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PubMed2005

Socioeconomic status and the utilization of diagnostic imaging in an urban setting.

BACKGROUND: In publicly funded health care systems, the utilization of health care services should be equitable, irrespective of socioeconomic status (SES). Although the association between SES and health care utilization has been examined in Canada relative to surgical, cardiac and preventive health care services, no published studies have specifically explored the association between SES and diagnostic imaging. METHODS: We examined over 300,000 diagnostic imaging claims made in the Winnipeg Regional Health Authority between Apr. 1, 2001, and Mar. 31, 2002. Using patient postal codes, we assigned SES on the basis of average household incomes in Canada's 1996 census. Using multiple regression, we examined the association between income quintile, patient age group (< or =16, 17-64, > or = 65 years), patient morbidity level according to the Johns Hopkins University Adjusted Clinical Group method (high, moderate, low), and imaging modality (general radiology, vascular, computed tomography, magnetic resonance, and general and obstetric ultrasound). RESULTS: Relative rates (RR) of diagnostic imaging utilization (highest v. lowest income quintile) were significantly increased in pediatric and adult patient groups at all morbidity levels receiving general radiology (highest RR 2.47, 95% confidence interval [CI] 2.07-2.93); pediatric and adult patient groups at high and low morbidity levels and elderly patient groups at low morbidity levels receiving general ultrasound (highest RR 2.26, 95% CI 1.20-4.26); pediatric and adult patient groups at all morbidity levels and elderly patients at high and moderate morbidity levels receiving magnetic resonance imaging (highest RR 2.51, 95% CI 1.78- 3.52); and adult patient groups at all morbidity levels receiving computed tomography (highest RR 1.46, 95% CI 1.35- 1.59). A lower RR of diagnostic imaging utilization in the highest income quintile was found only among patients receiving obstetric ultrasound (RR 0.80, 95% CI 0.73-0.87). No significant associations were found among elderly patients receiving general radiology or computed tomography or adult patients receiving vascular imaging. INTERPRETATION: We found a pattern of increased diagnostic imaging utilization in patient groups with a higher SES. Further research is needed to better understand the nature of this finding and how it contributes to health outcomes.

Adolescent↗
PubMed2003

A five-year prospective study of diagnostic orphans for alcohol use disorders.

OBJECTIVE: One consequence of the DSM-IV diagnostic system for substance abuse and dependence is that there are individuals who might endorse one or two of the criterion items for dependence but not meet criteria for abuse. These persons have been referred to as "diagnostic orphans." The aim of the analyses presented here is to further understanding about this potentially important group. METHOD: The DSM-IV categorical approach was used to determine alcohol-related diagnoses for 439 young adult men. Structured face-to-face follow-up interviews were administered 5 years later. RESULTS: At the beginning of the evaluation period, 14.6% (n = 64) of the men were alcohol dependent, 18.2% (n = 80) fulfilled criteria for alcohol abuse, 16.4% (n = 72) did not meet criteria for an alcohol use disorder but endorsed one or two of the dependence criteria and 50.8% (n = 223) reported none of the dependence items. At the initial interview, and again 5 years later, the diagnostic orphans reported alcohol and drug use histories that fell between the histories of those with dependence and those with no alcohol-related difficulties. The orphans were most similar to the men with abuse, although they had lower quantities and frequencies of alcohol use, endorsed fewer additional alcohol-related problems and reported less involvement with drugs compared with that group. CONCLUSIONS: Although the diagnostic orphans were more similar to the subjects with alcohol abuse than they were to those with dependence or no diagnosis, the data do not necessarily support combining the orphans with those with abuse. These diagnostic orphans do, however, constitute an important group that carries an enhanced risk for alcohol use disorders and should be closely followed.

Adult↗
PubMed2005

[Evidence-based practice applied to diagnostic reasoning].

