Polymerase Chain Reaction-based Test Research Articles

GeneXpert MTB/RIF Ultra vs Unstimulated Interferon γ (IRISA-TB) for the Diagnosis of Tuberculous Pericarditis in a Tuberculosis-Endemic Setting.

Tuberculous pericarditis (TBP) is a paucibacillary disease, where host biomarkers such as unstimulated interferon γ (IRISA-TB) have high diagnostic accuracy. However, DNA-based diagnostic tests (GeneXpert Ultra), more sensitive than an earlier versions, have recently become available. Given that the diagnosis of TBP is challenging, we performed a comparative diagnostic accuracy study comparing both assays. We recruited 99 consecutive patients with suspected TBP in Cape Town, South Africa. Definite TBP was defined by microbiological confirmation of tuberculosis (TB) on pericardial fluid culture or an alternative polymerase chain reaction-based test (GeneXpert MTB/RIF) or by use of sputum (polymerase chain reaction or culture). Probable TBP was defined as a high clinical suspicion of TB accompanied by anti-TB treatment, while non-TBP was defined as negative microbiological test results for TB without initiation of TB treatment and/or the presence of an alternative diagnosis. There were 39 patients with definite TBP, 35 with probable TBP, and 23 with non-TBP. Approximately 70% of participants who received TB treatment were HIV coinfected. Overall, IRISA-TB was more sensitive than Xpert Ultra (88.6% [95% CI, 74.1%-95.5%] vs 71.5% [55.0%-83.7%], n = 53) and significantly more sensitive in participants who were HIV uninfected (100% [95% CI, 72.3%-100.0%] vs 60% [31.3%-83.2%], P = .03). In patients with definite and probable TBP combined (n = 84), sensitivity was significantly higher with IRISA-TB (77.3% [95% CI, 65.9%-85.8%] vs 37.9 [27.2%-50.0%], P < .0001). A similar pattern was seen in persons who were HIV uninfected (88.3% vs 35.3%, P = .002). Specificity was high for both assays (>95%). Unstimulated interferon γ (IRISA-TB) was significantly more sensitive than Xpert Ultra for the diagnosis of TB pericarditis in a TB-endemic resource-poor setting.

Clinical utility of the Oncomine Dx Target Test multi-CDx system and the possibility of utilizing those original sequence data.

Companion diagnostic tests play a crucial role in guiding treatment decisions for patients with non-small cell lung cancer (NSCLC). The Oncomine Dx Target Test (ODxTT) Multi-CDx System has emerged as a prominent companion diagnostic method. However, its efficacy in detecting driver gene mutations, particularly rare mutations, warrants investigation. This study aimed to assess the performance of the ODxTT in detecting driver gene mutations in NSCLC patients. Specifically, we aimed to evaluate its sensitivity in detecting epidermal growth factor receptor (EGFR) mutations, a key determinant of treatment selection in NSCLC. We conducted a retrospective analysis of NSCLC patients who underwent testing with the ODxTT at Keio University Hospital between May 2020 and March 2022. Patient samples were subjected to both DNA and RNA tests. Driver gene mutation status was assessed, and instances of missed mutations were meticulously examined. Of the 90 patients, five had nucleic acid quality problems, while 85 underwent both DNA and RNA tests. Driver gene mutations were detected in 56/90 (62.2%) patients. Of the 34 patient specimens, driver mutations were not detected using the ODxTT; however, epidermal growth factor receptor (EGFR) mutations were detected using polymerase chain reaction-based testing in two patients, and a KRAS mutation was detected by careful examination of the sequence data obtained using the ODxTT in one patient. For the above three cases, carefully examining the gene sequence information obtained using the ODxTT could identify driver mutations that were not mentioned in the returned test results. Additionally, we confirmed comparable instances of overlook results for EGFR mutations in the dataset from South Korea, implying that this type of oversight could occur in other countries using the ODxTT. EGFR mutation was missed in ODxTT in Japan (6.3%, 2/32), South Korea (2.0%, 1/49), and overall (3.7%, 3/81). Even if sufficient tumor samples are obtained, rare EGFR mutations (which are excluded from the ODxTT's genetic mutation list) might not be detected using the current ODxTT system due to the program used for sequence analysis. However, such rare EGFR mutations can still be accurately detected on ODxTT's sequence data using next-generation sequencing.

