Gold Standard Examination Research Articles

Partially purified Strongyloides ratti antigen improved the diagnostic performance of strongyloidiasis by enzyme-linked immunosorbent assay (ELISA) and immunochromatographic test (ICT).

Strongyloides stercoralis infection is a neglected tropical disease with a global distribution. Serodiagnosis is a sensitive method, but improving its performance and simplifying into a point-of-care test (POCT) are needed. This study aimed to improve the diagnostic performance of serological tests using partially purified Strongyloides ratti antigen in an enzyme-linked immunosorbent assay (ELISA) and an immunochromatographic test (ICT). Crude S. ratti antigen was purified by an IgG affinity column to partition the antigen into flow-through, washing fraction (WF), and elution fractions. Optimized ELISA and ICT using crude and antigen fractions were used to analyze sera from three groups of subjects. Group 1 comprised subjects with proven strongyloidiasis, Group 2 were subjects with other parasitic infections, and Group 3 were negative parasitic infections. The diagnostic performance and Kappa agreement of the serological tests were analyzed and compared, using larvae detection as the reference test (fecal examination). The results showed that the WF was the most efficient antigen in terms of sensitivity and specificity, as determined by the ELISA and ICT. Kappa's agreement between fecal examination and WF-ELISA was moderate (Kappa = 0.52), and WF-ICT was almost perfect (Kappa = 0.94). The WF antigen reduced cross-reactivity to other parasitic infections, that is, Opisthorchis viverrini, Taenia spp., and hookworms, compared to crude S. ratti antigen when assessed by ELISA and ICT. We concluded that the WF of purified S. ratti improved the ELISA and ICT diagnostic performance, and the latter assay format could be used as a POCT for screening and controlling strongyloidiasis.IMPORTANCEThis study aimed to improve the serological diagnosis of strongyloidiasis, a disease caused by infection with the intestinal nematode Strongyloides stercoralis, by evaluating the impact of Strongyloides ratti antigen purification using an IgG affinity column for detecting parasite-specific IgG in serum via enzyme-linked immunosorbent assay (ELISA) and immunochromatographic test (ICT) formats. Compared to crude S. ratti antigen, the washing fraction (WF) of the purified antigen demonstrated significantly improved sensitivity and specificity in both ELISA and ICT, achieving strong diagnostic concordance with the gold-standard fecal examination. Furthermore, the WF antigen fraction exhibited reduced cross-reactivity with coinfections caused by the liver fluke (Opisthorchis viverrini), tapeworms (Taenia spp.), and hookworms. These findings underscore antigen purification as a promising strategy to enhance the accuracy of strongyloidiasis serodiagnosis.

Efficacy of 4-dimensional hysterosalpingo-contrast sonography and X-ray hysterosalpingography in infertility.

To assess and compare efficacy of 4-dimensional hysterosalpingo-contrast sonography (4D-HyCoSy) and X-ray hysterosalpingography (HSG) for fallopian tube examination. Clinical data of patients with suspected tubal infertility, who underwent examinations in Qingdao Women and Children's Hospital from September 2021 to December 2023, were retrospectively analyzed. Of them, 40 patients received laparoscopy and dye test+ 4D-HyCoSy (4D-HyCoSy group), and 36 patients received laparoscopy and dye test +HSG (HSG group). The study included clinical data of 76 patients with a total of 149 fallopian tubes. Using laparoscopy and dye test observations as the gold standard, 4D-HyCoSy and X-HSG examinations identified 39 blocked tubes, 69 tubes with partial patency, and 41 tubes with patency. Compared with laparoscopy and dye test, the diagnostic concordance rate of 4D-HyCoSy was 70.51% (55/78), Kappa=0.546 (P<0.05); and the diagnostic concordance rate of HSG was 69.01% (49/71), Kappa=0.516 (P<0.05). Sensitivity, specificity, and accuracy of the diagnosis of obstruction, partial patency, and patency were comparable in the two groups (P>0.05). The incidence of pain and adverse reactions were significantly lower in the 4D-HyCoSy group compared to the HSG group (P<0.05). While both 4D-HyCoSy and HSG have high efficacy in fallopian tube examination, and are similarly accurate in evaluating tubal blockage, 4D-HyCoSy is associated with lower incidence of pain, and reduced rate of adverse reactions.