Nurses apply knowledge, perceptual and cognitive skills to analyze patient data and propose nursing interventions. The interventions' outcomes depend on their appropriateness which, in turn, depends on the accuracy of nurses' interpretations. The purpose of this paper is to discuss the use of evidenced-based practice (EBP) for nursing diagnostic reasoning, by means of a written case study. The principles of EBP in diagnostic reasoning are: validity of a diagnostic test; ability of a test to discriminate those who do or do not display a specific response; ability of a test to estimate the magnitude of a response; and the appropriateness of a diagnostic test within the clinical context. Gaps in nursing knowledge jeopardize the application of EBP principles in clinical nursing assessment and diagnosis. The authors present a framework to demonstrate the application of EBP to diagnostic reasoning.

Decision Making↗
PubMed2001

Biotechnology in the development of new vaccines and diagnostic reagents against tuberculosis.

Tuberculosis (TB) is a disease of global concern. About one third of the world population is infected with Mycobacterium tuberculosis. Every year, approximately 8 million people get the disease and 2 million die of TB. The currently available vaccine against TB is the attenuated strain of Mycobacterium bovis, Bacillus Calmette Guerin (BCG), which has failed to provide consistent protection in different parts of the world. The commonly used diagnostic reagent for TB is the purified protein derivative (PPD) of M. tuberculosis, which is nonspecific because of the presence of antigens crossreactive with BCG and environmental mycobacteria. Thus there is a need to identify M. tuberculosis antigens as candidates for new protective vaccines and specific diagnostic reagents against TB. By using the techniques of recombinant DNA, synthetic peptides, antigen-specific antibodies and T cells etc., several major antigens of M. tuberculosis have been identified, e.g. heat shock protein (hsp)60, hsp70, Ag85, ESAT-6 and CFP10 etc. These antigens have shown promise as new candidate vaccines and/or diagnostic reagents against TB. In addition, recent comparisons of the genome sequence of M. tuberculosis with BCG and other mycobacteria have unraveled M. tuberculosis specific regions and genes. Expression and immunological evaluation of these regions and genes can potentially identify most of the antigens of M. tuberculosis important for developing new vaccines and specific diagnostic reagents against TB. Moreover, advances in identification of proper adjuvant and delivery systems can potentially overcome the problem of poor immunogenicity/short-lived immunity associated with protein and peptide based vaccines. In conclusion, the advances in biotechnology are contributing significantly in the process of developing new protective vaccines and diagnostic reagents against TB.

Animals↗
PubMed2026

Diagnostic Performance of Machine Learning for Systemic Lupus Erythematosus: Systematic Review and Meta-Analysis.

BACKGROUND: Early and accurate diagnosis of systemic lupus erythematosus (SLE) and its organ involvement is essential. Previous reviews of machine learning (ML) in SLE combined heterogeneous tasks and validation strategies and may have overinterpreted model performance. OBJECTIVE: This study evaluated the diagnostic performance of ML and deep learning (DL) models for 3 clinically distinct SLE-related tasks: SLE classification or diagnosis, lupus nephritis (LN) diagnosis, and neuropsychiatric systemic lupus erythematosus (NPSLE) discrimination. We also assessed methodological quality and certainty of evidence. METHODS: PubMed, Embase, Cochrane Library, Web of Science, and IEEE Xplore were searched from January 2014 to April 2026. Eligible peer-reviewed diagnostic accuracy studies developed or validated ML or DL models for 1 of the 3 prespecified tasks, used an accepted reference standard, and provided data for a 2&#xd7;2 contingency table. Bivariate random-effects meta-analyses with the Hartung-Knapp-Sidik-Jonkman adjustment were used to pool sensitivity and specificity. We reported 95% prediction intervals (PIs), assessed risk of bias using the Quality Assessment of Diagnostic Accuracy Studies for Artificial Intelligence tool (QUADAS-AI; Viknesh Sounderajah [Imperial College London]), and evaluated certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation framework for diagnostic test accuracy. RESULTS: Twenty-nine studies were included: 17 for SLE classification, 5 for LN diagnosis, and 7 for NPSLE discrimination. In the primary task-stratified analysis, pooled sensitivity was 0.91 (95% CI 0.86-0.94; 95% PI 0.56-0.99), and pooled specificity was 0.94 (95% CI 0.91-0.96; 95% PI 0.69-0.99), with low heterogeneity (I&#xb2;=23.9% and 22.9%, respectively). DL models showed a sensitivity of 0.93 and specificity of 0.95, compared with 0.88 and 0.94 for traditional ML models. Certainty of evidence was high for most analyses but low for LN diagnosis because of inconsistency and imprecision. All studies were retrospective, and only 9 of 29 (31%) performed independent external validation. Overall risk of bias was high or unclear in 22 of 29 (75.9%) studies. No study reported model calibration, decision-curve analysis, or net clinical benefit. CONCLUSIONS: ML models showed promising diagnostic accuracy across 3 distinct SLE-related tasks, but wide PIs, limited external validation, and pervasive risk of bias restrict conclusions about real-world generalizability. Prospective multicenter studies with standardized tasks and reference standards, independent external validation, and formal assessment of calibration and clinical utility are required before clinical implementation.

