Rapid Point Of Care Test Research Articles

What to consider when reopening clinics following the COVID-19 pandemic

Journal of Aesthetic NursingVol. 9, No. 10 Practice ManagementWhat to consider when reopening clinics following the COVID-19 pandemicManav BawaManav BawaE: E-mail Address: [email protected]Medical director, Time Clinic, LondonSearch for more papers by this authorManav BawaPublished Online:9 Dec 2020https://doi.org/10.12968/joan.2020.9.10.457AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article References Adams JG, Walls RM. Supporting the health care workforce during the COVID-19 global epidemic. 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Immune Response in COVID-19: Sero-Diagnostic Evidence for Clinical use and Research

Serological markers have remained the mainstay of infectious disease diagnosis and treatment monitoring for last so many decades. The comfort associated with serology testing has emerged from end user understanding, availability of “Rapid Point of Care testing (POCT)” formats and most importantly decreased turnaround times (TAT). In recent times, COVID-19 has burdened the healthcare systems across the globe. Rapid and accurate diagnosis is imperative to contain this contagion in the context of case detection, contact tracing, quarantine, admissions, therapeutic assessment for convalescent sera administration and epidemiological surveys for herd immunity. Nucleic Acid Tests (NAT) evolved as an accurate and early diagnostic modality and is currently considered as the standard in SARS-CoV-2 diagnosis. Though sensitive enough to pick up early disease, NAT testing is limited by false negative results in later half of the infection cycle along issues like higher cost, need for sophisticated equipment, skilled laboratory workers and oversight by pathologist thus hindering use on mass-scale. Serological diagnostic strategies, if used rationally may be a potentially cost-effective option for resource limited settings along with additional benefits for defining immune status and epidemiological surveys. This mini-review attempts to discuss and consolidate data on available and candidate serological markers including various antibodies (IgM, IgG and IgA), and antigen tests to guide clinical practitioners and researchers.

AnemoCheck-LRS: an optimized, color-based point-of-care test to identify severe anemia in limited-resource settings

BackgroundSevere anemia is common and frequently fatal for hospitalized patients in limited-resource settings. Lack of access to low-cost, accurate, and rapid diagnosis of anemia impedes the delivery of life-saving care and appropriate use of the limited blood supply. The WHO Haemoglobin Colour Scale (HCS) is a simple low-cost test but frequently inaccurate. AnemoCheck-LRS (limited-resource settings) is a rapid, inexpensive, color-based point-of-care (POC) test optimized to diagnose severe anemia.MethodsDeidentified whole blood samples were diluted with plasma to create variable hemoglobin (Hb) concentrations, with most in the severe (≤ 7 g/dL) or profound (≤ 5 g/dL) anemia range. Each sample was tested with AnemoCheck-LRS and WHO HCS independently by three readers and compared to Hb measured by an electronic POC test (HemoCue 201+) and commercial hematology analyzer.ResultsFor 570 evaluations within the limits of detection of AnemoCheck-LRS (Hb ≤ 8 g/dL), the average difference between AnemoCheck-LRS and measured Hb was 0.5 ± 0.4 g/dL. In contrast, the WHO HCS overestimated Hb with an absolute difference of 4.9 ± 1.3 g/dL for samples within its detection range (Hb 4–14 g/dL, n = 405). AnemoCheck-LRS was much more sensitive (92%) for the diagnosis of profound anemia than WHO HCS (22%).ConclusionsAnemoCheck-LRS is a rapid, inexpensive, and accurate POC test for anemia. AnemoCheck-LRS is more accurate than WHO HCS for detection of low Hb levels, severe anemia that may require blood transfusion. AnemoCheck-LRS should be tested prospectively in limited-resource settings where severe anemia is common, to determine its utility as a screening tool to identify patients who may require transfusion.

Point-of-Care Influenza Testing Impacts Clinical Decision, Patient Flow, and Length of Stay in Hospitalized Adults.

