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Head injury is a potentially lethal and frequently occurring condition in the emergency department (ED). Reliable and fast diagnosis is important both for patients and flow in the ED. Circulating S100B is used to rule out the need for head computer tomography in low-risk patients with mild head injury. The flow of these patients through the ED would benefit from shorter turn-around time. Standard serum clotting tubes require 30-60 min clotting time, followed by an analysis time of 45 min. Here, we evaluated the performance of two alternative blood collection tubes; a rapid serum tube (RST) with a recommend clotting time of 5 min and a hirudin tube (HIR) for instant anticoagulation. S100B measurement was performed on paired blood samples from 221 subjects using a Roche Cobas 602 analyser. The performances of the alternative tubes were evaluated by method comparison to the standard serum clotting tube, repeatability and agreement of results obtained from alternative tubes compared with the standard clotting tube. Both alternative tubes had a minor positive bias (RST = 0.011 µg/L, HIR = 0.008 µg/L). The repeatability was 2% for RST and 10% for HIR, while being 4% for the standard clotting tube. In the agreement analysis, the positive and negative predictive values for RST were 62% and 100% while being 73% and 99% for HIR respectively. Our study suggests that RST is a feasible alternative to reduce laboratory turn-around time in S100b analysis.

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This study compared laboratory risk and turn-around time (TAT) between sequence-based typing (SBT) and next-generation sequencing (NGS) for human leukocyte antigen (HLA) typing. For risk assessment, we utilized the risk priority number (RPN) score based on failure mode and effect analysis (FMEA) and a risk acceptability matrix (RAM) according to the Clinical Laboratory Standards Institute (CLSI) guidelines (EP23-A). Total TAT was documented for the analytical phase, and hands-on time was defined as manual processes conducted by medical technicians. NGS showed a significantly higher total RPN score than SBT (1169 vs. 465). NGS indicated a higher mean RPN score, indicating elevated severity and detectability scores in comparison to SBT (RPN 23 vs. 12, p = 0.001; severity 5 vs. 3, p = 0.005; detectability 5 vs. 4, p < 0.001, respectively). NGS required a greater number of steps than SBT (44 vs. 25 steps), all of which were acceptable for the RAM. NGS showed a longer total TAT, total hands-on time, and hands-on time per step than SBT (26:47:20 vs. 12:32:06, 03:59:35 vs. 00:47:39, 00:05:13 vs. 00:01:54 hh:mm:ss, respectively). Transitioning from SBT to NGS for HLA typing involves increased risk and an extended TAT. This study underscored the importance of evaluating these factors to optimize laboratory efficiency in HLA typing.

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RT-PCR is the gold standard for diagnosis of COVID-19. All RT-PCR kits are based on RNA extraction from the clinical sample. There was a sudden increase in demand of these kits, both RNA extraction and COVID-19 RT-PCR kits during the pandemic. This sudden spurt in global demand created a situation of shortage of consumables, especially the RNA extraction kits. Hence, this study was carried out to evaluate and compare COVID-19 RT-PCR without RNA extraction step using buffer R3. Sensitivity, specificity and accuracy of RT-PCR kit without RNA extraction were 89.16 %, 100% and 89.6% respectively. This approach saved more than 50 % time compared to the RT-PCR kit with RNA extraction approach allowing enhanced daily sample processing capability. RT-PCR kit without RNA extraction help in managing a greater number of samples, reduces cost and turnaround time.

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SETTING: On a programmatic basis, a new regimen was introduced in the National Tuberculosis Elimination Programme for isoniazid monoresistant tuberculosis in a few states in India. OBJECTIVE: To describe the clinical attributes and treatment outcomes of isoniazid mono-resistant tuberculosis patients on the new 6-month levofloxacin-containing regimen in Puducherry, India. DESIGN: The study is designed as a convergent parallel mixed-methods study: a retrospective cohort study and a descriptive qualitative study. A total of 180 Hr-TB patient health records were reviewed, and in-depth interviews with 35 participants were conducted. (20 Hr-TB patients and 15 HCWs). RESULTS: Of the total 180 Hr-TB patients included, we documented unfavourable outcomes in 26.1% of cases, and the KatG gene mutation was the most common mutation observed (63.9%). A significant risk of unfavourable outcomes was associated with low adherence and positive sputum at the third-month culture report. In interviewing the stakeholders, major challenges observed were the increased pill burden, delay in diagnosis, shortage of drugs, and lack of staff. CONCLUSION: Hr-TB patients have difficulty in adhering to the 6-month levofloxacin regimen, with the need for rigorous early 3-month follow-up and assessment.