Differences in Serum Creatinine Levels in Controlled and Uncontrolled Type 2 Diabetes Mellitus Patients

Diabetes Mellitus is in the top 10 causes of death in the world. Indonesia ranks 5th out of 10 countries in the number of diabetes mellitus sufferers in adults aged 20-79 years. Type 2 Diabetes Mellitus is the most common type of Diabetes Mellitus. Examination of the HbA1c value is the gold standard examination for Type 2 Diabetes Mellitus. In PERKENI 2021, the risk of suffering from Type 2 Diabetes Mellitus increases with increasing age and it is recommended to screen for Type 2 Diabetes Mellitus at the age of &gt; 40 years. The second most common complication of Diabetes Mellitus in Indonesia is nephropathy. Diabetic nephropathy is the main cause of end-stage renal failure which is the 5th stage of chronic renal failure. Examination of creatinine in the blood is an important parameter to determine kidney function. The aim of this study was to determine the average difference between serum creatinine levels in controlled and uncontrolled type 2 diabetes mellitus. This research was an analytical observational study with a cross-sectional design using secondary data from Type 2 Diabetes Mellitus sufferers without Chronic Kidney Failure from medical records at Hospital X in Jakarta in January-December 2023. The research data consisted of 368 respondents. The result was p-value = 0.688. The conclusion of this study is that there is no difference in mean between serum creatinine levels in controlled and uncontrolled Type 2 Diabetes Mellitus sufferers. Furthermore, research can be carried out using respondents with a duration of Diabetes Mellitus ≥ 10 year.

Efficacy of a portable non-mydriatic fundus camera for "rule-out papilledema" consultations: A prospective study.

Ophthalmology is frequently consulted to "rule-out papilledema." We assessed the efficacy of a portable, non-mydriatic fundus camera in detecting optic disc edema in the inpatient and emergency room settings during "rule-out papilledema" consultations, comparing to the gold standard dilated fundus examination (DFE). This prospective, blinded, cohort study included 124 non-mydriatic fundus photographs (62 patients) that were obtained over the 11-month enrollment period. The images, along with a brief clinical history, were evaluated independently by an attending neuro-ophthalmologist (NO), general ophthalmologist (GO), emergency room (ER) physician, and ophthalmology resident (OR), for the presence of disc edema and indication for consultation. Results were compared to DFE. Sensitivity, specificity, and area under receiver operating characteristic (ROC) curves were determined to evaluate the efficacy of the camera. On DFE, disc edema was present in 51 eyes (41.1%). Compared to DFE, NO assessment had the greatest combined sensitivity (84.3%) and specificity (97.3%) for the detection of disc edema, followed by that of GO (sensitivity 77.4%, specificity 100%), OR (sensitivity 96.1%, specificity 80.8%), and ER clinician (sensitivity 68.6%, specificity 89.0%). Areas under ROC curves for NO, GO, OR, and ER physician were all statistically significant for the detection of disc edema (0.908, P < 0.001; 0.892, P < 0.001; 0.885, P < 0.001; 0.788, P < 0.001, respectively). Clinicians were able to correctly identify optic disc edema using non-mydriatic fundus photography. Non-mydriatic fundus photography may be an effective inpatient or telemedicine tool to assess for optic disc edema.

Evaluation of a Novel Virtual Reality Simulated Alternate Cover Test to Assess Strabismus: A Prospective, Masked Study

A sensorimotor examination is the gold standard for strabismus diagnosis and quantification but requires a highly skilled examiner and may be limited by a child's cooperation. Virtual reality (VR) employs eye-tracking technology to monitor eye position and may be able to measure strabismus. The aim of this study was to assess a prototype VR-simulated alternate cover test to detect and measure strabismus. Prospective, masked diagnostic test study. Patients aged 5-18 years with visual acuity of 20/80 or better were prospectively enrolled to undergo strabismus measurements using a VR simulated alternate cover test (Olleyes, Inc., Summit, NJ) followed by an alternate cover test performed by a masked pediatric ophthalmologist or orthoptist. The main outcome measure was correlation between gold standard and VR-obtained strabismus measurements (in prism diopters [PD]) in primary gaze at near using Pearson correlation coefficients and Bland-Altman analysis with limits of agreement (LOA). A secondary measure was the diagnostic accuracy for the VR headset to detect strabismus. A total of 85 participants were enrolled, mean ± standard deviation age was 10.8 ± 3.8 years, 45.9% (39/85) male. 40.0% (34/85) had strabismus: 17.7% (15/85) esotropia, 22.4% (19/85) exotropia, and 5.9% (5/85) vertical strabismus. 52.9% (18/34) of strabismus was intermittent. The overall correlation between VR and gold standard strabismus measurements was moderate but significant (r = 0.42, 95% CI 0.22, 0.58, P < .001), and correlation was strong for esotropia and constant deviations (r = 0.74, 95% CI 0.38, 0.91, P = .001 and r = 0.74, 95% CI 0.39, 0.91, P < .001, respectively). In participants with horizontal strabismus, Bland-Altman analysis showed a mean difference between standard and VR measurements of 3.55 ± 8.33 PD for esotropia (upper and lower LOA 19.89, -12.78 PD) and 17.15 ± 11.20 PD for exotropia (LOA 39.09 and -4.79 PD). Sensitivity for detecting strabismus was low: 27.6% (95% CI 12.7, 47.2), but specificity was high: 87.5% (95% CI 75.9, 94.8). A prototype VR simulated alternate cover test showed a moderate but significant correlation with the gold standard sensorimotor examination and correlation was strong in those with esotropia and constant deviations. While the level of agreement demonstrated by this novel VR technology is promising, further improvements are needed before clinical deployment. However, this study demonstrates that VR has the potential to expand our ability to detect, measure, and monitor strabismus.

