They were also asked to recommend management of the patient on the basis of the smear report and judge the degree of diagnostic difficulty of each slide. Crude index of agreement, unweighted and weighted kappas, diagnostic specific kappas, sensitivity and specificity as well as clinical indices of variability were calculated. In the second phase, two additional sets of slides were circulated after discussion of the first phase. There was striking variability between laboratories, both in terms of diagnoses offered and recommendations for management on individual slides. Assessment of the degree of difficulty of each slide was also very variable. Discrimination between CINII and CINIII was poor, confirming the choice of merging these two categories in the Bethesda classification. However, discrimination between CINI and CINII was also unsatisfactory. The results were discussed in workshops and it was possible to reach a consensus diagnosis in 35 of 40 smears. This study confirms the need for external quality control programmes.     

The effect of nonscreening smears on screening smear results: a statistical analysis with its implications for the NHS cervical screening programme

This is a statistical analysis of individual NHS Cervical Screening Programme laboratories screening smear 'pick-up' rates (defined here as percentage low grade and percentage high grade of total adequate smears for ages 20-64 years derived from general practitioners and community clinics) in relation to their nonscreening smear workload proportion (here defined as percentage nonscreening smears of total laboratory workload from all sources for all ages). This was achieved by the use of three one way ANOVA models in order to receive a complete overview of the results. The models were applied to the following: (1) Laboratories with a total workload of less than 15000 general practitioner (GP) and community clinic smears; (2) laboratories with a total workload of greater than 15000 GP and community smears and; (3) all laboratories (i.e. a combination of 1 and 2). The 'test' groups within each of these models comprised three subgroups based on the percentage of laboratory workload that consisted of smears from a nonscreening source. This figure ranged from 2.8% to 82.6%. The subgroups were divided so as to contain approximately the same number of laboratories in each one (172 laboratories in total, 42 with workload < 15000 and 130 with > 15000). The results show that laboratories high and low grade pick-up rates have a positively correlated but variable relationship with the proportion of their workload that consists of nonscreening smears. The results show significance overall at the 5% level for high grade and the 10% level for low grade (high grade at P = 0.045 and low grade at P = 0.071). Significance for laboratories viewing less than 15000 screening smears at the 1% level (high grade P = 0.006 and low grade P = 0.005). They show no significance, however, for laboratories viewing more than 15000 screening smears (high grade P = 0.457 and low grade P = 0.622). There is an intriguing possibility that a greater exposure to abnormal smears results in a greater tendency to detect them. The current data provides no evidence to support the NHS Executive's use of 15000 as a designated figure when quality monitoring and service provision becomes a specific issue. The closure or amalgamation of laboratories with workloads less than this would appear to have no scientific evidence base.     

The Quality of Sputum Smear Microscopy in Public-Private Mix Directly Observed Treatment Laboratories in West Amhara Region,Ethiopia

Ethiopia adopted Public-Private Mix Directly Observed Treatment Short Course Chemotherapy (PPM-DOTS) strategy for tuberculosis (TB) control program. Quality of sputum smear microscopy has paramount importance for tuberculosis control program in resource-poor countries like Ethiopia. A cross-sectional study was conducted to assess the quality of sputum smear microscopy in 37 Public-Private Mix laboratories in West Amhara, Ethiopia. The three external quality assessment methods (onsite evaluation, panel testing and blind rechecking) were employed. Onsite assessment revealed that 67.6% of PPM-DOTS laboratories were below the standard physical space (5 X 6) m². The average monthly workload per laboratory technician was 19.5 (SD±2.9) slides with 12.8% positivity rate. The quality of Acid Fast Bacilli (AFB) staining reagents was sub-standard. The overall agreement for blind rechecking of 1,123 AFB slides was 99.4% (Kappa = 0.97). Reading of 370 AFB panel slides showed 3.5% false reading (Kappa = 0.92). Moreover, the consistency of reading scanty bacilli slides was lower (93%) compared to 1+, 2+ and 3+ bacilli. Based on blind rechecking and panel testing results, PPM-DOTS site laboratories showed good agreement with the reference laboratory. Physical space and qualities of AFB reagents would be areas of intervention to sustain the quality of sputum smear microscopy. Therefore, regular external quality assessment and provision of basic laboratory supplies for TB diagnosis would be the way forward to improve the quality of sputum smear microscopy services in PPM-DOTS laboratories.     