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BACKGROUND: Early and appropriate antibiotic treatment improves the clinical outcome of patients with sepsis. There is an urgent need for rapid identification (ID) and antimicrobial susceptibility testing (AST) of bacteria that cause bloodstream infection (BSI). Rapid ID and AST can be achieved by short-term incubation on solid medium of positive blood cultures using MALDI-TOF mass spectrometry (MS) and the BD M50 system. The purpose of this study is to evaluate the performance of rapid method compared to traditional method. METHODS: A total of 124 mono-microbial samples were collected. Positive blood culture samples were short-term incubated on blood agar plates and chocolate agar plates for 5 ∼ 7 h, and the rapid ID and AST were achieved through Zybio EXS2000 MS and BD M50 System, respectively. RESULTS: Compared with the traditional 24 h culture for ID, this rapid method can shorten the cultivation time to 5 ∼ 7 h. Accurate organism ID was achieved in 90.6% of Gram-positive bacteria (GP), 98.5% of Gram-negative bacteria (GN), and 100% of fungi. The AST resulted in the 98.5% essential agreement (EA) and 97.1% category agreements (CA) in NMIC-413, 99.4% EA and 98.9% CA in PMIC-92, 100% both EA and CA in SMIC-2. Besides, this method can be used for 67.2% (264/393) of culture bottles during routine work. The mean turn-around time (TAT) for obtaining final results by conventional method is approximately 72.6 ± 10.5 h, which is nearly 24 h longer than the rapid method. CONCLUSIONS: The newly described method is expected to provide faster and reliable ID and AST results, making it an important tool for rapid management of blood cultures (BCs). In addition, this rapid method can be used to process most positive blood cultures, enabling patients to receive rapid and effective treatment.

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INTRODUCTION: Africa is the second-largest continent on Earth in terms of both size and population. However, inaccessibility and shortfall of trained radiologists impede the delivery of adequate healthcare to such a large population. Teleradiology holds considerable potential in improving patient outcomes and healthcare delivery in African nations by furnishing timely interpretation of radiological examinations, particularly in those areas where there is a particular scarcity of radiologists. The aim of the present study was to assess the impact of teleradiology in the improvement of healthcare and patient management in the developing countries of the African continent. METHODS: In this retrospective study, from January 2017 and December 2022, the scans of a cohort of patients from eight African countries were uploaded to the teleradiology cloud server and interpreted by board certified radiologists empanelled by a teleradiology service provider. RESULTS: The telehealth model proposed in the study was seen to provide timely and quality reporting of 58,223 scans of 39,513 patients with a mean turn-around-time (TAT) of 2.46 h 95 % CI (2.44-2.48). DISCUSSION: A dedicated teleradiology model designed in this study allowed the interpretation and analysis of the scans of the cohort of patients from hospitals in African countries by teleradiologists via high quality DICOM-image transfer over a cloud-based platform. The outcomes of our investigation reflect that teleradiology provides an effective solution for early diagnosis/interpretation of examinations performed in Africa. Further, the currently proposed teleradiology model may be used for other developing countries across the world to improve quality of care.