Nivolumab (NIVO) plus ipilimumab (IPI) vs chemotherapy (chemo) as first-line (1L) treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): First results of the CheckMate 8HW study.

LBA768 Background: Patients (pts) with MSI-H/dMMR mCRC have poor outcomes with standard chemo ± targeted therapies. NIVO ± IPI are approved in previously treated pts with MSI-H/dMMR mCRC in many countries, based on the phase 2 CheckMate 142 study. CheckMate 8HW (NCT04008030) is a randomized phase 3 study comparing NIVO + IPI with NIVO or chemo in pts with MSI-H/dMMR mCRC. We report progression-free survival (PFS) by blinded independent central review (BICR) at a prespecified interim analysis for NIVO + IPI vs chemo in the 1L setting. Methods: Pts ≥ 18 years with recurrent or mCRC not amenable to surgery and MSI-H/dMMR status per local testing were enrolled across different lines of therapy. Previously untreated pts were randomized 2:2:1 to NIVO (240 mg) + IPI (1 mg/kg) Q3W (4 doses, then NIVO 480 mg Q4W), NIVO (240 mg) Q2W (6 doses, then NIVO 480 mg Q4W), or chemo ± targeted therapies; treatments continued until disease progression or unacceptable toxicity (all arms), or a maximum of 2 years (NIVO ± IPI arms). For pts with BICR-documented progression with chemo, optional crossover to NIVO + IPI was permitted. Dual primary endpoints were PFS by BICR per RECIST v1.1 for NIVO + IPI vs chemo (1L) and NIVO + IPI vs NIVO (all lines) in pts with centrally confirmed MSI-H/dMMR mCRC. Results: In the 1L setting, 303 pts were randomized to NIVO + IPI (n = 202) or chemo (n = 101); of these pts, 171 pts in the NIVO + IPI arm and 84 pts in the chemo arm had centrally confirmed MSI-H/dMMR result by either immunohistochemistry and/or polymerase chain reaction-based tests. With 24.3 months of median follow-up, NIVO + IPI demonstrated clinically meaningful and statistically significant improvement in PFS vs chemo, with a 79% reduction in the risk of disease progression or death (HR 0.21 [95% CI 0.14–0.32]; P &lt; 0.0001) (Table). No new safety signals were identified (Table). Conclusions: NIVO + IPI demonstrated superior PFS vs chemo in previously untreated pts with MSI-H/dMMR mCRC. NIVO + IPI had a different safety profile compared to chemo, with fewer grade 3–4 treatment-related adverse events (TRAEs). These results support 1L NIVO + IPI as a standard-of-care option for pts with MSI-H/dMMR mCRC. Clinical trial information: NCT04008030 . [Table: see text]

Clinical performance evaluation of TAQPATH Enteric Bacterial Select Panel for the detection of common enteric bacterial pathogens in comparison to routine stool culture and other qPCR-based diagnostic tests.

Enteric bacterial infections caused by Salmonella, Shigella, pathogenic Escherichia coli, and Campylobacter represent one of the most common causes of infectious enteritis worldwide. The timely and accurate diagnosis of pathogens causing gastroenteritis is crucial for patient care, public health, and disease surveillance. While stool culture has long been the standard and highly specific method for detecting enteric pathogens, it is labor-intensive and time-consuming with limited sensitivity. To improve patient outcomes, there is a need to implement new cost-effective approaches for the detection of bacterial enteric pathogens with higher sensitivity and faster time to result. This study shows that multiplex real-time polymerase chain reaction-based tests, such as the TAQPATH Enteric Bacterial Select Panel, are accurate and cost-effective diagnostic alternatives for the detection and differentiation of the most common enteric bacterial pathogens, offering quicker time to result and higher sensitivity compared to routine stool culture.

