Delays in HIV-1 infant polymerase chain reaction testing may leave children without confirmed diagnoses in the Western Cape province, South Africa

Background: Early diagnosis and confirmation of HIV infection in newborns is crucial for expedited initiation of antiretroviral therapy. Confirmatory testing must be done for all children with a reactive HIV PCR result. There is no comprehensive data on confirmatory testing and HIV PCR test request rejections at National Health Laboratory Service laboratories in South Africa.Objective: This study assessed the metrics of routine infant HIV PCR testing at the Tygerberg Hospital Virology Laboratory, Cape Town, Western Cape, South Africa, including the proportion of rejected test requests, turn-around time (TAT), and rate of confirmatory testing.Methods: We retrospectively reviewed laboratory-based data on all HIV PCR tests performed on children ≤ 24 months old (n = 43346) and data on rejected HIV PCR requests (n = 1479) at the Tygerberg virology laboratory over two years (2017­2019). Data from sample collection to release of results were analysed to assess the TAT and follow-up patterns.Results: The proportion of rejected HIV PCR requests was 3.3%; 83.9% of these were rejected for various pre-analytical reasons. Most of the test results (89.2%) met the required 96-h TAT. Of the reactive initial test results, 53.5% had a follow-up sample tested, of which 93.1% were positive. Of the initial indeterminate results, 74.7% were negative on follow-up testing.Conclusion: A high proportion of HIV PCR requests were rejected for pre-analytical reasons. The high number of initial reactive tests without evidence of follow-up suggests that a shorter TAT is required to allow confirmatory testing before children are discharged.

Newly implemented community CD4 service in Tshwaragano, Northern Cape province, South Africa, positively impacts result turn-around time

Background: The Northern Cape is South Africa's largest province with an HIV prevalence of 7.1% versus a 13.5% national prevalence. CD4 testing is provided at three of five National Health Laboratory Service district laboratories, each covering a 250 km precinct radius. Districts without a local service report prolonged CD4 turn-around times (TAT).Objective: This study documented the impact of a new CD4 laboratory in Tshwaragano in the remote John Taolo Gaetsewe district of the Northern Cape, South Africa.Methods: CD4 test volumes and TAT (total, pre-analytical, analytical, and post-analytical) data for the Northern Cape province were extracted for June 2018 to October 2019. The percentage of CD4 results within the stipulated 40-h TAT cut-off and the median and 75th percentiles of all TAT parameters were calculated. Pre-implementation, samples collected at Tshwaragano were referred to Kimberley or Upington, Northern Cape, South Africa.Results: Pre-implementation, 95.4% of samples at Tshwaragano were referred to Kimberley for CD4 testing (36.3% of Kimberley's test volumes). Only 7.5% of Tshwaragano's total samples were referred post-implementation. The Tshwaragano laboratory's CD4 median total TAT decreased from 24.7 h pre-implementation to 12 h post-implementation (p = 0.003), with >95.0% of results reported within 40 h. The Kimberley laboratory workload decreased by 29.0%, and testing time significantly decreased from 10 h to 4.3 h.Conclusion: The new Tshwaragano CD4 service significantly decreased local TAT. Upgrading existing community laboratories to include CD4 testing can alleviate provincial service load and improve local access, TAT and efficiency in the centralised reference laboratory

Establishment and evaluation of an autoverification scheme for hematology analysis in cancer patients / 中华检验医学杂志

Objective:According to the characteristics and common problems of hematology analysis in cancer patients, an autoverification scheme for cancer patients was formed, and the effectiveness and efficiency of the autoverification scheme were verified.Methods:The hematology review of international consensus and ourselves were respectively combined with Chinese multicenter autoverification rules to form two autoverification schemes. 10 063 blood samples (460 cases reviewed by microscope) were selected as the establishment group. Retrospective judgment was made in the instrument middleware, and various indexes such as autoverification pass rate and missed detection rate of different schemes were compared. By analyzing the data of missed cases one by one, the autoverification rules are adjusted according to the characteristics of diagnosis and treatment of cancer patients. By analyzing the platelet count variation range within 7 days in 19 300 cases, the Delta rules of platelet count were established. The platelet count Delta rules and the adjusted autoverification rules were combined to form the autoverification rules of our hospital and then combined with our hematology review rules to form the autoverification scheme of our hospital. The establishment group and verification group (10 876 cases, including 1 740 cases of microscopic examination) of the autoverification schemes were judged. The recognition function of Ethylenediaminetetraacetic acid-dependent pseudo thrombocytopenia (EDTA-PTCP) and PLT Delta check were programmed in the laboratory information system (LIS), and other rule judgment functions are performed in middleware. After four months of clinical trial application of 61 602 specimens, the effectiveness of our autoverification scheme was comprehensively evaluated.Results:The autoverification pass rates of international hematology review rules, our review rules, and Chinese multicenter autoverification rules are 46.36%, 52.26%, and the missed detection rates are 2.02%, 1.06%, respectively. The autoverification pass rates of our hospital autoverification scheme in the establishment group and the verification group are 51.19% and 52.78%, the missed detection rates are 0% and 0.03%, and the true positive rate are 100% and 99.95%, respectively. 56.06% of cases were passed automatically during the clinical trial application, and there were no missing cases, the true positive rate is 100%. The performance of our autoverification scheme is superior to the current autoverification schemes combined with mainstream hematology review rules and autoverification rules. The median time of TAT by autoverification was shortened by 15 minutes, and the 90th percentile time was shortened by 58 minutes, which was significantly lower than that of the same period last year. The marker function of "EDTA-PTCP" identified 31 special patients and 68 samples had been analyzed in total. After correction, the median increase of PLT was 76.5×10 9/L ( Z=-7.17, P<0.001). Conclusions:This study has established an autoverification scheme that combined by rules of hematology review and autoverification rules. It is suitable for cancer patients with high pass rate and very low rate of missed detection. This autoverification scheme can ensure the accuracy of the hematology analysis of cancer patients in our hospital and improve work efficiency.