Prediction Models for HIV Infection in Infants: Analysis of Scoring Systems on Maternal, Infants, and Mode of Delivery Risk Factors.

Diagnosis for HIV in infants is hard to determine, particularly in limited-resource areas. A delay in the diagnosis of HIV-infected infants will lead to high morbidity and mortality. The purpose of this project is to construct a model of an HIV-positive infant and develop a useful and practical scoring system to estimate the likelihood of mother-to-child transmission that can be applied in the field. A cross-sectional study on 100 subjects through medical records of infants born to HIV-infected mothers was conducted at four hospitals and one community health center. Several models of risk prediction scores of HIV-infected infants were then made. Furthermore, the performed validation was performed on 20 subjects of infants born to mothers with HIV in three hospitals by comparing the scoring system and the result of the PCR RNA examination performed at the age of 6 weeks old. The risk of HIV-infected infants was higher in mothers who did not receive ARV through PMTCT programs (OR 33.6; 95% CI 4.0 to 282.2), pulmonary TB infection (OR 5.1; IK95% 1.6 to 16.0) and vaginal delivery (OR 9.2; IK95 2.2 to 38.0%). Two models can predict the occurrence of infected HIV infants effectively. Model 1 consists of maternal age, maternal ARVs, lung TB infection, gestational age, mode of delivery, and sex of the infants with sensitivity and specificity of 78.9% and 70.8% (AUC=0.817 [95% CI 0.709 to 0.926]) and likelihood ratio score of 4. Model 2 consists of ARVs to the mother, pulmonary TB infection, and mode of delivery with sensitivity and specificity of 73.7% and 86.1%; AUC value of 0.812 (95% CI 0.687 to 0.938) and likelihood ratio of 5. External Validation gave similar results to the Model 2 scoring system with PCR RNA. The prediction score of HIV-infected infants in Model 2 can be used in newborns of HIV-positive mothers as an effective and practical risk screening tool for HIV-infected infants before the gold standard examination by PCR.

Predictive Positive Value Xpert MTB/RIF in Detecting Mycobacterium tuberculosis on Adult Pulmonary Tuberculosis Patients in Dr. Soetomo Referral Hospital Surabaya Indonesia

Pulmonary tuberculosis is an infectious disease caused by Mycobacterium tuberculosis (Mtb) and transmitted via droplets. Southeast Asia is the largest contributor of TB, and Indonesia itself has the second-highest number in the world with an incidence of approximately 824000 cases. The most common symptoms of active TB are cough, fever, weight loss, and night sweats. The diagnosis can be established upon the confirmation that one of the specimens contains M. tuberculosis. Xpert MTB/RIF provides results in less than 2 hours, whereas culture takes approximately 2-6 weeks. This research aims to evaluate the characteristics and determine the Predictive Positive Value (PPV) percentage of GeneXpert MTB/RIF, utilizing parameters derived from the gold standard examination results, namely culture. This research method is descriptive- analytic based on secondary data extracted from medical records of patients receiving care at the multi-drug resistant TB (MDR-TB) Outpatient Management at Dr. Soetomo Referral Hospital Surabaya from the period January 2019 – April 2022. The results showed that the PPV level of GeneXpert MTB/RIF in detecting the presence of M. tuberculosis is 90%. The diagnosis of pulmonary TB is also supported by the chest X-ray infiltrate's appearance and clinical symptoms of cough, weight loss, fever, and night sweats. Smoking and diabetes are the most common comorbid and risk factors in TB. The conclusion of this study is that the PPV for diagnosing adult pulmonary TB using the Xpert MTB/RIF is relatively high. This suggests the potential use of this method as a diagnosing tool for accurately diagnosing pulmonary tuberculosis.