BackgroundInfluenza is difficult to distinguish clinically from other acute respiratory infections. Rapid laboratory diagnosis can help initiate early effective antiviral treatment and isolation. Implementing a novel point-of-care test (POCT) for influenza in the emergency department (ED) could improve treatment and isolation strategies and reduce the length of stay (LOS).MethodsIn a prospective, controlled observational cohort study, we enrolled patients admitted due to acute respiratory illness to 2 public hospitals in Bergen, Norway, one using a rapid POCT for influenza (n = 400), the other (n = 167) using conventional rapid laboratory-based assay.ResultsPrevalence of influenza was similar in the 2 hospitals (154/400, 38% vs 38%, 63/167; P = .863). Most patients in both hospitals received antiviral (83% vs 81%; P = .703) and antibiotic treatment (72% vs 62%; P = .149). Isolation was more often initiated in ED in the hospital using POCT (91% vs 80%; P = .025). Diagnosis by POCT was associated with shorter hospital stay; old age, diabetes, cancer, and use of antibiotics, particularly broad-spectrum antibiotics, were associated with prolonged stay.ConclusionsPOCT implementation in ED resulted in improved targeted isolation and shorter LOS. Regardless of POCT use, most influenza patients received antivirals (>80%) and antibiotics (>69%).

Highly Specific Monoclonal Antibodies Against SARS-CoV-2 Nucleocapsid Antigen for Accurate Diagnosis of COVID-19

The ongoing COVID-19 pandemic is a major global public health concern. Although rapid point of care testing for detecting viral antigen is important for management the outbreak, none of current antigen detection kits provide a reliable diagnosis due to the lack of a specific monoclonal antibody (mAb) against SARS-CoV-2. In our current study, we produced mAbs exclusively react with SARS-CoV-2 and exhibited no cross-reactivity with other human coronaviruses including SARS-CoV. Molecular modeling revealed that the mAbs bound to epitopes present on the exterior surface of the nucleocapsid, encompassing their scope for detecting SARS-CoV-2 in clinical samples. We further selected the optimal pair of anti-SARS-CoV-2 NP mAbs for designing ELISA and immunochromatographic assay. An integrated bioinformatics analysis revealed that our mAbs could comprehensively detect divergent strains of SARS-CoV-2. Due to the high redundancy and absence of cross-reactivity, our newly developed mAbs would be instrumental for developing reliable diagnosis kits for COVID-19.Funding: This work was supported in part by Japan Agency for Medical Research and Development (AMED, Grant number: JP19fk0108110 and JP20he0522001), and by Health Labour Sciences research grant from The Ministry of Health Labour and Welfare.Conflict of Interest: The authors have no conflicts of interest directly relevant to the content of this article. YY, SK, KS and DA is a current employee of Kanto Chemical Co., Inc.Ethical Approval: This study was approved by the Institutional Review Board of Yokohama City University (IRB No. B200800106), and the protocols used in the study were approved by the ethicscommittee.

Assessing a novel, lab-free, point-of-care test for SARS-CoV-2 (CovidNudge): a diagnostic accuracy study

BackgroundAccess to rapid diagnosis is key to the control and management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Laboratory RT-PCR testing is the current standard of care but usually requires a centralised laboratory and significant infrastructure. We describe our diagnostic accuracy assessment of a novel, rapid point-of-care real time RT-PCR CovidNudge test, which requires no laboratory handling or sample pre-processing.MethodsBetween April and May, 2020, we obtained two nasopharyngeal swab samples from individuals in three hospitals in London and Oxford (UK). Samples were collected from three groups: self-referred health-care workers with suspected COVID-19; patients attending emergency departments with suspected COVID-19; and hospital inpatient admissions with or without suspected COVID-19. For the CovidNudge test, nasopharyngeal swabs were inserted directly into a cartridge which contains all reagents and components required for RT-PCR reactions, including multiple technical replicates of seven SARS-CoV-2 gene targets (rdrp1, rdrp2, e-gene, n-gene, n1, n2 and n3) and human ribonuclease P (RNaseP) as sample adequacy control. Swab samples were tested in parallel using the CovidNudge platform, and with standard laboratory RT-PCR using swabs in viral transport medium for processing in a central laboratory. The primary analysis was to compare the sensitivity and specificity of the point-of-care CovidNudge test with laboratory-based testing.FindingsWe obtained 386 paired samples: 280 (73%) from self-referred health-care workers, 15 (4%) from patients in the emergency department, and 91 (23%) hospital inpatient admissions. Of the 386 paired samples, 67 tested positive on the CovidNudge point-of-care platform and 71 with standard laboratory RT-PCR. The overall sensitivity of the point-of-care test compared with laboratory-based testing was 94% (95% CI 86–98) with an overall specificity of 100% (99–100). The sensitivity of the test varied by group (self-referred healthcare workers 94% [95% CI 85–98]; patients in the emergency department 100% [48–100]; and hospital inpatient admissions 100% [29–100]). Specificity was consistent between groups (self-referred health-care workers 100% [95% CI 98–100]; patients in the emergency department 100% [69–100]; and hospital inpatient admissions 100% [96–100]). Point of care testing performance was similar during a period of high background prevalence of laboratory positive tests (25% [95% 20–31] in April, 2020) and low prevalence (3% [95% 1–9] in inpatient screening). Amplification of viral nucleocapsid (n1, n2, and n3) and envelope protein gene (e-gene) were most sensitive for detection of spiked SARS-CoV-2 RNA.InterpretationThe CovidNudge platform was a sensitive, specific, and rapid point of care test for the presence of SARS-CoV-2 without laboratory handling or sample pre-processing. The device, which has been implemented in UK hospitals since May, 2020, could enable rapid decisions for clinical care and testing programmes.FundingNational Institute of Health Research (NIHR) Imperial Biomedical Research Centre, NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at Oxford University in partnership with Public Health England, NIHR Biomedical Research Centre Oxford, and DnaNudge.