New statistical software for intralaboratory and interlaboratory quality control in clinical cytology. Validation in a simulation study on clinical samples

OBJECTIVE: To design a statistical software package to provide automated calculations of normal and weighted and 3 indices. STUDY DESIGN: Prompted by the lack of commonly available software to compute weighted kappa and the nonproportionate workload needed to calculate our 3 variability indices manually, the new statistical software package was designed. To demonstrate the performance of the new CONQUISTADOR software, a simulation study (both intralaboratory and interlaboratory) was designed using 5,000 clinical samples randomly selected from a data file of > or = 200,000 conventional Pap smears and programmed to become "analyzed" by 12 cytologists in 5 imaginary laboratories. RESULTS: A representative set of both complete and partial outputs provided by the software, in Excel format (Microsoft, Redmond, Washington, U.S.A.) are shown to illustrate the different functions of the program. In the interlaboratory mode, the software calculates accuracy indicators (sensitivity, specificity, positive and negative predictive value, and their 95% CI), which are not common features of regular statistical packages; kappa and weighted kappa; and their 95% CI (comparison of single laboratories to all laboratories and pairwise comparisons between single laboratories). The 3 diagnostic variability indices can be computed separately for all samples or for only the positive samples. In the intralaboratory mode, the software calculates the same indices for individual cytologists. CONCLUSION: The CONQUISTADOR statistical package has properties that are useful in monitoring cytologic laboratory quality in both intralaboratory and interlaboratory settings. The software will be distributed by the National Institute of Health, Rome, for the delivery costs only.     

Interlaboratory reproducibility of atypical squamous cells of undetermined significance report: a national survey

The study was aimed at assessing interlaboratory reproducibility in the reporting of cervical smears in the atypical squamous cells of undetermined significance (ASCUS) category. A set of 50 selected slides circulated among 89 laboratories, currently involved in population-based screening programmes for cervical cancer, which provided a diagnostic report according to four main reporting categories based on the 1991 Bethesda system. Interlaboratory agreement was determined according to kappa (K) statistics: overall and weighted K values were determined for each laboratory and for single reporting categories. The results showed a very low reproducibility for the ASCUS category. This finding supports the Bethesda system 1991 recommendation to limit the use of this reporting category and suggests that the clinical response to ASCUS reports should be decided locally, based on the observed positive predictive value for cervical intraepithelial neoplasia 2 or more severe lesions.     

Species-specific immunocytochemical localization of Mycobacterium tuberculosis complex in fine needle aspirates of tuberculous lymphadenitis using antibody to 38 kDa immunodominant protein antigen

OBJECTIVE: To examine immunocytochemical localization of Mycobacterium tuberculosis (MTB) complex antigen in fine needle aspiration (FNA) smears of tuberculous lymphadenitis (TBLN) using species-specific monoclonal antibody MTSS to 38-kDa immnunodominant protein antigen as a diagnostic adjunct to conventional cytomorphology and its advantage over Ziehl-Neelsen (ZN) microscopy. Study Design FNA smears from 340 cases-174 TBLN; 34 negative controls from nontuberculous, positive controls of 13 known acid-fast bacilli (AFB)-positive sputum smears; 50 blind controls; and 69 other controls (smears from stock cultures of bacterial, atypical mycobacteria and fungal species) were subjected to ZN and immunocytochemical staining using MTSS by the streptavidin-biotin method. RESULTS: Immunocytochemical staining was positive in 59 of 61 (96.7%) archival and 110 of 113 (97.3%) fresh FNA smears; ZN positivity for AFB was observed in 27 of 61 (44.2%) archival and 48 of 113 (42.4%) fresh FNA smears of TBLN. CONCLUSION: The immunostaining using MTSS showed a definite advantage over conventional ZN staining for detection and specific diagnosis of TBLN in FNA smears with 0% false positive results. Immunostaining of cytosmears with species specific antibody to MTB would prove to be a good diagnostic adjunct to morphologic diagnosis.     