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BACKGROUND: Sepsis is a major health problem worldwide and is associated with high morbidity and mortality with every hour delay in initiation of therapy. A conventional method of blood culture and Antimicrobial Susceptibility Testing (AST) takes around 48-72 hours. Empirical antibiotics need to be administered until the sensitivity report is made available. It has been estimated that 20-50% of the empirical antibiotics are inappropriate, resulting in prolonged hospital stays, adverse effects, and emergence of drug resistance. Additionally, this also puts an extra financial burden on both the patients and healthcare settings. Performing direct Antimicrobial Sensitivity Testing (dAST) is an important tool to reduce turn-around time (TAT) by at least 18-24 hours, thus reducing morbidity and mortality among critically ill patients. METHODS: Direct AST (dAST) was performed from the positively flagged blood culture bottles received between December, 2021 to May, 2022 from Intensive Care Units (ICUs) on Mueller- Hinton Agar (MHA) using four drops of withdrawn blood. dAST was performed for six drugs: Ceftriaxone-30 µg (CTR), Piperacillin/Tazobactam-100/10 µg (PIT), Meropenem-10 µg (MRP), Ciprofloxacin-5 µg (CIP), Aztreonam-30 µg (AT), and Colistin (CL). The zone of inhibition was interpreted as per CLSI M100 ed32, 2022 guidelines. A parallel conventional method was also performed to examine for categorical agreement and disagreement. Identification was carried out using MALDI-TOF MS from the colonies that appeared on the dAST plate on the subsequent day. RESULTS: A total of 162 positively flagged blood culture bottles were included in the study. The majority of the Gram-negative organisms were from Enterobacterales (n=109), followed by Acinetobacter spp. (n=28) and Pseudomonas aeruginosa (n=25). Out of the 972 isolate-antimicrobial combinations, overall Categorical Agreement (CA) was seen in 936 (96.3%), whereas disagreement was observed in 36 with minor error (mE) in 21 (2.2%), major error (ME) in 7 (0.7%), and very major error (VME) in 8 (0.8%) when compared to the routine method. Categorical agreement (CA) of > 99% was seen in ceftriaxone (CTR) and ciprofloxacin (CIP). In comparison, the lowest CA was observed with meropenem (MRP) at 92%. Colistin dAST was performed using the E-strip method, and the result obtained was highly convincing, with an overall disagreement of only 1.2%. CONCLUSION: Rapid dAST from positively flagged blood culture bottles proved to significantly reduce the TAT from the time of sample collection to the first availability of antimicrobial susceptibility report with excellent categorical agreement of > 95% using the conventional disc diffusion method. Results obtained were within the acceptance criteria set by U. S. Food and Drug Administration (FDA) guidelines of > 90% categorical agreement for a new method. We were able to obtain excellent concordance for colistin using the E-strip method. Performing dAST not only saves a "day", but its proper implementation would save a "life".

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OBJECTIVE: To explore the application effects of information technology (IT) on emergency laboratory testing procedures. METHODS: In this study, IT-based optimisation of the emergency laboratory testing process was implemented between October and December 2021. Thus, the emergency laboratory test reports from January to September 2021 were placed into the pre-optimised group, while those from January to September 2022 were categorised into the post-optimised group. Besides, the emergency laboratory test report time, emergency laboratory test report time limit coincidence rate, error rate, and employee and patient satisfaction levels in individual months and across the whole period were described. Moreover, changes in the above indicators before and after the implementation of IT-based optimisation were explored and the application effects of IT-based optimisation were also evaluated. RESULTS: The emergency laboratory test report times after the implementation of IT-based optimisation were shorter than those before IT-based optimisation (P < 0.05). The total number of laboratory test items before and after information optimization amounted to 222,139 and 259,651, respectively. Also, IT-based optimisation led to an increase in the emergency laboratory test report time limit coincidence rate from 98.77% to 99.03% (P < 0.05), while the emergency laboratory test report error rate fell from 0.77‱ to 0.15‱ (P < 0.05). Additionally, IT-based optimisation resulted in increases in both employee satisfaction, from 80.65% to 93.55% (N = 31, P > 0.05), and patient satisfaction, from 93.06% to 98.44% (P < 0.05). CONCLUSION: The automation and IT-based optimisation of the emergency laboratory testing process significantly reduces the emergency laboratory test report time and error rate. Additionally, IT-driven optimization enhances the alignment of emergency laboratory test report deadlines and enhances the overall quality and safety of emergency laboratory testing.

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BACKGROUND: Laboratory Automation (LA) is an innovative technology that is currently available for microbiology laboratories. LA can be a game changer by revolutionizing laboratory workflows through efficiency improvement and is also effective in the organization and standardization of procedures, enabling staff requalification. It can provide an important return on investment (time spent redefining the workflow as well as direct costs of instrumentation) in the medium to long term. METHODS: Here, we present our experience with the WASPLab® system introduced in our lab during the COVID-19 pandemic. We evaluated the impact due to the system by comparing the TAT recorded on our samples before, during, and after LA introduction (from 2019 to 2021). We focused our attention on blood cultures (BCs) and biological fluid samples (BLs). RESULTS: TAT recorded over time showed a significant decrease: from 97 h to 53.5 h (Δ43.5 h) for BCs and from 73 h to 58 h (Δ20 h) for BLs. Despite the introduction of the WASPLab® system, we have not been able to reduce the number of technical personnel units dedicated to the microbiology lab, but WASPLab® has allowed us to direct some of the staff resources toward other laboratory activities, including those required by the pandemic. CONCLUSIONS: LA can significantly enhance laboratory performance and, due to the significant reduction in reporting time, can have an effective impact on clinical choices and therefore on patient outcomes. Therefore, the initial costs of LA adoption must be considered worthwhile.