Cost-Effectiveness Analysis of Point-of-Care Rapid Testing Versus Laboratory-Based Testing for Antenatal Screening of Syphilis in Brazil

ObjectivesSevere consequences of mother-to-child transmission of syphilis and high increasing incidence of congenital syphilis remains an important public health problem in Brazil. Our objective was to assess the cost-effectiveness of a rapid point-of-care test (RT) and treatment of positive mothers immediately compared with a laboratory-based standard test (ST) with treatment at next follow-up visit. MethodsA decision analytic model was developed to estimate the incremental cost-effectiveness ratio (ICER) between antenatal syphilis screening strategies. The model was built with lifetime horizon from Brazilian health system perspective using 3% and 5% discount rates. A hypothetical cohort of pregnant women at reproductive age were used in the model. Health outcomes: low birth weight, stillbirths, neonatal deaths and congenital syphilis were estimated in disability-adjusted life-years (DALYs) lost. Microcosting study and secondary data provided parameters of direct medical costs. Probabilistic sensitivity analysis was undertaken. ResultsFor base case, the mean cost per pregnant woman screened was $2.63 (RT) and $2.48 (ST), respectively. Maternal syphilis was associated with a loss of 0.0043 DALYs (RT) and 0.0048 DALYs (ST) per mother screened. Expected value of incremental cost per DALY averted was $298.08. After 10 000 probabilistic sensitivity analysis model runs, incremental cost and health benefits were $0.15 (95% credible interval –1.56 to 1.92) and 0.00042 DALYs (95% credible interval –0.0036 to 0.0044), respectively, with a mean ICER of $357.44 per DALY. Screening with RT has a 58% chance of being the optimal strategy at a threshold of $3,200 per DALY. ConclusionsIn Brazil, antenatal screening with syphilis RT and immediate treatment is likely to be cost-effective compared with standard screening and must be prioritized in local settings.

Fluorescent lateral flow immunoassay for highly sensitive detection of eight anticoagulant rodenticides based on cadmium-free quantum dot-encapsulated nanospheres

A method for the rapid, sensitive, and eco-friendly detection of anticoagulant rodenticides (ARs) in emergency clinics and food samples with point-of-care (POC) assay is highly demanded. The gold nanoparticles and cadmium-based quantum dots (QDs) used as probe in POC testing usually suffer from low sensitivity and high toxicity. Hence, here, we synthesized hydrophilic QDs-based polystyrene nanospheres (QNs) by encapsulating cadmium-free and oleylamine-coated InP/ZnS QDs into polystyrene nanospheres via a facile swelling-evaporation strategy. A lateral flow immunoassay (LFIA) adopted the QNs as probes was proposed to detect eight ARs, achieving quantitative limits of detection from 0.01–2.0 μg/L and visual limits of detection from 0.16–32.0 μg/L for warfarin, coumachlor, coumafuryl, bromadiolone, difenacoum, coumatetralyl, diphacinone and chlorophacinone. The accuracy and precision of the QNs-based LFIA were evaluated by ARs-spiked wheat, human serum and urine, and acceptable recoveries were obtained. The sensitivity of QNs-based LFIA was 2.5–6.25 times better than that of the gold nanoparticles-based LFIA. The QNs-based LFIA was applied to clinical human serum and showed good correlation with ultraperformance liquid chromatography-tandem mass spectrometry. In summary, the QNs-based LFIA provides a rapid, sensitive, and quantitative POC testing method of ARs for poisoning diagnosis and food analysis.