Performance of ACMG-AMP Variant-Interpretation Guidelines among Nine Laboratories in the Clinical Sequencing Exploratory Research Consortium

Evaluating the pathogenicity of a variant is challenging given the plethora of types of genetic evidence that laboratories consider. Deciding how to weigh each type of evidence is difficult, and standards have been needed. In 2015, the American College of Medical Genetics and Genomics (ACMG) and the Association for Molecular Pathology (AMP) published guidelines for the assessment of variants in genes associated with Mendelian diseases. Nine molecular diagnostic laboratories involved in the Clinical Sequencing Exploratory Research (CSER) consortium piloted these guidelines on 99 variants spanning all categories (pathogenic, likely pathogenic, uncertain significance, likely benign, and benign). Nine variants were distributed to all laboratories, and the remaining 90 were evaluated by three laboratories. The laboratories classified each variant by using both the laboratory’s own method and the ACMG-AMP criteria. The agreement between the two methods used within laboratories was high (K-alpha = 0.91) with 79% concordance. However, there was only 34% concordance for either classification system across laboratories. After consensus discussions and detailed review of the ACMG-AMP criteria, concordance increased to 71%. Causes of initial discordance in ACMG-AMP classifications were identified, and recommendations on clarification and increased specification of the ACMG-AMP criteria were made. In summary, although an initial pilot of the ACMG-AMP guidelines did not lead to increased concordance in variant interpretation, comparing variant interpretations to identify differences and having a common framework to facilitate resolution of those differences were beneficial for improving agreement, allowing iterative movement toward increased reporting consistency for variants in genes associated with monogenic disease.     

Optimizing specimen collection and laboratory procedures reduces the non‐diagnostic rate for endoscopic ultrasound‐guided fine‐needle aspiration of solid lesions of the pancreas

Objectives: Endoscopic ultrasound‐guided fine‐needle aspiration (EUS‐FNA) is a routine technique to assess solid pancreatic lesions. The aim of this study was to analyse the effect of optimizing laboratory procedures for specimen preparation on the rate and accuracy of the procedure. Methods: All EUS‐FNAs of solid pancreatic lesions performed during the year 2000 (Period 1) and from May 2003 to May 2004 (Period 2) were analysed. During Period 1, one experienced gastroenterologist performed all EUS‐FNAs, making direct smears and retrieving small fragments if present on the smear for histology. In Period 2, two endoscopists performed the EUS‐FNAs and all the material was emptied into a vial containing a fixative. Slide preparation was carried out in the pathology laboratory: one slide was processed using cytocentrifugation and cell blocks were made from left‐over material. Neither period utilized rapid on‐site evaluation. Results: During the two periods, 67 and 102 FNAs were analysed and showed significantly different (P < 0.001) non‐diagnostic rates of 22.8% and 4.2%, respectively. The increased diagnostic yield can be explained by the modified laboratory procedures and to a lesser extent by the increased experience of the gastroenterologists. Sensitivity, specificity, PPV, NPV and accuracy in the second time period were, respectively, 90.6%, 100%, 100%, 81.8% and 93.4%, not significantly different from the first time period. Conclusion: This study shows that accurate EUS‐FNA results may be obtained with a low non‐diagnostic rate comparable to those reported for rapid on‐site evaluation by optimizing laboratory specimen processing in a setting of solid pancreatic lesions.     

Cervical cytology quality assurance in Washington State.

The objectives of this study were to establish a profile of cervical cytology laboratories in Washington State, identify quality assurance problems amenable to correction through education or legislation, and describe differences between large and small cytology laboratories. All 43 Washington laboratories that perform cervical cytology were surveyed by mail during 1989. Completed surveys were returned by 37 (86%) of the laboratories. Nearly half (43%) of the respondents reported processing less than 10,000 Papanicolaou smears annually. Only one-third (35%) of the respondents reported participating in relevant proficiency programs. A proportion of smaller cytology laboratories were compensating their cytotechnologists on the basis of the number of slides read and allowing Papanicolaou smears to be read outside the confines of the laboratory. The results of this study suggest that cytotechnologists in some larger Washington laboratories have been exceeding work load limits recommended by professional associations. Recent legislation includes regulations that address cervical cytology quality assurance. However, continued efforts will need to be made to encourage voluntary adoption of quality control measures not addressed by this legislation.     