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Introduction PTS (pneumatic transport system) is extensively being used in modern hospitals for rapid transportation of blood samples and other specimens. However, it has a potential impact on blood components, which should be investigated and nullified accordingly. This study was part of a correction program aimed at reducing hemolysis. It was done by comparing paired samples transported manually and by PTS. Materials and Methods This study was initiated to monitor the impact of PTS on hemolysis of clinical biochemistry blood samples. It was performed in two phases-before and after the corrective action taken. Phase I: done after PTS installation but before the corrective action was taken. Duplicate samples from 100 healthy individuals were collected, one set transported by PTS and the other by human carriers. Both sets were assessed for 25 biochemistry analytes, hemolysis index (HI), and acceleration profiles using a data logger. Corrective measures were then taken, followed by phase II of the study. In phase II, the sample size and study design remained the same as phase I. All the test results of PTS and hand-carried samples were statistically analyzed for any significant difference. Result In phase I, all the hemolysis-manifesting parameters, LDH (lactate dehydrogenase), potassium, AST (aspartate transaminase), and phosphorus, were raised in PTS samples as compared with the manual samples. Their differences were significant as the p -values were 0.001, 0.000, 0.025, and 0.047, respectively. The differences for LDH and potassium were clinically significant as well. HI (9%) and peak acceleration (15.7 g) were high in PTS samples. In phase II, no statistically significant difference between paired samples was found for all biochemistry parameters except for a few which were clinically nonsignificant. For PTS samples, HI was 2.5% and the peak acceleration was 11.2 g, whereas for manual samples, HI was 2%. Conclusion Evidence of hemolysis was found in PTS samples as compared with handheld samples, which was resolved after several corrective actions were taken. Thereafter, PTS became reliable for sample delivery in a routine biochemistry laboratory. Hence, each hospital should scrutinize their PTS for its effects on sample integrity to get rid of PTS-induced preanalytical errors.

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India has been implementing one of the biggest Early Infant Diagnosis (EID) of HIV intervention globally. The turn-around-time (TAT) for EID test is one of the major factors for success of the program. This study was to assess the turnaround time and its determinants. It is a mixed methods study with quantitative analysis of retrospective data (2013-2016) collected from all the 7 Early Infant Diagnosis testing laboratories (called as regional reference laboratories or RRLs) in India and qualitative component that can help explain the determinants of turn-around-time. The retrospective national level data available from the RRLs was analyzed to measure the turn-around-time from the receipt of samples to the dispatch of results and to understand the determinants for the same. The 3 components transport time, testing time, and dispatch time were also calculated. Transport time was analyzed state-wise and the testing time RRL wise to understand disparities, if any. Qualitative interviews with the RRL officials were conducted to understand the underlying determinants of TAT. The Median turn-around-time ranged between 29 and 53 days over the 4 years. Transport time was significantly higher for states without RRL (42 days) than those with RRL (27 days). Testing time varied from RRL to RRL and was associated with incomplete forms, inadequate samples, kits logistics, staff turnover, staff training, and instrument related issues. The TAT is high and can be potentially reduced with interventions, such as decentralization of RRLs; courier systems for sample transport; and ensuring adequate resources at the RRL level.

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Primary care practices face significant challenges as they pursue the Quadruple Aim. Redistributing care across the interprofessional primary care team by expanding the role of the medical assistant (MA) is a potential strategy to address these challenges. Two sequential, linked processes to expand the role of the MA, called Enhanced Rooming and Visit Assistance, were implemented in four family medicine residency clinics in Minnesota. In Enhanced Rooming, MAs addressed preventive services, obtained a preliminary visit agenda, and completed a warm hand-off to the provider. In Visit Assistance, MAs stayed in the room the entire visit to assist with the visit workflow. Enhanced Rooming and Visit Assistance processes were successfully implemented and sustained for over one year. MAs and providers were satisfied with both processes, and patients accepted the expanded MA roles. Mammogram ordering rates increased from 10% to 25% (p < 0.0001). After Visit Summary (AVS) print rates increased by 12% (p < 0.0001). Visit Turn-Around-Time (TAT) decreased 3.1 minutes per visit (p = 0.0001). Expanding the MA role in a primary care interprofessional team is feasible and a potentially useful tool to address the Quadruple Aim.