Point-of-Care Testing for Sexually Transmitted Infections: A Review of Recent Developments.

Sexually transmitted infections (STIs) are among the most common communicable diseases globally and are associated with significant morbidity and mortality worldwide. Point-of-care tests have the potential to revolutionize the prevention and control of STIs by enabling rapid diagnosis and early treatment of infections, thus interrupting transmission and preventing the sequelae of untreated infections. Currently, there are several point-of-care (POC) tests available for the diagnosis of Treponema pallidum, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections, although these tests differ with regard to their performance, turnaround time, and cost. To provide an updated review of the POC tests available and under development for the diagnosis of T pallidum, C trachomatis, N gonorrhoeae, and T vaginalis infections, to discuss the context for which these tests might be used, and to highlight future directions for test development. We reviewed the literature pertaining to the recent development and performance evaluations of POC tests for the diagnosis of syphilis, chlamydia, gonorrhea, and trichomonas. Recently, there has been rapid development of new POC tests for STIs. Although there are inexpensive, rapid, and accurate POC tests available for syphilis, there are few such tests available for the diagnosis of chlamydia, gonorrhea, or trichomonas, and currently none with the ability to detect antimicrobial resistance in N gonorrhoeae. Research evaluating implementation strategies for the currently available tests and the development of additional POC tests that are rapid, accurate, and affordable are urgently needed to address the rising number of STIs worldwide.

Reducing Read Time of Point-of-Care Test Does Not Affect Detection of Hepatitis C Virus and Reduces Need for Reflex RNA

Global elimination of hepatitis C virus (HCV) will require increases in diagnosis. Point of care (POC) tests that detect antibodies against HCV can be useful for testing large and difficult to reach populations. The most accurate POC test requires a 20 min read time to identify antibody-positive samples. We investigated whether viremic patients could be identified using a shorter read time, to increase efficiency and reduce the need for reflex tests (a follow-up test for HCV RNA on the same specimen to confirm viremia). Patients with past or current HCV infections provided samples at 2 clinics in Canada for evaluation by the OraQuick HCV Rapid antibody POC test. A community HCV-screening program in Madrid, Spain (real-world cohort) invited people to be tested for HCV with the same OraQuick test. Patients provided samples of whole blood, via finger prick. Fingerprick samples were tested immediately after collection. In the clinic cohort, photographs of the developing test were taken at 15 second intervals, and blinded readers recorded the time to positivity. In the real-world cohort, readers recorded the OraQuick result at 5 minutes, and each minute after, up to 10 minutes, and then again at 20 minutes; viremia was then evaluated using a POC HCV RNA test (GeneXpert HCV Viral Load Assay). Sera from viremic and non-viremic clinic patients were used to quantify antibody titers to investigate the relationship between the time of band appearance and antibody concentration. Fisher's exact test and exact logistic regression were used to determine factors associated with a positive result at 5 minutes. Blood from all viremic patients produced a positive result in the antibody POC test by 5 min. Median time to a positive result for 171 viremic patients was 2.6 min (range, 1.8-4.6 min), vs 4.1 min (range, 2.3-14.4 min) for 108 patients with resolved infection (P < .001). The 5-min threshold identified all viremic cases among 176 HCV antibody-positive patients in the real-world cohort, confirmed by testing for HCV RNA. In the pooled cohorts, antibody positivity at 5 min identified viremic patients with 100% sensitivity (95% CI, 98.4%-100%); the negative predictive value was 100% (95% CI, 94.9%-100%). The positive predictive value at 5 min was 62.0% (95% CI, 56.7%-67.0%) and therefore insufficient alone to detect viremia; an HCV RNA test would still be necessary to confirm active infection. The wait time for the OraQuick HCV Rapid antibody POC blood test can be reduced from 20 min to 5 min and continue to reliably identify patients with HCV infection. Shortening the test time could increase high-throughput screening, reduce loss to follow up, and reduce the need for reflex HCV RNA testing.

Call to action for health systems integration of point-of-care testing to mitigate the transmission and burden of sexually transmitted infections

ObjectivesIn 2016, WHO estimated 376 million new cases of the four main curable STIs: gonorrhoea, chlamydia, trichomoniasis and syphilis. Further, an estimated 290 million women are infected with human papillomavirus....