Ultrasensitive and Specific Clustered Regularly Interspaced Short Palindromic Repeats Empowered a Plasmonic Fiber Tip System for Amplification-Free Monkeypox Virus Detection and Genotyping.

The urgent necessity for highly sensitive diagnostic tools has been accentuated by the ongoing mpox (monkeypox) virus pandemic due to the complexity in identifying asymptomatic and presymptomatic carriers. Traditional polymerase chain reaction-based tests, despite their effectiveness, are hampered by limited specificity, expensive and bulky equipment, labor-intensive operations, and time-consuming procedures. In this study, we present a clustered regularly interspaced short palindromic repeats (CRISPR)/Cas12a-based diagnostic platform with a surface plasmon resonance-based fiber tip (CRISPR-SPR-FT) biosensor. The compact CRISPR-SPR-FT biosensor, with a 125 μm diameter, offers high stability and portability, enabling exceptional specificity for mpox diagnosis and precise identification of samples with a fatal mutation site (L108F) in the F8L gene. The CRISPR-SPR-FT system can analyze viral double-stranded DNA from mpox virus without amplification in under 1.5 h with a limit of detection below 5 aM in plasmids and about 59.5 copies/μL when in pseudovirus-spiked blood samples. Our CRISPR-SPR-FT biosensor thus offers fast, sensitive, portable, and accurate target nucleic acid sequence detection.

Evidence-based approach to diagnosis and management of abdominal tuberculosis.

Abdominal tuberculosis is an ancient problem with modern nuances in diagnosis and management. The two major forms are tuberculous peritonitis and gastrointestinal tuberculosis (GITB), while the less frequent forms are esophageal, gastroduodenal, pancreatic, hepatic, gallbladder and biliary tuberculosis. The clinicians need to discriminate the disease from the close mimics: peritoneal carcinomatosis closely mimics peritoneal tuberculosis, while Crohn's disease closely mimics intestinal tuberculosis. Imaging modalities (ultrasound, computed tomography, magnetic resonance imaging and occasionally positron emission tomography) guide the line of evaluation. Research in diagnostics (imaging and endoscopy) has helped in the better acquisition of tissue for histological and microbiological tests. Although point-of-care polymerase chain reaction-based tests (e.g. Xpert Mtb/Rif) may provide a quick diagnosis, these have low sensitivity. In such situations, ancillary investigations such as ascitic adenosine deaminase and histological clues (granulomas, caseating necrosis, ulcers lined by histiocytes) may provide some specificity to the diagnosis. A diagnostic trial of antitubercular therapy (ATT) may be considered if all diagnostic armamentaria fail to clinch the diagnosis, especially in TB-endemic regions. Objective evaluation with clear endpoints of response is mandatory in such situations. Early mucosal response (healing of ulcers at twomonths) and resolution of ascites are objective criteria for early response assessment and should be sought at twomonths. Biomarkers, especially fecal calprotectin for intestinal tuberculosis, have also shown promise. For most forms of abdominal tuberculosis, sixmonths of ATT is sufficient. Sequelae of GITB may require endoscopic balloon dilatation for intestinal strictures or surgical intervention for recurrent intestinal obstruction, perforation or massive bleeding.

Operational impact of decreased turnaround times for Candida auris screening tests in a tertiary academic medical center.