Assessment of urine metabolite biomarkers for the detection of S. haematobium infection in pre-school aged children in a rural community in Zimbabwe

BackgroundEarly diagnosis of urogenital schistosomiasis is key to its control and elimination. The current gold standard microscopic examination techniques lack sensitivity in detecting light Schistosomiasis infections in pre-school aged children thus it is urgent to develop diagnostic tools that may be integrated into control programs. In this study, we evaluated the diagnostic performance of urine metabolite biomarkers using a chemical reagent strip in the detection of S. haematobium infection in pre-school aged children. MethodsA case-control study was conducted involving 82 pre-school aged children that were age and sex matched. Urine samples were collected for 3 consecutive days and were evaluated using urine filtration gold techniques as the gold standard method. The samples were simultaneously measured for metabolite biomarkers specifically haematuria, proteins, ketones, nitrites, glucose, bilirubin and urobilinogen using chemical reagent strips. Pearson correlation test was used to measure the relationship between S. haematobium infection and the urine metabolite biomarkers. ResultsThe diagnostic performance of urine biomarkers were correlated with the microscopic examination urine filtration technique. Haematuria (r = 0.592, p = 0.0001) and proteinuria (r = 0.448, p = 0.0001) were correlated to S. haematobium infection. Negative correlations with p > 0.05 were recorded for ketones and urobilinogen. Highest sensitivity was 65.9 % (CI, 49.4 - 79.9) for haematuria whilst protein (albumin) biomarker had a lower specificity value of 43.9 % (28.5 – 60.3). Inversely, highest sensitivity was 87.8 % (73.8 – 95.9) for proteinuria whilst haematuria had a lower sensitivity value of 82.9 % (67.9 – 92.8). The positive predictive values ranged from 57.7 % (41.6 – 72.2) to 79.4 % (65.5 - 88.7) whereas negative predictive values ranged from 70.8 % (60.8 – 79.2) to 52.0 % (48.7 – 55.3). With respect to diagnostic efficiency, haematuria had a fair diagnostic performance with an area under the curve of 0.76 followed by proteinuria with proteinuria whilst the remaining metabolites fail discriminating ability with an area under the curve of <0.5. ConclusionAlthough haematuria and protein biomarkers in urine are moderately sensitive and specific, they are important morbidity indicators of urogenital schistosomiasis in pre-school aged that may be utilised during screening in schistosomiasis control programs. We recommend comprehensive analysis of biomarkers using metabolomics techniques to identify novel urine biomarkers.

Effective low-cost pediatric vision screening by naive nonophthalmic examiners using the 'Arclight' device.

To explore whether a low-cost ophthalmoscope (Arclight) can be used by naive nonophthalmic examiners to effectively screen for pediatric eye disease. Fifty-four children (108 eyes) were examined by five medical students using an Arclight. Gold standard examination was performed by an ophthalmologist using a slit lamp and indirect ophthalmoscope. Examinations performed included ophthalmoscopy of the optic disc, estimation of the cup-to-disc ratio (CDR), corneal light reflex test (CRT), Bruckner's reflex test (BRT), and evaluation of refractive error. We determined the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the nonophthalmologist's Arclight exam compared to the gold standard findings of comprehensive evaluation by pediatric ophthalmologists. Using the Arclight, the optic nerve exam was successfully completed in 65% of patients. CDRs above and below 0.5 could be determined with 66.7% sensitivity and 84.4% specificity. Arclight CRT measurements were significant (P < .00001) predictors of strabismus, with 80% sensitivity, 95.1%, specificity, 80% PPV, and 95.1% NPV. BRT was not a significant predictor of amblyopia, with a 34.6% sensitivity, 85.7% specificity, 69.2% PPV, and 58.5% NPV. Refractive error was estimated with a success rate of 81% for emmetropia, 38% for myopia, and 21% for hyperopia. The Arclight ease-of-use was rated on average as 4.4 (SD = 0.9) on a scale of 1 to 5, with 1 being the hardest and 5 being the easiest. Our study shows the Arclight as an affordable and effective alternative to the traditional ophthalmoscope for assessing eye disease in children. This device can improve eye health services in under-resourced regions.