Cost evaluation of point-of-care testing for community-acquired influenza in adults presenting to the emergency department.

Rapid molecular point-of-care tests (POCTs) for influenza have potential to produce cost savings in emergency departments (EDs) and acute care settings. To date, published projected savings have been based on estimated costs. This study aimed to describe the cost implications of a rapid influenza POCT using accurate real-world patient level costing data. 204 adult patients receiving point-of-care (POC) influenza testing in the ED as part of a routine clinical service were identified retrospectively, alongside a control cohort of 104 patients from the same influenza season. Costs for all were calculated at the individual patient level. Cost comparison was performed using an instrumental variable (IV) regression to overcome potential bias within the observational dataset. Patients who had a POCT on average cost 67 % less than those who did not (average cost reduction: £2066: 95 % CI: £624 and £2665). Moderate to high NEWS score at arrival, presence of ≥1 comorbidity, and age ≥70 years increased overall costs across both groups (p < 0.05). Savings from POC testing can be attributed to more targeted treatments, fewer admissions and reduced lengths of stay. The IV regression results are supported by a second method (ordinary least square against baseline characteristics). They are also in line with existing work that use estimated costs but indicate greater savings than predicted previously. In conclusion, POC influenza testing in the emergency department produces significant cost savings, this is demonstrated here through an analysis using individual real-world patient level costing data.

Rapid Point of Care Test for Detecting Urogenital Chlamydia Trachomatis Infection in Nonpregnant Women and Men at Reproductive Age

(Abstracted from Cochrane Database Syst Rev 2020;1(1):CD011708) Chlamydia trachomatis is associated with deleterious effects on the reproductive health of men and women. Its estimated prevalence is 90 million cases worldwide and is highest among the sexually active population 25 years or younger.

Rapid POC tests have low sensitivity for C trachomatis in nonpregnant women or men of reproductive age.

Grillo-Ardila CF, Torres M, Gaitan HG. Rapid point of care test for detecting urogenital Chlamydia trachomatis infection in nonpregnant women and men at reproductive age. Cochrane Database Syst Rev. 2020;1:CD011708. 31995238.

Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2

We aimed to evaluate the role of rapid serological tests in the management of coronavirus disease 2019 (COVID-19) patients. This retrospective study enrolled 16 real-time reverse transcription polymerase chain reaction-confirmed symptomatic patients with COVID-19 and 58 COVID-19 negative patients at a medical center in Taiwan over a 3-month period. Serial serum samples were collected and tested for antibody response using four point-of-care (POC) lateral flow immunoassays (LFIA) (ALLTEST 2019-nCoV IgG/IgM Rapid Test, Dynamiker 2019-nCoV IgG/IgM Rapid Test, ASK COVID-19 IgG/IgM Rapid Test, and Wondfo SARS-CoV-2 Antibody Test). Time-dependent detection sensitivity and timeliness of seroconversion were determined and compared between the four POC rapid tests. The overall sensitivity and specificity of the four tests for detecting anti-SARS-CoV-2 antibodies after 3 weeks of symptom onset were 100% and 100%, respectively. There was no significant difference between the rapid tests used for detection of IgM and IgG separately and those used for detection of combined total antibody (mainly IgM/IgG). There was no significant difference between the four POC rapid tests in terms of time required for determining seroconversion of COVID-19. Patients with COVID-19 with pneumonia demonstrated shorter seroconversion time than those without pneumonia. Though the POC antibody rapid tests based on LFIA showed reliable performance in the detection of SARS-CoV-2-specific antibodies, the results of these tests should be interpreted and applied appropriately in the context of antibody dynamic of COVID-19 infection. COVID-19 patients complicated with pneumonia exhibited earlier anti-SARS-CoV-2 antibody response than COVID-19 patients without pneumonia.

What is the accuracy of rapid point of care tests for detecting urogenital Chlamydia trachomatis infection in nonpregnant women and men at reproductive age?

What is the accuracy of rapid point of care tests for detecting urogenital Chlamydia trachomatis infection in nonpregnant women and men at reproductive age?

Point of care testing of Influenza A/B and RSV in an adult respiratory assessment unit is associated with improvement in isolation practices and reduction in hospital length of stay.