Assess turnaround time (TAT) and cost-benefit of on-site C. auris screening and its impact on length of stay (LOS) and costs compared to reference laboratories. Before-and-after retrospective cohort study. Large-tertiary medical center. We validated an on-site polymerase chain reaction-based testing platform for C. auris and retrospectively reviewed hospitalized adults who screened negative before and after platform implementation. We constructed multivariable models to assess the association of screening negative with hospital LOS/cost in the pre and postimplementation periods. We adjusted for confounders such as demographics and indwelling device use, and compared TATs for all samples tested. The sensitivity and specificity of the testing platform were 100% and 98.11%, respectively, compared to send-out testing. The clinical cohort included 287 adults in the pre and 1,266 postimplementation period. The TAT was reduced by more than 2 days (3 (interquartile range (IQR): 2.0, 7.0) vs 0.42 (IQR: 0.24, 0.81), p < 0.001). Median LOS was significantly lower in the postimplementation period; however, this was no longer evident after adjustment. In relation to total cost, the time period had an effect of $6,965 (95% CI: -$481, $14,412); p = 0.067) on reducing the cost. The median adjusted total cost per patient was $7,045 (IQR: $3,805, $13,924) less in the post vs the preimplementation period. Our assessment did not find a statistically significant change in LOS, nevertheless, on-site testing was not cost-prohibitive for the institution. The value of on-site testing may be supported if an institutional C. auris reduction strategy emphasizes faster TATs.

27. Review and comparison of the Oncomine Myeloid Assay GX v2 on Genexus System

Rapid molecular results for FLT3, IDH1/2 and NPM1 are necessary for treatment decisions of newly diagnosed acute leukemia patients. However, as treatment protocols and clinical trials request more gene variants with a faster turnaround time, single gene STAT testing using polymerase chain reaction-based testing becomes more cumbersome for the molecular diagnostic laboratory. Therefore, a rapid next generation sequencing panel for acute leukemias is necessary for laboratory operations and, more importantly, clinical utility. Cedars-Sinai molecular pathology laboratory validated the automated Oncomine? Myeloid Assay GX v2 panel using the Ion Torrent? Genexus? Integrated Sequencer (v.6.6) for a 24-hour turnaround time from DNA and RNA purification to variant reporting. We compared the results from Oncomine? Myeloid Assay GX v2 panel to Archer® VariantPlex® Myeloid panel on Illumina-based platforms. The differences between the two systems include technician intervention, turnaround time, variant accuracy, and the usability of the software package. While Archer® VariantPlex® Myeloid panel demonstrates unrivaled accuracy and reliability, the ThermoFisher Myeloid Assay GX v2 using the Genexus (IonTorrent sequencing) offers quick results and fusion detection. Therefore, we have chosen to implement both systems as standard clinical diagnostics for new acute leukemia patients.

Effect of mismatch between types of viral nucleic acid and intended targets of extraction kits on polymerase chainreaction-based testing.

Lab personnel generally select an extraction kit based on the nucleic acid (NA) type of the target. This study investigated the effect of mismatch between the NA type of the target and the intended target NA of the extraction kit on the polymerase chain reaction outcome. DNA, RNA and total NA extraction kits manufactured by the same company were used to isolate NA from serial dilutions of four viruses representing different genome types. All extracts were tested for the viruses by either conventional or real-time polymerase chain reactions with and without reverse transcription. While the DNA kit specifically isolated DNA from samples, the RNA kit extracted both DNA and RNA as efficiently as the total NA kit, suggesting that RNA kits can be an economical alternative.

POS-011 PRIMARY ATYPICAL HEMOLYTIC-UREMIC SYNDROME ASSOCIATED WITH COVID-19: A BRIEF REVIEW

POS-011 PRIMARY ATYPICAL HEMOLYTIC-UREMIC SYNDROME ASSOCIATED WITH COVID-19: A BRIEF REVIEW

Biomarker Testing for Patients With Advanced/Metastatic Nonsquamous NSCLC in the United States of America, 2015 to 2021

IntroductionNSCLC is a solid tumor with a growing number of actionable biomarkers that may inform treatment. Current guidelines recommend a broad, panel-based approach be taken to identify actionable markers. This retrospective study used a deidentified electronic health records database in the United States to evaluate utilization of various testing modalities. MethodsData from all adult patients diagnosed with having advanced/metastatic nonsquamous NSCLC between January 2015 and March 2021 were eligible if there was evidence of systemic therapy within 90 days of diagnosis. ResultsRecords from a total of 17,513 patients (91.6% from community-based practices) were eligible with 83,064 genomic biomarker tests recorded from 2015 to 2021. The proportion of patients who received biomarker testing by next-generation sequencing (NGS)-based methods ranged from 28.3% in 2015 to 68.1% in 2020. The proportion of biomarker testing methods with inconclusive or unsuccessful results ranged from 3.4% for NGS to 9.7% for fluorescence in situ hybridization. The median time to receive results ranged from 4.0 days for polymerase chain reaction-based tests to 10.0 days for immunohistochemistry- and NGS-based tests. Median time to receive results was 8 days for academic and 9 days for community practices. ConclusionsThese real-world data suggest increased adoption of NGS-based testing, yet nearly one-third of all patients with advanced/metastatic nonsquamous NSCLC still did not receive broad-based genomic testing by 2020.