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Quantity not sufficient (QNS) specimens with minimal blood volume for testing are common in clinical laboratories. However, there is no universal definition of minimum volume for a QNS specimen and little data is available addressing the impact of QNS / low volume specimens on turnaround time (TAT) and sample hemolysis. We compared the TAT and hemolysis index from samples ≤1.0 mL to all specimens received and quantified the number of specimens with reduced blood volume. A new QNS policy requiring ≥1.5 mL of sample in a blood tube for laboratory analysis was implemented and the results were assessed by sample hemolysis and TAT. The median laboratory TAT for samples with ≤1.0 mL of blood was 61 min (Interquartile Range, IQR: 50-82), in contrast to 28 min (26-34) for all samples. The hemolysis index for samples ≤1.0 mL was 112 (65-253) and 15 (8-29) for all samples. Requirement of a minimum volume of 1.5 mL of blood resulted in the proportion of samples with TAT ≥ 60 min to decrease from 10.4% to 4.24% in the ED, and for specimens cancelled due to hemolysis to decrease from 4.24% to 3.38%. This policy was introduced hospital wide with similar effects. Together, we correlate limited specimen volume with an increase in laboratory TAT and hemolysis. Implementation of a QNS policy of ≥1.5 mL and provider education provided a significant and durable reduction in TAT and specimen hemolysis.

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Turnaround time (TAT), which doctors frequently use as the benchmark for laboratory performance, is a typical way to communicate timeliness. It also acts as a quality indicator to evaluate the effectiveness and efficiency of the testing process and the satisfaction of clinicians and patients. TAT is the time from receipt of the sample in the laboratory to final delivery or dispatch of the report of said test. The TAT procedure can be broadly divided into three stages pre-analytical, analytical and post-analytical. There is variability in TAT according to different conditions like the volume of sample size, staff expertise, availability of adequate resources, distances of the hospital from the lab, and various sub-departments. To remove obstacles to optimizing TAT, we must take a practical approach. A workload reduction plan, proper stock management, specialized work assignments, and skilled staff retention are crucial strategies to reduce the setting's delayed TAT.

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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 = 43 346) and data on rejected HIV PCR requests (n = 1479) at the Tygerberg virology laboratory over two years (2017-2019). 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.

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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.

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A diagnostic algorithm for SARS-CoV-2 infection in patients admitted to the emergency area, based on a combination of rapid antigen and molecular testing, has been evaluated with 3070 nasopharyngeal swabs. Compared to molecular test alone, the proposed algorithm allowed to significantly reduce costs and average time to results.

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Several professional societies advise against using real-time Reverse-Transcription PCR (rtRT-PCR) cycle threshold (Ct) values to guide clinical decisions. We comparatively assessed the variability of Ct values generated by six diagnostic approaches by testing serial dilutions of well-characterized isolates of 10 clinically most relevant SARS-CoV-2 genomic variants: Alpha, Beta, Gamma, Delta, Eta, Iota, Omicron, A.27, B.1.258.17, and B.1 with D614G mutation. Comparison of three fully automated rtRT-PCR analyzers and a reference manual rtRT-PCR assay using RNA isolated with three different nucleic acid isolation instruments showed substantial inter-variant intra-test and intra-variant inter-test variability. Ct value differences were dependent on both the rtRT-PCR platform and SARS-CoV-2 genomic variant. Differences ranging from 2.0 to 8.4 Ct values were observed when testing equal concentrations of different SARS-CoV-2 variants. Results confirm that Ct values are an unreliable surrogate for viral load and should not be used as a proxy of infectivity and transmissibility, especially when different rtRT-PCR assays are used in parallel and multiple SARS-CoV-2 variants are circulating. A detailed turn-around time (TAT) comparative assessment showed substantially different TATs, but parallel use of different diagnostic approaches was beneficial and complementary, allowing release of results for more than 81% of non-priority samples within 8 h after admission.

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Early detection of Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) variants and use of data for public health action requires a coordinated, rapid, and high throughput approach to whole genome sequencing (WGS). Currently, WGS output from many low- and middle-income countries (LMIC) has lagged. By fostering diverse partnerships and multiple sequencing technologies, Indonesia accelerated SARS-CoV-2 WGS uploads to GISAID from 1,210 in April 2021 to 5,791 in August 2021, an increase from 11 submissions per day between January to May, to 43 per day between June to August. Turn-around-time from specimen collection to submission decreased from 77 to 5 days, allowing for timely public health decisions. These changes were enabled by establishment of the National Genomic Surveillance Consortium, coordination between public and private sector laboratories with WGS capability, and diversification of sequencing platform technologies. Here we present how diversification on multiple levels enabled a rapid and significant increase of national WGS performance, with potentially valuable lessons for other LMICs.