A Clinicopathological Study of Parotid Gland Tumours

Abstract Background: The parotid gland is the largest salivary gland. Pleomorphic adenoma (PA) is the most common tumour found in the parotid gland. Most of the parotid tumours are painless and slow-growing. Ultrasound, computed tomography and magnetic resonance imaging are modalities of diagnosis. Fine-needle aspiration cytology (FNAC) is done in some cases, and its use is controversial. Aim: This clinicopathological study mainly aims at the demographic profile of the patient and clinical implications. Investigations were done and also evaluating the efficacy of FNAC in diagnosing parotid gland tumours. Materials and Methods: We conducted a prospective, hospital-based, observational study at our institution from December 2020 to June 2022. Forty patients who satisfied the inclusion and exclusion criteria were enrolled in the study. The study was analysed using SPSS version 25 developed by IBM. The categorical variables were presented as frequency and continuous data as mean, standard deviation (SD) and range with confidence interval. Categorical variables were compared using the Chi-square test; P &lt;0.05 is considered significant. The sensitivity, specificity positive predictive value (PPV) and diagnostic accuracy of FNAC against the gold-standard histopathological examination (HPE) were worked out. The results are shown in tabular and graphical format. Results: The incidence of swelling was higher in males than females. Swelling was the most common clinical feature of the parotid gland. The duration of the disease ranges from ½to 48 months with an SD of 8.26 and a 95% confidence interval. One patient presented with facial nerve involvement and one patient presented with lymph node involvement. Five patients gave a history of surgery done in the past, which indicates recurrence, 10 (25%) patients were smokers and 1 (3%) patient had a history of previous radiation. Amongst the population of smokers, Warthin’s tumours were the most common (50%), PA (20%), oncocytic lipoadenoma, mucoepidermoid (MEP) carcinoma and myoepithelial (MyoEP) tumours having 10% incidence. The radiological findings were evaluated showing PA in 72.5% of cases, Warthin’s in 7.5%, neoplasm in 7.5% and non-specific cyst parotitis in 2.5% each. One patient image shows features of malignancy. FNAC says that 67.5% were PA, 20% were Warthin’s cyst and non-specific cyst, MEP and inflammation, but in one patient, FNAC was inconclusive. Most of the study population underwent superficial parotidectomy (32.5%); 30% of the study group underwent superficial conservative parotidectomy, but 27.5% of patients underwent total conservative parotidectomy. About 2.5% of the study group underwent extracapsular excision and enucleation. However, 2 (5%) patients were done with simple excision only. After surgery, out of 40, 38 patients had neuropraxia which recovered on follow-up. The most common tumour was PA (67.5%), and Warthin’s (22.5%) malignant tumours like MEP and MyoEP were 5% and 2.5%, respectively. Rare benign tumours like oncocytic lipoadenoma were the finding of HPE in FNAC that was inconclusive in this case. The incidence of malignant tumours was more common in males than in females, and it was more common in the age group of 21–40 years. MEP carcinoma was the most common malignant tumour. The efficacy of FNAC was identified in terms of sensitivity, specificity, negative predictive value (NPV), PPV and diagnostic accuracy. The sensitivity for benign tumours was 91.89% and that for malignant tumours was 33.33%. The specificity was 33.33% for benign tumours and 100% for malignant tumours respectively. The PPV was 94.44% for benign and 100% for malignant tumours. NPV was 25% and 94.87%, respectively. The diagnostic accuracy was 87.5% and 95%. Conclusion: Although FNAC has some pitfalls, the high sensitivity, specificity and accuracy in diagnosing malignant lesions as evident from this study indicate that FNAC is a reliable diagnostic method when correctly performed and interpreted by an experienced cytopathologist. Not all parotid lesions are lumps are malignant. Most of the masses are benign in nature. FNAC is a simple, safe, painless and cost-effective method for easy diagnosis.

Distribution of Non-thyroid Neck Swellings according to Tissue of Origin and Their Radio-pathological Correlation

Abstract Introduction: Neck swellings are commonly found and can be presented as simple benign to malignant. Due to extensive differential diagnosis and similar presentation, the evaluation of neck swellings is more challenging. Most of the cases can be diagnosed after a detailed history and clinical examination of the head and neck, but the final diagnosis will be achieved by histopathological examination. Materials and Methods: The study was conducted from February 2020 to February 2023 on the basis of retrospective and prospective sampling. This study included all the patients with neck swellings, excluding thyroid, who had undergone excisional or incisional biopsy. The present study was carried out on 74 patients with non-thyroid neck swellings, which were classified five into main headings, i.e. lymph node swelling, salivary gland swellings, adipose tissue, neural tissue and skin and soft-tissue swellings as miscellaneous. Data were collected from patient records for retrospective sampling and radiological investigation, and ultrasonography (USG) and excisional or incisional biopsy were done for prospective sampling. A radiological and pathological correlation was analysed as benign and malignant. Results: Out of the 74 patients, n = 60, 81% were benign and n = 14, 19% were malignant. The most common swelling according to the tissue of origin was lymph node (n = 31, 41.9%) followed by salivary gland n = 15 (20.3%), adipose tissue (n = 7, 9.5%) and neural tissue (n = 6, 8.1%) origin. Other soft-tissue swellings were 20.3%. The overall sensitivity, specificity, positive predictive value, negative predictive value and radiological (USG) diagnosis accuracy to differentiate between benign and malignant are very similar to gold standard histopathological examination. Conclusion: Lymph node swellings were the most common swelling involving the neck region. USG diagnosis is highly sensitive for diagnosing malignant swellings but less good at confirming benign swellings. Radiological diagnosis is not a substitute for conventional surgical histopathology but is regarded as a precious complement in diagnosis. Newer diagnostic techniques are required to be infallible and accurate for further management.