Chronic Tropheryma whipplei infection: an important differential diagnosis of refractory polyarthritis

Refractory arthritis is acommon problem in routine rheumatology practice, and can be adiagnostic challenge. In these cases, chronic Tropheryma whipplei (T.whipplei) infection is an important differential diagnosis that should be considered. Based on five clinical cases, this case-based review describes the diagnostic and therapeutic principles in the management of chronic T.whipplei infection. Whipple's disease is amultisystemic infectious disease caused by the bacterium T.whipplei. The disease typically manifests with arthralgia, weight loss and diarrhoea. Joint involvement often develops years before gastrointestinal symptoms occur. In addition to systemic manifestations ("classic Whipple's disease"), T.whipplei can also lead to localized joint infections without gastrointestinal involvement. Articular manifestations of systemic and localized T.whipplei infections are commonly misdiagnosed as a sign of various forms of autoimmmune arthritis. Whipple's disease and localized T.whipplei joint infection should be considered in the diagnostic work-up of refractory arthritis. Synovial fluid analysis by means of specific polymerase chain reaction-based testing for T.whipplei is diagnostically ground-breaking.

A Theory of Diagnostic Testing to Stop the Virus Spreading: Evidence-based Reasoning to Resolve the COVID-19 Crisis by Testing.

In this study, the complicated reasoning and processes inherent in diagnostic testing were analyzed, and a mathematical theory was developed for effectively stopping the transmission of infection in the context of coronavirus disease 2019 (COVID-19). As a result of this work, a new formula was developed for the "boundary condition for contagion containment," which, based on a horizontal transmission model, gives the lower limit of sensitivity for a diagnostic test to stop the virus spreading. Two parameters are considered in the model: the level of transmission and the effective reproduction number. In example computations, the formula indicated that a one-off polymerase chain reaction-based test with a sensitivity of 85% would not be sufficient to contain highly contagious infections such as the Delta variant of SARS-CoV-2, which would likely require a sensitivity close to 100% for its containment. Furthermore, a cascade judgment system for multiple tests was proposed and examined as a form of triplet test system. This approach can enhance the accuracy of COVID-19 testing up to the minimum level needed to stop the virus spreading. The theory developed in this study will not only contribute as an academic exercise, but also be useful for making evidence-based decisions on public policy for pandemic control.

The IMproving Primary Screening And Colposcopy Triage trial: human papillomavirus, cervical cytology, and histopathologic results from the baseline and 1-year follow-up phase