Humans↗
PubMed2006

A clearing house for diagnostic testing: the solution to ensure access to and use of patented genetic inventions?

In genetic diagnostics, the emergence of a so-called "patent thicket" is imminent. Such an overlapping set of patent rights may have restrictive effects on further research and development of diagnostic tests, and the provision of clinical diagnostic services. Currently, two models that may facilitate access to and use of patented genetic inventions are attracting much debate in various national and international fora: patent pools and clearing houses. In this article, we explore the concept of clearing houses. Several types of clearing houses are identified. First, we describe and discuss two types that would provide access to information on the patented inventions: the information clearing house and the technology exchange clearing house. Second, three types of clearing houses are analysed that not only offer access to information but also provide an instrument to facilitate the use of the patented inventions: the open access clearing house, the standardized licences clearing house and the royalty collection clearing house. A royalty collection clearing house for genetic diagnostic testing would be the most comprehensive as it would serve several functions: identifying patents and patent claims essential to diagnostic testing, matching licensees with licensors, developing and supplying standardized licences, collecting royalties, monitoring whether users respect licensing conditions, and providing dispute resolution services such as mediation and arbitration. In this way, it might function as an effective model for users to facilitate access to and use of the patented inventions. However, it remains to be seen whether patent holders with a strong patent portfolio will be convinced by the advantages of the royalty collection clearing house and be willing to participate.

Access to Information↗
PubMed2005

Inventions leading to the development of the diagnostic test kit industry--from the modern pregnancy test to the sandwich assays.

The universities are encouraged by the government nowadays to stimulate innovations and also to provide the proper machinery for assisting the protection and commercialisation of innovations. A better understanding of the innovation process may help to create an atmosphere suitable for inventions at the university. Examples can be taken from successful innovations previously made at the university. During the 1960's I made a series of inventions, which ultimately led to the development of the diagnostic test kit industry. The first, which I made as an undergraduate, was a simple and reliable test kit for diagnosis of pregnancy. This was followed by the solid phase radioimmunoassay and a solid phase assay for vitamin B12; next, the dual specific non-competitive sandwich assay and the in-vitro test for diagnosis of allergy, called RAST (Radioallergosorbent test). Organon in Holland with the pregnancy test kit, and Pharmacia in Sweden with test kits for radioimmunoassay, became pioneers among the diagnostic test kit industries. Pharmacia Diagnostics later became one of the leading diagnostic test kit companies in the world and has continued to be so in the field of allergy diagnosis. Each one of these inventions started with a few unique observations leading to a technical development. The pregnancy test as well as the allergy test emerged from the development of assay methods with unique qualities with the subsequent search for appropriate applications. The foreseeing of a commercial value on a future market was a very important step. This was followed by the search for a suitable industry interested to exploit the invention with its new business opportunity i.e. apply for a patent, produce and market the products, which in my case consisted of the necessary reagents and equipments for particular diagnostic tests. Finally, an agreement had to be settled between the entrepreneur and the inventors. This report describes these inventions and particularly discusses some crucial steps of the innovation processes.