Precision and accuracy of transcutaneous CO2 monitoring in infants born at 32-36 weeks of pregnancy on respiratory support

Background Respiratory disorders in premature neonates often require respiratory support. Continous transcutaneous monitoring is an available non-invasive option to monitor CO2 pressure, substituting the need for blood gas analysis as the gold standard evaluation in practice. Most studies have been conducted on very and extremely preterm neonates, but rarely in late and moderately preterm neonates. Objective To determine the precision and accuracy of transcutaneous CO2 pressure measuring devices compared to arterial blood gas analysis in neonates of 32-36 weeks gestational age who received respiratory support. Methods This diagnostic, cross-sectional study was conducted on 35 late and moderately preterm neonates of 32–36 weeks gestation who received cardiopulmonary resuscitation (CPR) in the Neonatology Unit at Rumah Sakit Cipto Mangunkusumo, Jakarta. Subjects were monitored with a transcutaneous CO2 monitor and blood gas analysis (BGA). CO2 pressure measurements were made three times from the two devices. Data were analyzed using Spearman’s correlation and Bland-Altman tests to determine the precision and accuracy of transcutaneous monitoring by comparing its mean difference (MD) to BGA as the gold standard measurement. Results Spearman’s analysis revealed a significant positive correlation between BGA and transcutaneous CO2 monitoring (P&lt;0.001). However, the Bland - Altman test revealed a level of agreement between measuring devices was -14.46 to 6.9, with mean difference of -3.78; indicating poor precision of the transcutaneous evaluation regardless its high accuracy compared to its gold standard. Conclusion The transcutaneous CO2 monitoring device has low precision, but a strong positive correlation to BGA; underlining its high accuracy in practice. Transcutaneous CO2 monitoring cannot replace BGA, the gold standard examination.

Comparison of Elva Diagnostic SARS-CoV-2 Saliva Nucleic Acid Test Kit with RT-qPCR and Rapid Antigen Tests in COVID-19 Patients

The practical application of the reverse transcription loop-mediated isothermal amplification (RT-LAMP) technique has been confirmed in diagnosing different viral infections. Nevertheless, its accuracy in identifying SARS-CoV-2, particularly in practical clinical situations, has not been thoroughly investigated. This study aims to investigate the sensitivity and specificity of the Elva Diagnostic SARS-CoV-2 Saliva Nucleic Acid Test Kit, utilizing the RT-LAMP and Rapid Antigen Test (RAT) methods for in vitro diagnostic testing, compared to the real-time quantitative polymerase chain reaction (RT-qPCR) method throughout the progression of COVID-19. Method: This study employed an analytical observational diagnostic test at Dr. Soetomo Regional Public Hospital, Surabaya, from March 2022 to May 2022. This research involved 54 samples of saliva and nasopharyngeal swabs obtained from 36 patients confirmed positive for COVID-19 and 18 samples from subjects not confirmed to have COVID-19, tested using the RT-qPCR method. The diagnostic performance of both the RT-LAMP and RAT methods was assessed by calculating their sensitivity and specificity in comparison to RT-qPCR, beginning from the time the patient was confirmed positive for COVID-19. The suitability of each method was analyzed using Cohen’s kappa. The nucleocapsid (N) protein gene from SARS-CoV-2 RNA was detected with RT-LAMP and RAT test kits which showed incompatibilities with the RT-qPCR method (p value 0.308). The positive and negative results with the RT-LAMP and RAT method examinations were similar in number compared to the RT-qPCR method, where the positive results in the RT-LAMP and RAT methods were 2 subjects and the negative results were 52 subjects. Based on the results, only 2 confirmed cases had positive results with RT-LAMP and RAT, which means the sensitivity of both tests is only 5.5% and both are poor screening tests for patients suspected of having COVID-19. In addition, the specificity of RT-qPCR as the gold standard examination method for diagnosing COVID-19 cannot be replaced by the RT-LAMP and RAT methods.