An increase in human papillomavirus test volumes is expected in the near future because human papillomavirus-based screening protocols are expected to become more widely adopted. The IMproving Primary Screening And Colposcopy Triage trial, a prospective, multicenter, US-based cervical cancer screening trial, was conducted to obtain US Food and Drug Administration approvals for the new, high-throughput cobas human papillomavirus (cobas HPV) test for use on the cobas 6800/8800 Systems (cobas HPV) for detecting cervical precancerous and cancerous cells (cervical intraepithelial neoplasia of grade 2 or worse and grade 3 or worse). Here, the baseline demographics, human papillomavirus test results, cervical cytology, and histopathologic results are presented. In addition, the baseline and 1-year risks of cervical intraepithelial neoplasia grade 2 or worse and grade 3 or worse associated with the human papillomavirus results are reported. In total, 35,263 women aged between 25 and 65 years undergoing routine screening were enrolled; liquid-based cytology and 2 polymerase chain reaction-based tests for high-risk human papillomavirus were performed. Women with abnormal Papanicolaou cytology, women positive for high-risk human papillomavirus by either of the 2 human papillomavirus tests, and a random subset of women negative according to the Papanicolaou cytology and the 2 human papillomavirus tests were referred for a colposcopy and cervical biopsy. Women who did not meet the study endpoint were eligible for the 1-year follow-up study phase. Verification bias-adjusted cervical disease prevalence and risks and 95% confidence intervals were computed. The prevalence of atypical squamous cells of undetermined significance and worse than atypical squamous cells of undetermined significance cytology were 6.5% and 3.2%, respectively. Prevalence of high-risk human papillomavirus, human papillomavirus 16, and human papillomavirus 18 based on the new cobas HPV test were 15.1%, 3.1%, and 1.4%, respectively. Both cytologic abnormalities and human papillomavirus positivity declined with increasing age. Among women who had a colposcopy and biopsy, the prevalence of cervical intraepithelial neoplasia grade 2 or worse and grade 3 or worse were 8.8% and 3.6%, respectively. The baseline and 1-year cumulative risks for cervical intraepithelial neoplasia grade 3 or worse were 13.6% and 16.9%, respectively, among women who tested positive for human papillomavirus 16. Women who tested negative for human papillomavirus had the lowest 1-year cumulative risk for cervical intraepithelial neoplasia grade 3 or worse (0.06%). The contemporary, age-specific prevalence of human papillomaviruses (including human papillomavirus 16 and 18), cytologic abnormalities, and cervical intraepithelial neoplasia in a large, US-based cervical cancer screening population provides benchmarks for healthcare policies, screening programs, and for laboratories and clinicians.

Polymerase chain reaction-based tests for detecting Helicobacter pylori clarithromycin resistance in stool samples: A meta-analysis.

BACKGROUND Helicobacter pylori (H. pylori) infection is closely associated with the etiology of a variety of gastric diseases. The effective eradication of H. pylori infection has been shown to reduce the incidence of gastric carcinoma. However, the rate of H. pylori eradication has significantly declined due to its increasing resistance to antibiotics, especially to clarithromycin. Therefore, the detection of clarithromycin resistance is necessary prior to the treatment of H. pylori. Although many studies have been conducted on the use of polymerase chain reaction (PCR)-based tests to detect clarithromycin resistance in stool samples, no accurate data on the feasibility of these tests are available. Here, we performed a meta-analysis to assess the feasibility of these noninvasive tests.AIMTo evaluate the reliability of PCR-based tests for detecting H. pylori clarithromycin resistance in stool samples.METHODSWe searched PubMed, Medline, Embase, and other databases for articles that evaluated the value of the PCR analysis of stool samples for detecting the resistance of H. pylori to clarithromycin. We collected cross-sectional studies that met the inclusion criteria. Diagnostic accuracy measures were pooled using a random-effects model. The risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Subgroup analysis was also conducted according to PCR type, purification technique, reference standard, mutation site, sample weight, number of patients, and age group, and the clinical utility of diagnostic tests was evaluated using the Likelihood Ratio Scatter Graph.RESULTSOut of the 1818 identified studies, only 11 met the eligibility criteria, with a total of 592 patients assessed. A meta-analysis of the random-effect model showed that PCR-based analysis of stool samples had high diagnostic accuracy for detecting clarithromycin resistance in patients infected with H. pylori. The combined sensitivity was 0.91 [95% confidence interval (CI): 0.83-0.95], Q = 30.34, and I2 = 67.04, and the combined specificity was 0.97 (95%CI: 0.62-1.00), Q = 279.54, and I2 = 96.42. The likelihood ratio for a positive test was 33.25 (95%CI: 1.69-652.77), and that for a negative test was 0.10 (95%CI: 0.05-0.18), with an area under the curve of 0.94. The diagnostic odds ratio was 347.68 (95%CI: 17.29-6991.26). There was significant statistical heterogeneity, and the sub-analyses showed significant differences in the number of patients, sample weight, purification methods, PCR types, mutation points, and reference standards. The included studies showed no risk of publication bias.CONCLUSIONPCR-based tests on stool samples have high diagnostic accuracy for detecting H. pylori clarithromycin resistance.