Introduction. Every winter seasonal influenza and other viral respiratory infections increase pressure on the health services and are associated with nosocomial infection and morbidity.Aim. To compare provision of point-of-care (POC) testing with laboratory-based testing for influenza and RSV detection on an adult respiratory assessment unit to assess the impact on isolation practices and length of stay (LOS).Methodology. Prospective interrupted ‘on-off’ study in adults admitted to the respiratory unit between December 2018 and April 2019 with a suspected respiratory tract infection. Nasopharyngeal samples were tested using either the GeneXpert rapid POC test for influenza and RSV (on-period), or were sent to the laboratory for multiplex PCR testing against a panel of 12 respiratory viruses (off-period). Outcome measures were time to patient isolation for infection control, LOS and turnaround time from admission to test results.Results. Of 1145 patients evaluated, 755 were tested with POC and 390 with laboratory multiplex; a respiratory virus was identified in 164 (21.7 %) and 138 (35.4 %) patients respectively. A positive POC test was associated with a shorter time to isolation (mean difference 16.9 h, P<0.001), shorter LOS (mean difference 15.5 h, P=0.05,) and shorter turnaround time (mean difference 28.3 h, P<0.001), compared to laboratory testing.Conclusion. Use of GeneXpert POC testing for Flu/RSV is associated with rapid reporting of results with significant improvements in isolation practices and reductions in LOS.

Highly sensitive vertical flow based point-of-care immunokit for rapid and early detection of human CRP as a cardiovascular risk factor.

Early detection and treatment of cardiovascular disease by identifying markers is important to improve the health of our citizens and simultaneously reduce the cost of health care. Therefore, there is an urgent need for early detection and treatment of asymptomatic cardiovascular disease. Herein, we have developed highly sensitive vertical flow immunokit (VFIK) for the detection of C-reactive protein (CRP), comprising an antibody/citrate conjugated gold nanoparticle in a fixed orientation surface. Our CRP test kit has been optimized with various parameters such as buffer composition, the quantity of captured antibody and sensitivity of the assay. Prominently, our developed CRP test kit is highly sensitive and rapid point of care test (POCT) which is capable to detect CRP with minimal volume (50-60μl) and time (1-2min) with diminutive detection up to 10ng/ml. The reliability of our kit was evaluated and validated with spiked and clinical whole blood samples. The results demonstrated that our developed vertical flow-based point-of-care Immunokit may serve fruitful and semi-quantitative routine diagnostic for the early detection of cardiac disease.

Maternal serum glycosylated fibronectin as a short-term predictor of preeclampsia: a prospective cohort study

BackgroundPreeclampsia is a major pregnancy complication that results in significant maternal and infant mortality, most of which occurs in low and middle-income countries. The accurate and timely diagnosis of preeclampsia is critical in management of affected pregnancies to reduce maternal and fetal/neonatal morbidity and mortality, yet difficulties remain in establishing the rigorous diagnosis of preeclampsia based on clinical parameters alone. Biomarkers that detect biochemical disease have been proposed as complements or alternatives to clinical criteria to improve diagnostic accuracy. This cohort study assessed the performance of several biomarkers, including glycosylated fibronectin (GlyFn), to rule-in or rule-out preeclampsia within 4 weeks in a cohort of women at increased risk for preeclampsia.Methods151 women with risk factors for or clinical signs and symptoms of preeclampsia were selected from a prospective cohort. Maternal serum samples were collected between 20 and 37 weeks of gestation. Clinical suspicion of preeclampsia was defined as presence of new-onset proteinuria, or clinical symptoms of preeclampsia. Subjects with a clinical diagnosis of preeclampsia at the time of enrollment were excluded. GlyFn, pregnancy-associated plasma protein-A2 (PAPPA2), placental growth factor (PlGF), and soluble fms-like tyrosine kinase-1 (sFlt-1) were measured by immunoassay. GlyFn was also determined using a rapid point-of care (POC) test format. Receiver-operating characteristic (ROC) curves derived from logistic regression analysis were used to determine the classification performance for each analyte.Results32 of 151 (21%) women developed a clinical diagnosis of preeclampsia within 4 weeks. All biomarkers exhibited good classification performance [GlyFn (area under the curve (AUROC) = 0.94, 91% sensitivity, 86% specificity); PAPPA2 AUC = 0.92, 87% sensitivity, 77% specificity; PlGF AUC = 0.90, 81% sensitivity, 83% specificity; sFlt-1 AUC = 0.92, 84% sensitivity, 91% specificity. The GlyFn immunoassay and the rapid POC test showed a correlation of r = 0.966.ConclusionsIn this prospective cohort, serum biomarkers of biochemical disease were effective in short-term prediction of preeclampsia, and the performance of GlyFn in particular as a POC test may meet the needs of rapid and accurate triage and intervention.