Should the laboratory assess the sampling adequacy of cervical smears?

Should the laboratory assess the sampling adequacy of cervical smears? The results of a questionnaire answered by 14 out of the 18 NHS laboratories in Scotland reporting cervical smears showed that, since the publication of Guidelines for Judging the Adequacy of a Cervical Smear, by the British Society for Clinical Cytology (BSCC), rates of unsatisfactory smears had risen from a mean of 3.3% to 6.5%, with some laboratories reporting rates of over 10%. Four laboratories followed the guidelines closely in requiring the presence of two indicators of sampling of the transformation zone, i.e. endocervical cells, metaplastic cells or endocervical mucus. Seven laboratories required one indicator either in all smears or in a subset, whilst three did not require any indicator at all. The laboratories observing the guidelines closely had a higher mean unsatisfactory rate than those partially observing them. The main impediment to the full implementation of the BSCC guidelines appeared to be fear of an unmanageably high unsatisfactory smear rate. The accuracy of the assessment of adequacy is questioned, as is the cost effectiveness of doing so.     

Identification of bacterial strains by laboratories participating in the Deutsches Krebsforschungszentrum quality assurance programme

The quality assurance programme (QAP) of the Deutsches Krebsforschungszentrum (DKFZ) is a proficiency testing system developed to service the laboratory animal discipline. QAP comprises the quarterly distribution of two bacterial strains originating from various species of animals for identification to the species level and antibiotic susceptibility testing. We compared identification results reported by QAP participants over the years 1996-2004 with those obtained by the Dutch Bacterial Diagnostics reference laboratory on 68 samples comprising 71 bacterial strains and a fungus. Significant differences were found in the frequency of reported and correct identifications when bacteria were assigned to different groups based on morphology by Gram stain and on origin (animal versus environmental, rodent and rabbit versus other animal species, pathogen versus non-pathogens). Rodent and rabbit pathogens yielded 73% correct identifications, and with all bacterial strains only 60% of the identifications were correct. We assume that most QAP participants were from laboratory animal diagnostic laboratories. If this is true, the capabilities of laboratories in the laboratory animal discipline to correctly identify bacterial species are well below what are considered acceptable limits for human diagnostic laboratories. The distribution of cultured bacteria circumvents the most difficult step in the microbiological monitoring of animals, namely primary culture from clinical samples. We propose to set up a QAP that comprises the distribution of specimens mimicking clinical samples normally submitted to laboratory animal diagnostic laboratories.     

Performance of a new, liquid-based cervical screening technique in the clinical setting of a large French laboratory

OBJECTIVE: To compare the performance of liquid-based cytology with the CYTO-screen System (SEROA) with that of conventional smears through a secondary analysis of a large database covering the activity of an independent French laboratory during the period 1998-2002. STUDY DESIGN: The study was performed with a retrospective, comparative, historical design on 2 subgroups of women having been screened by gynecologists who switched from conventional smears to the CYTO-screen System in the period 1998-2002. The first cohort population consisted of women who had at least 4 subsequent screening tests over the period with half conventional and half with the CYTO-screen System. A control group consisted of smears collected by gynecologists who fully maintained activity with a conventional method over the same period. The second group consisted of women who had their first screening test performed over the study period by gynecologists who modified their technique. Specimen adequacy, endocervical cell content and epithelial cell abnormality detection rates were compared between the groups. RESULTS: As compared with the conventional smear, the CYTO-screen System showed a reduction in unsatisfactory reports, especially in the second group of first-screened (0.14% versus 1.3%, P < .0001). The rate of atypical squamous cells of undetermined significance increased significantly after the switch to the CYTO-screen System (2.5% versus 1.3%, P = .004) and in the second group of first-screened women (2.05% versus 1.4%, P = .0014), with higher histologic confirmation in both situations. There was a non-significant increase in the detection rates of low and high grade squamous intraepithelial lesions after the switch to the CYTO-screen System and in the second group of first-screened women. CONCLUSION: The CYTO-screen System gives higher-quality specimens and has a higher detection rate for squamous intraepithelial lesions, but that rate was significant only for atypical squamous cells of undetermined significance.     