Operational analysis of the national sickle cell screening programme in the Republic of Uganda

Background: Sickle cell anaemia is a common global life-threatening haematological disorder. Most affected births occur in sub-Saharan Africa where children usually go undiagnosed and die early in life. Uganda's national sickle cell screening programme was developed in response to a 2014 sickle cell surveillance study that documented a high disease prevalence. Objective: This study describes the temporal and financial aspects of Uganda's 2014­2019 sickle cell screening programme. Methods: National sickle cell screening data from Uganda's Central Public Health Laboratories were used to calculate turn-around times (TATs) from sample collection to delivery, testing, and result reporting for blood samples collected from February 2014 to March 2019. The parameters affecting specific TATs were assessed. The exact programme expenditures were analysed to determine cost per test and per positive sickle cell disease case detected. Results: A total of 278 651 samples were analysed. The median TAT from sample collection to laboratory receipt was 8 days (interquartile range [IQR]: 6­12), receipt to testing was 3 days (IQR: 1­7), and testing to result reporting was 6 days (IQR: 3­12). Altogether, the sample continuum averaged 16 days (IQR: 11­24). Lower level healthcare facilities were associated with longer sample delivery TATs. Calendar months (January and December) and larger sample volumes impacted testing and result reporting TATs. The cost per test was $4.46 (United States dollars [USD]) and $483.74 USD per positive case detected. Conclusion: Uganda's sickle cell screening programme is efficient and cost-effective. Universal newborn screening is the best strategy for detecting sickle cell anaemia in Uganda.

Evaluation of biochemical and immunological assembly line in emergency test / 中华检验医学杂志

Objective@#To explore the application value of biochemical and immunological assembly line in emergency test by comparatively analyzing the changes in sample test process and turnaround time (TAT) in emergency test before and after installation of the assembly line.@*Methods@#A retrospective study was performed with the run data of the emergency biochemical and immunodetection project in Department of Clinical Laboratory in Tongji Hospital Affiliated to Tongji University from July to September in 2017 and from July to September in 2018. (1)The changes in sample circulation mode and test process were compared in emergency test before and after installation of the assembly line.(2)The changes in TAT of sample test and distribution of time interval in emergency laboratory report were statistically analyzed before and after installation.(3)The number of samples tested between instruments and occurrence of instrument failure were statistically compared before and after installation. (4)Biosafety risk assessment was performed on the sample test process before and after installation to analyze the effects of the assembly line installation on biosafety control in emergency test.@*Results@#(1) By applying the assembly line, the sample test process was well controlled and the workload for laboratorians was eased greatly through reduction of manual work.(2) Report TAT was remarkably shortened after installation compared to that before installation; the TAT of dry biochemistry and myocardial zymogram report in emergency test was shorted from 39 min and 48 min to 34 min and 42 min respectively, with a reduction of 12.82% an 12.50% compared to those before installation; the TAT of dry biochemistry and myocardial zymogram report in inpatient emergency was shorted from 37 min and 43 min to 29 min and 35 min respectively, with a reduction of 21.61% an 18.60% compared to those before installation; distribution of report TAT was comparatively analyzed, the percentage of reports in 0-30 min and 31-45 min increased remarkably compared to that before installation, the percentage of TAT of dry biochemistry report falling into 0-45 min increased to 74.58% and 85.66% after installation from 57.91% and 78.28% before installation, respectively in emergency and inpatient emergency. (3)For the model VITROS5600, the percentage of samples tested changed from 30.29% and 69.71% before installation to 47.63% and 52.37% after installation, respectively; for the model DXI800, the percentage of samples tested changed from 28.77% and 71.23% before installation to 53.49% and 46.51% after installation, respectively. After installation, there was a tendency of balance in the number of samples tested between instruments. Instrument failure was significantly reduced: for the model VITROS5600, the frequency of instrument failure decreased from 3.5 times a month/instrument before installation to 2 times a month/instrument after installation on average; for the model DXI800, the frequency of instrument failure decreased from 2.8 times a month/instrument before installation to 1.8 times a month/instrument after installation on average.(4) Installation of the assembly line lowered the risks biosafety events in sample test process in emergency test and the two risks of accidental contact with aerosol in sample tubes before detection and accidental contact with biological specimen due to overturning and spilling during detection were reduced from a high level before installation to a low level after installation.@*Conclusion@#In emergency test, biochemical and immunological assembly line is of certain value in process improvement, reduction of workload for laboratorians, improvement of work efficiency, TAT reduction and optimization, as well as control of biosafety conditions.