Cryptococcal meningitis presenting as simple headache in early adulthood HIV-infected patient: A case report

Cryptococcal meningitis is a rare disease caused by Cryptococcus neoformans or Cryptococcus gatii as the fungal pathogen in humans. The disease is highly prevalence in people living with human immunodeficiency virus (HIV) and is the major cause of mortality in an immunocompromised individual. This life-threatening disease does not often occur with specific signs and symptoms. We reported a case of an early adulthood HIV-infected patient with a mild headache and low-grade fever. There were no altered mental status or other significant specific manifestations. Blood examination, chest radiograph, and computed tomography scan revealed no significant results. C. neoformans were isolated from a culture of the cerebrospinal fluid specimen as the conventional gold standard examination for cryptococcal meningitis. A positive result was confirmed in the India ink staining preparation. The patient was treated with fluconazole monotherapy for the induction and consolidation phase and showed a positive disease progression during observations.

Confirmatory Assay for Laboratory Diagnosis of Malaria Using Molecular Approach.

Prompt malarial treatment and surveillance is crucial for accurate diagnosis of Plasmodium Sp. Gold standard microscopic examination has been widely applied for diagnosis of malaria in most part of the endemic areas. But in case of submicroscopic and asymptomatic microscopic diagnosis is questioned. The study aims to develop a simple, cost effective & robust nucleic acid amplification technique for the detection of malaria parasite. Study population included 50 clinically diagnosed positive malaria patient samples from various pathological laboratories. Microscopy by preparing thick film was carried out of every sample for primary screening in the available facility of Surat Raktadan Kendra & Research Centre- Blood Bank. The conventional PCR (Polymerase Chain Reaction) was applied for genus-specific amplification targeting the 18S rRNA gene of Plasmodium. Agarose gel electrophoresis was used to separate and analyze the amplified PCR product using 2% Agarose gel. The study shows that nested PCR not only detected all microscopic positive samples, but also detected submicroscopic infections that were missed or misread by microscopy. Hence, the sensitivity of molecular based detection technique is proved to be more compared to microscopic examination.

Accuracy of Extraoral Bitewing Compared with Histopathology in Proximal Caries Detection of Primary Molar Teeth

An accurate diagnosis of dental caries leads to a suitable treatment plan and prevents premature loss of primary teeth. Intraoral bitewing radiography helps caries determination but has limitations in pediatric patients with severe gag reflexes while the extraoral bitewing radiograph resolved the patients who refused to undergo intraoral radiographs. The research objective was to compare the accuracy of extraoral bitewing radiography and the gold standard histopathological examination for proximal caries detection in the primary molars. Twenty-four extracted primary molars with and without proximal caries were divided into three groups and arranged in the mimetic alveolar sockets of a 3D-printed skull and mandible. Two observers evaluated extraoral bitewing images separately twice at one-week intervals. The weighted kappa coefficients showed excellent intra-observer and inter-observer agreements between each session of the extraoral bitewing radiographic assessments. The Mann-Whitney U test showed no difference between the radiographic grading scores of extraoral bitewing images and the gold standard. The sensitivity, positive predictive value (PPV), negative predictive value (NPV), and the area under the receiver operating characteristic (ROC) curve in cavitated carious lesions were higher than in non-cavitated carious lesions. In conclusion, extraoral bitewing is an alternative radiography for pediatric patients who are either uncooperative or intolerant to intraoral radiography.

Diagnostic accuracy of tele-dentistry in screening children for dental caries by community health workers in a lower-middle-income country.

Tele-dentistry can be useful for dental caries screening of children, especially in lower-middle-income countries (LMICs). To evaluate the diagnostic accuracy of mobile phone photographs taken by a community health worker (CHW) for caries detection in Iran. Children aged 6-12 years were visually examined by a paediatric dentist. Following dental examinations, intraoral photographs were taken by a trained CHW. Two remote dentists assessed intraoral photographs for dental caries. Diagnostic accuracy of tele-dentistry for caries detection was evaluated. In addition, the questionnaire about oral health and parents' views towards tele-dentistry was prepared. One hundred thirty-one children aged 8.74 ± 1.62 years participated. The caries prevalence was 30% for the whole dentition. Tele-dentistry demonstrated high accuracy, with a sensitivity exceeding 80% and specificity exceeding 90%. The inter-rater reliability for remote dentists' assessments to the gold standard dental examination ranged from substantial to almost perfect (kappa: 75%-93%). Additionally, 80% of parents whose children participated in this study had positive views towards tele-dentistry. Tele-dentistry was shown to be an alternative approach to clinical examinations for caries detection among school children. Employing non-dental care professionals in tele-dentistry has been emerged as a reliable and cost-effective approach, especially in LMICs.

Evaluation of a telemedicine-enabled universal eye health delivery model in rural southern India.