Utility and diagnostic accuracy of fallopian tube touch imprint cytology

OBJECTIVE: To determine the diagnostic accuracy of cytology smears in distinguishing between tube and non-tube structures. METHODS: One hundred cytology smears of fallopian tube and non-tube structures (vessels, round and ovarian ligaments) were prepared from surgically removed uterus and fallopian tube specimens and stained by the Papanicolaou method. The slides were reviewed blindly by pathologists and interpreted as tube or non-tube structures. The results were compared to the histological examination of the same specimens. FINDINGS: Results indicated an overall accuracy of 97% with a specificity of 98% and sensitivity of 96% for cytology smears, taking histology as the gold standard. Positive and negative predictive values were 96.1% and 97.9%, respectively. CONCLUSION: Cytology smears are a convenient and cost effective tool for laboratory confirmation of tubal sterilization. This method can reduce the costs of laboratory examination, especially in developing countries, where tubal sterilizations are done in large cohorts. However, histological slides remain the gold standard in cases of medicolegal problems.     

Within-laboratory and between-laboratory variability in the measurement of anti-müllerian hormone determined within an external quality assurance scheme

Ten laboratories in an external quality assurance scheme used the same assay to measure anti-müllerian hormone concentration (Beckman Coulter Gen II) and received twenty serum samples distributed over a 15 month period. The mean bias for all results was only ?0.089%, but there was large coefficient of repeatability of 38.8% (sample bias ranged from ?37.9% to +54.7%). While each laboratory showed good reproducibility, there was a wide range of average values relative to the consensus value from ?24.0% to +22.7%. This between-laboratory variability suggests clinicians should use the same laboratory to avoid problems with result interpretation.     

Tuberculosis Laboratory Diagnosis Quality Assurance among Public Health Facilities in West Amhara Region,Ethiopia

Introduction

Reliable smear microscopy is an important component of Directly Observed Treatment Scheme (DOTS) strategy for TB control program in countries with limited resources. Despite external quality assessment is established in Ethiopia, there is lower TB detection rate (48%) in Amhara region compared to the World Health Organization (WHO) estimate (70%). This highlights the quality of smear microscopy needs to be evaluated. Therefore, the aim of this study was to assess the quality of sputum smear microscopy performance among health center laboratories in West Amhara region, Ethiopia.

Materials and Methods

A cross sectional study was conducted from July 08, 2013 to July 07, 2014. Data were collected from 201 public health center laboratories using a structured questionnaire. Slides were collected based on Lot Quality Assurance Sampling (LQAS) method and rechecked blindly by trained laboratory technologists. The data were entered into EPI info V.7 and smear quality indicators and AFB results were analyzed by SPSS version 20.

Results

Among 201 laboratories enrolled in this study, 47 (23.4%) laboratories had major errors. Forty one (20.4%) laboratories had a total of 67 false negative and 29 (14.4%) laboratories had a total of 68 false positive results. Specimen quality, smear thickness and evenness were found poor in 134 (66.7%), 133 (66.2%) and 126 (62.7%) laboratories, respectively. Unavailability of microscope lens cleaning solution (AOR: 2.90; 95% CI: 1.25–6.75; P: 0.013) and dirty smears (AOR: 2.65; 95% CI: 1.14–6.18; P: 0.024) were correlated with false negative results whereas no previous EQA participation (AOR: 3.43; 95% CI: 1. 39-8.45; P: 0.007) was associated with false positive results.

Conclusion

The performance of health facilities for sputum smear microscopy was relatively poor in West Amhara region. Hence, strengthening the EQA program and technical support on sputum smear microscopy are recommended to ensure quality tuberculosis diagnostic service.