Rapid point of care test for detecting urogenital Chlamydia trachomatis infection in nonpregnant women and men at reproductive age.

Chlamydia trachomatis (C trachomatis) is one of the most frequent sexually transmitted infections and a source of deleterious effects on the reproductive health of men and women. Because this infection is likely asymptomatic and is associated with subfertility, ectopic pregnancy, and chronic pain, its presence needs to be confirmed. Technologies available for the diagnosis of C trachomatis infection can be classified into tests performed in a laboratory and rapid tests at the point of care (POC tests). Laboratory-based tests include culture, nucleic acid amplification tests, enzyme immunoassays (EIA), direct fluorescent antibody, nucleic acid hybridization, and transformation tests. Rapid tests include solid-phase EIA and solid-phase optical immunoassay. POC tests can be performed within 30 minutes without the need for expensive or sophisticated equipment. The principal advantage of this technology is the immediate presentation of results with the subsequent possibility to start the treatment of infected patients immediately. To determine the diagnostic accuracy of rapid point-of-care (POC) testing for detecting urogenital C trachomatis infection in nonpregnant women and men of reproductive age, as verified with nucleic acid amplification tests (NAATs) as the reference standard. In November 2019 we searched CENTRAL, MEDLINE, Embase and LILACS. We also searched Web of Science, two trials registries and an abstract database. We screened reference lists of included studies for additional references. We included diagnostic accuracy studies of symptomatic or asymptomatic nonpregnant women and men reproductive age. Included trials should have prospectively enrolled participants without previous diagnostic testing, co-infections or complications and consecutively or through random sampling at primary or secondary care facilities. Only studies reporting that all participants received the index test and the reference standard and presenting 2 x 2 data were eligible for inclusion. We excluded diagnostic case-control studies. Two review authors independently screened titles and abstracts for relevance. Two review authors independently, and in duplicate, assessed eligibility, extracted data, and carried out quality assessment. We resolved differences through consensus or by involving a third review author. We assessed studies for methodological quality using QUADAS-2 and used meta-analysis to combine the results of studies using the bivariate approach to estimate the expected sensitivity and specificity values. We assessed the quality of the evidence using GRADE criteria and explored sources of heterogeneity. We included a total of 19 studies, with 13,676 participants, that assessed the diagnostic accuracy of POC tests for C trachomatis infection in nonpregnant women and men of reproductive age, as verified with NAATs as the reference standard. Rapid tests were provided by the distributors in nine studies. Seven studies recruited a predominantly high risk or symptomatic population; the studies were conducted in America, Asia, Africa, Europe and Oceania, with a median prevalence of 10% (range 8% to 28%); nine different brands were assessed. The mean sensitivity for rapid tests for detecting urogenital infection was 0.48 (95% confidence interval (CI) 0.39 to 0.58; low-quality evidence) with a mean specificity of 0.98 (95% CI 0.97 to 0.99; moderate-quality evidence). We explored sources of heterogeneity by looking into differences in diagnostic accuracy according to the specimen (endocervical versus urine or vaginal), symptoms among participants (symptomatic versus asymptomatic), and setting (low/middle-income versus high-income countries). Likelihood ratio tests were not significantly different in terms of sensitivity or specificity by specimen (P = 0.27) or setting (P = 0.28); for this reason, these covariates do not appear to explain the observed variability. Included studies did not provide enough information to assess the 'presence of symptoms' covariate. We downgraded the quality of evidence because of some limitations in applicability and heterogeneity. Based on the results of this systematic review, the POC test based on antigen detection has suboptimal sensitivity but good specificity. Performance of this test translates, on average, to a 52% chance of mistakenly indicating absence of infection and a 2% chance of mistakenly pointing to the presence of this condition. Because of its deleterious consequences for reproductive health, and considering the current availability of safe and effective interventions to treat C trachomatis infection, the POC screening strategy should not be based on a rapid diagnostic test for antigen detection. Research in this topic should focus on different technologies.