To evaluate the accuracy of tele-ophthalmic examination (TOE) for common ocular conditions in comparison with the gold-standard in-person examination (IPE) for diagnosis and treatment advice. In a prospective, diagnostic accuracy validation study, we recruited 339 consecutive new patients, aged ≥16 years, visiting a vision centre (VC) associated with Aravind Eye Hospital in south India during January and February, 2020. All participants underwent the TOE, followed by IPE on the same visit. The in-person ophthalmologist was masked to the TOE diagnosis and treatment advice. Data were analysed via the sensitivity specificity of TOE versus the gold-standard IPE. TOE achieved high sensitivity and specificity for identifying normal eyes with 87.4% and 93.5%, respectively. TOE had high sensitivity for cataracts (91.7%), infective conjunctivitis (72.2%), and moderate sensitivity for pterygium (62.5%), DR (57.1%), non-serious injury (41.7%), but low sensitivity for glaucoma (12.5%). TOE had high specificity ranging from 93.5% to 99.8% for all diagnoses. The sensitivity for treatment advice ranged from 58.1% to 77.2% and specificity from 96.9% to 100%. The TOE in VCs has acceptable accuracy to an IPE by an ophthalmologist for correctly identifying and treating major eye ailments. Through providing universal eye care to rural populations, this model may contribute to work toward achieving Universal Health Coverage, which is a linchpin of the health-related U.N. Sustainable Development Goals (SDG).

Quantification of aortic valve fibrosis and calcification by computed tomography angiography: a prospective head-to-head comparison with histology

Abstract Background Calcific aortic stenosis (AS) is characterized by leaflet degeneration involving fibrocalcific alterations which limit leaflet mobility and eventually lead to obstruction of flow across the aortic valve. While cardiac computed tomography (CT) has been routinely used for quantification of aortic valve calcium in individuals in whom echocardiography is inconclusive, recent studies on quantification of aortic valve fibrosis are lacking histological validation. [1,2] Purpose We, thus, aimed to validate a non-invasive CTA-derived quantitative characterization of aortic valve tissue against histologic examination of excised aortic valve leaflets. Methods In this prospective study, patients underwent CTA within a month before surgical aortic valve replacement for aortic stenosis. Tomographic valve tissue components were identified by Gaussian mixture modeling applied to CTA, by automatically fitting Gaussian functions to the Hounsfield Unit (HU) histograms for blood pool, non-calcific, and calcific aortic valve tissue. Tissue composition, expressed as % [(tissue component volume / total tissue volume) × 100%], was automatically calculated. For histologic evaluation, explanted valve leaflets were stained with Movat's Pentachrome. For every leaflet, three non-consecutive 5-µm sections were obtained. Further, an automatic algorithm detecting pixel intensities was applied for color differentiation and quantification of tissue components (Figure 1). Separate measurements from all the sections of the single valve were finally averaged and compared with CTA-derived calculations. Results A total of nineteen patients (63% men, 67±8 years old) undergoing isolated surgical aortic valve replacement for severe aortic stenosis with preoperative CTA were evaluated. The mean proportion of non-calcific aortic valve tissue was 68±16% in CTA and 75±3% on Movat’s Pentachrome staining (p=0.004, paired samples comparison). There was a strong correlation between the two modalities (r=0.856, p&amp;lt;0.001; Figure 2A). Intermodal repeatability between CTA and histology for non-calcific tissue quantification was excellent with an interclass correlation coefficient of 0.855 (95% CI 0.663 – 0.942, p&amp;lt;0.001), coefficient of repeatability of 16.8% and bias of -6.7% (p=0.234, Figure 2B). Conclusions CTA-derived characterization of aortic valve tissue provides an accurate quantification of non-calcific tissue as compared with gold-standard histologic examinations of explanted stenotic valves.Figure 1Figure 2

Ultrasonographic screening for developmental dysplasia of the hip: the Graf method revisited.

Until the 1980s, the diagnosis of developmental dysplasia of the hip (DDH) was based on clinical examination and radiographic imaging. In 1980, Reinhard Graf developed his own ultrasonographic method for the examination of the infant hip joint. Graf's method evaluates the osseous and cartilaginous coverage of the femoral head by the acetabulum in the infantile hip joint by measuring the angles α and β. The validity of Graf method is that with these measurements the hip joint is further classified by Graf classification into types I to IV that guide treatment. Currently, Graf method is considered the gold standard examination for the diagnosis of DDH in many European countries. This review article aims to discuss the incidence, risk factors and pathophysiology of DDH, and to emphasize on the Graf method for the evaluation, classification, prevention and further management of this entity.