Homelessness, sex and a tale of two sexually transmitted infections.

The Young People's Health Service (YPHS) is a free, nurse-led Primary Health Care Clinic, in Melbourne, for young people aged 12-24 who are experiencing homelessness. Sexually transmitted infection (STI) screening is routinely offered as part of comprehensive psychosocial assessments. We wanted to determine the number of people positive for Chlamydia trachomatis (Ct) and Mycoplasma genitalium (Mg), amongst this asymptomatic high-risk population. We also wanted to review our screening practice. All asymptomatic sexually active clients seen by YPHS between 2014 and 2016 were offered a first pass urine polymerase chain reaction-based test for Ct and Mg. Urine samples were taken for men and women. Positivity for Ct and Mg out of those tested was determined and association with gender examined. Between 2014-2016, 272 males and 278 females (n = 550) were screened for Ct, and 72 infections were detected (13.1%. Chlamydia positivity did not differ between males (n = 35; 12.9%, 95% confidence interval [CI]: 8.8-16.8) and females (n = 37; 13.3%, 95%CI: 9.3-17.3). Over the same period 273 males and 284 females were screened for Mg (n = 557) and 55 infections were detected (9.9%). A higher proportion of females (n = 35; 12.3%, 95%CI: 8.5-16.1) tested positive compared to males (n = 20; 7.3%, 95%CI: 4.2-10.4), p = 0.048. Our study demonstrates both Ct and Mg are prevalent in the population, Mg being more common in young women than young men. Referral for specialist care for macrolide-resistant Mg increased and the updated Australian STI management guidelines led to a review of practice.

High Prevalence of Sexually Transmitted Infections in Pregnant Women Living in Southern Brazil.

Porto Alegre, Brazil, has the highest rates of congenital syphilis and HIV in the country. Other treatable sexually transmitted infections (STIs) are associated with poor pregnancy and neonatal outcomes, but are only diagnosed by syndromic algorithms. Between September 2018 and November 2019, we offered all pregnant women clinic-based STI testing for HIV antibody and treponemal antibody (via lateral flow assay rapid tests provided by the Brazilian Government) and for Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis (via polymerase chain reaction-based testing provided by Gene Xpert, Sunnyvale, CA) in 10 public prenatal health clinics in Porto Alegre. Participating women answered a brief survey via audio computer-assisted survey instrument regarding demographics, partnerships, and sexual behaviors. All infected individuals received appropriate treatment and referrals. Of 400 pregnant women recruited, 94 (24%) were diagnosed with an STI, including 2% with HIV, 11% with syphilis, 9% with chlamydia, 1% with gonorrhea, 5% with trichomoniasis, and 3% with more than 1 STI. In our multivariate analysis, younger age (adjusted odds ratio [AOR], 1.1; 95% confidence interval [CI], 1-1.2), being non-White (AOR, 1.8; 95% CI, 1.1-3.1), having less education (AOR, 2; 95% CI, 1.2-3.4), and having a relationship <1 year (AOR, 2; 95% CI, 1.1-3.6) were all independent predictors of women having an STI. Endorsing symptoms of an STI (e.g., vaginal ulcers/lesions and vaginal discharge) was not predictive of having a laboratory-diagnosed STI (OR, 1.1; 95% CI, 0.7-1.7). Etiologic-based screening for STIs was uniformly accepted by women attending both hospital-based and primary health clinics in the south of Brazil and can result in appropriate treatment of pregnant women.