Management and practice of intra-laboratory Turn-Around-Time in emergency testing laboratory / 国际检验医学杂志

Objective To master the actual work efficiency situation of emergency inspection,analyze the existing problems,and provide objective basis for continuous improvement through the statistic analysis of intra-laboratory turn-around time (TAT) median,coincidence rate of inspection report within the specified time limit,report timeout reasons and other indexes of different items of emergency inspection group in 2015.Methods All kinds of original data from the different items of emergency inspection groupswere derived from LIS system,according to the different types of projects in different segments.Microsoft Excel2003 software was used to count the actual TAT time of various items,and function was used to calculate TAT median;The non-conformance rate (inspection report timeout rate) and coincidence rate within the prescribed time limit by inspection report were calculated,and gather the statistical analysis on the timeout reasons of daily recorded report.Results With the exception of electrochemical luminescence class,the TAT of other items decreased in different degrees of emergency inspection group in 2015 when compared with 2014.The average coincidence rate of inspection report of various items within the time limit was 94.8%,non-conformance rate of inspection report of prescribed time limit was 5.2%.The top four inspection timeout reasons of various items were more number of submitted samples(59.6%),redo the reinspection (12.4%),smear reinspection (12.0%) and equipment failure (10.0%) in turn.Conclusion The time limit of the emergency report meets the specified requirements and statistical analysis of the causes of overtime can find out the problems and take appropriate measures to provide an objective basis for continuous improvement.

A comparative study on microwave and routine tissue processing.

Aim and Objective: The present study was aimed at assessing the rapid microwave-assisted tissue processing and staining to determine if it can replace standard formalin-fixed and paraffin-embedded processing and staining technique. Materials and Methods: The study group consisted of 15 oral mucosal biopsies. The specimens were fixed in 10% formalin for 24 hours to ensure adequate fixation and their gross features were recorded, photographed, and then the specimens were cut into equal halves to be processed by both conventional and microwave histoprocessing methods and then subsequently stained with H and E by microwave and conventional methods. The stained slides in each group processed by both microwave and routine methods were randomly numbered for a blind study and circulated among six observers. All the observers were asked to grade each parameter into Excellent/Good/Average/Poor in a data sheet comprising a total of six parameters. These gradings were given a numerical value of 4, 3, 2 and 1, respectively. The parameters included in the data sheet were cellular clarity, cytoplasmic details, nuclear details, color intensity, interface of epithelium and connective tissue. Wilcoxon-matched pairs signed rank test (non-parametric) was used to calculate the test of significance (P value). Results: The total processing time involved in microwave was 42 minutes and 270 minutes for the conventional method. H and E staining in microwave took 33 minutes and 40 minutes for conventional method. Conclusions: The individual scores by different observers regarding the various parameters included in the study were statistically insignificant, the overall quality of microwave-processed and microwave-stained slides appeared slightly better than conventionally processed and stained slides.

Survey on Changes in Mycobacterial Testing Practicies in Korean Laboratories / 대한임상미생물학회지

BACKGROUND: Since 1997 in which first survey for mycobacterial practices of hospitals in Korea were carried on, changes of practice and concept in mycobacterial testing have been expected because advanced testing methods have been surged for last five-year-period. We purposed to follow-up survey to monitor practices changes, and in addition, situation of quality control. METHODS: Questionnaires was composed of items including mycobacterial test methods, test volume, turnaround time (TAT), and quality control measure. It was sent to 90 laboratories of general hospitals, tuberculosis specialty hospitals and commercial laboratories in April 2001. RESULTS: Sixty-seven (74%) of 90 laboratories replied to this survey. Five of 67 laboratories (7%) were using fluorochrome method for AFB stains. In five among 58 laboratories that performed AFB cultures (8%), liquid media have been used. Mycobacterial species was identified by molecular biologic methods or high-performance liquid chromatography in 18 laboratories (34%). Average TAT of culture and identification for Mycobacterium tuberculosis was 11 days at the laboratory using Mycobacteria Growth Indicator Tube (MGIT) 9600 system and PCR method, while that at the laboratory using Ogawa media and biochemical method was 35.8 days. TATs of susceptibility tests undertaken at three laboratories were 28-60 days. Only six laboratories were joining external quality control program, even though most laboratories wanted to participate in. CONCLUSIONS: TATs for mycobacterial culture and susceptibility tests were too long to have the laboratories take a pivotal role to control tuberculosis. To improve Korean mycobacterial laboratories, it is necessary that the national health insurance system supports the newer rapid methods for mycobacterial tests and nationwide external quality control program is introduced.