Use of genetic testing for hypolactasia trait in the North Denmark Region

Objective Lactose intolerance (LI) may be considered in patients with unspecific gastrointestinal symptoms, but there is no clear consensus on when and how to diagnose the disorder. The LCT-13910 CC genotype is associated with acquired primary lactase deficiency (adult-type hypolactasia; ATH). We aimed to describe the number of tests and test results in the North Denmark Region considering patient age, geographical origin and repeated testing. Methods Retrospective evaluation of the polymerase chain reaction-based LCT-13910 genotype tests registered in the clinical laboratory information system (LABKA II) with data linkage to Danish nationwide registers. Results Between 18 May 2007 and 31 December 2018, a total of 23,560 individuals were tested. There was a sevenfold increase in the number of tests performed during the study period. About 9.8% of the tests performed in 2018 were repeated testing in the same individuals. Overall, 8.8% of tested individuals were younger than 5 years, 90.7% were of Danish origin and 5.5% originated from outside of Europe. The LCT-13910 CC genotype was identified in 13.3% of all tested individuals, in 16.0% of children younger than 5 years, in 6.8% of Danish individuals and in 90.9% originating from outside of Europe. Conclusions In the North Denmark Region, a marked increase in the use of genetic testing for hypolactasia was observed and repeated testing was frequent. Furthermore, the use of the test and the test results were dependent on patient age and geographical origin. Results inform the debate on when and how to use genetic testing in the diagnosing of LI.

Solid organ transplantation programs facing lack of empiric evidence in the COVID-19 pandemic: A By-proxy Society Recommendation Consensus approach.

The ongoing severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) pandemic has a drastic impact on national health care systems. Given the overwhelming demand on facility capacity, the impact on all health care sectors has to be addressed. Solid organ transplantation represents a field with a high demand on staff, intensive care units, and follow‐up facilities. The great therapeutic value of organ transplantation has to be weighed against mandatory constraints of health care capacities. In addition, the management of immunosuppressed recipients has to be reassessed during the ongoing coronavirus disease 2019 (COVID‐19) pandemic. In addressing these crucial questions, transplant physicians are facing a total lack of scientific evidence. Therefore, the aim of this study was to offer an approach of consensus‐based guidance, derived from individual information of 22 transplant societies. Key recommendations were extracted and the degree of consensus among different organizations was calculated. A high degree of consensus was found for temporarily suspending nonurgent transplant procedures and living donation programs. Systematic polymerase chain reaction‐based testing of donors and recipients was broadly recommended. Additionally, more specific aspects (eg, screening of surgical explant teams and restricted use of marginal donor organs) were included in our analysis. This study offers a novel approach to informed guidance for health care management when a priori no scientific evidence is available.

Significance of HPV16 Viral Load Testing in Anal Cancer

Human papilloma virus (HPV) is highly frequent among patients with anal squamous cell carcinoma, but the viral load (VL) differs between patients. This study aimed to compare the rate of HPV positivity, HPV16VL, p16INK4A and p53 expression between treatment naive and recurrent anal cancer patients. HPV was genotyped via AmpliSens® HPV HCR-genotype-titre-FRT kit. HPV16 VL was determined via quantitative polymerase chain reaction-based in-house test. p16INK4A and p53 expression was tested via immunohistochemistry. The cohort comprised 13 treatment-naive and 17 recurrent anal SCC patients. High-risk HPV was detected in 87% of cases, and HPV16 (73%) was the predominant genotype. The rate of HPV positivity was higher among women and nonsmokers, and majority of HPV-positive cases were also p16INK4A-positive. All p53-negative tumors were HPV16-positive. The most predominant p53 staining pattern in the HPV-positive group was scattered type, whereas it was diffuse type in the HPV-negative group. The HPV16 VL was higher in the treatment-naive group. Further, in the treatment-naive group, cases with scattered staining pattern of p53 had higher HPV16 VL than cases with diffuse staining pattern. The opposite result was noted in the recurrent cancer group. Moreover, p16-positive cases with scattered p53 staining pattern in the treatment naive group had higher HPV16 VL than their counterparts in the recurrent cancer group. In conclusion, the HPV VL, as is the association between VL and p16INK4A /p53, is in an inversed trend in treatment naive and recurrent cancer patients, highlighting the importance of HPV VL measurement in anal SCC.