Binding, Competitive↗
PubMed2026

Integrating metagenomic next-generation sequencing into a multimodal diagnostic framework for spinal infection: enhancing etiological identification and clinical prediction.

BACKGROUND: Spinal infection (SI) remains diagnostically challenging because of heterogeneous etiologies, nonspecific clinical manifestations, and the limited sensitivity of conventional microbiological approaches, particularly following empirical antimicrobial exposure. Although metagenomic next-generation sequencing (mNGS) enables unbiased pathogen detection, its incremental clinical value beyond pathogen identification and its role within integrated diagnostic strategies remain incompletely established. METHODS: We retrospectively analyzed 208 consecutive patients with suspected SI between August 2022 and August 2025. Final diagnoses were established using a multidisciplinary-adjudicated composite reference standard incorporating clinical, radiological, microbiological, and histopathological evidence. The diagnostic performance of mNGS was compared with conventional culture and histopathology. Furthermore, multimodal predictive models integrating clinical variables and microbiological information were developed using L1-regularized logistic regression. RESULTS: In the comparative cohort, mNGS achieved a significantly higher diagnostic yield than culture (66.5% vs. 27.41%, P < 0.001). Among confirmed SI cases, mNGS demonstrated higher sensitivity than conventional culture (91.67% vs. 40.15%, P < 0.001). mNGS identified a substantially broader pathogen spectrum, ranging from fastidious organisms such as Mycobacterium tuberculosis and Brucella to rare pathogens including Talaromyces marneffei and Coxiella burnetii, and maintained robust sensitivity (98.2%) despite prior antibiotic exposure. While an integrated clinical model achieved an AUC of 0.916, mNGS as a standalone modality provided superior discriminative power (AUC = 0.889) compared to histopathology (AUC = 0.836), the Conventional Biomarker Model (AUC = 0.742), and culture (AUC = 0.693). CONCLUSIONS: mNGS is a high-yield diagnostic tool for spinal infection, particularly in culture-negative and antibiotic-pretreated scenarios. Integrating mNGS into a multimodal clinical framework facilitates etiological clarity and precision antimicrobial therapy.

Humans↗
PubMed1997

Use of Iliad to improve diagnostic performance of nurse practitioner students.

Nurse practitioners (NPs) have dual goals as primary care providers, combining the traditional goals of nursing with extended goals as diagnosticians. Diagnostic reasoning, therefore, is a critical component of NP education. Iliad, a computerized diagnostic reasoning expert system, has been used effectively to teach diagnostic skills to medical students. A pilot study was undertaken to determine the effects of Iliad training on NP students' diagnostic skill performance and to identify technical and instructional issues of implementation. The study found that the use of Iliad improved NP students' diagnostic reasoning, and that the training effects were modified by prior nursing experience. Successful use of Iliad required planning, faculty commitment, and technical support.

Clinical Competence↗
PubMed2006

When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials?

The clinical value of using a new diagnostic test depends on whether it improves patient outcomes beyond the outcomes achieved using an old diagnostic test. When can studies of diagnostic test accuracy provide sufficient information to infer clinical value, and when do clinicians need to wait for results from randomized trials? The authors argue that accuracy studies suffice if a new diagnostic test is safer or more specific than, but of similar sensitivity to, an old test. However, if a new test is more sensitive than an old test, it leads to the detection of extra cases of disease. Results from treatment trials that enrolled only patients detected by the old test may not apply to these extra cases. Clinicians need to wait for results from randomized trials assessing treatment efficacy in cases detected by the new diagnostic test, unless they can be satisfied that the new test detects the same spectrum and subtype of disease as the old test or that treatment response is similar across the spectrum of disease.

Diagnostic Techniques and Procedures↗
PubMed1998

The basic clinical diagnostic framework synergized.

OBJECTIVE: To develop a diagnostic framework that would help defining clinical problems by the expanded understanding with traditional Chinese medicine (C Med) and western medicine (W Med). METHODS: The basic attributes of diagnosis and the use of diagnostic techniques of W Med and C Med are reviewed. Some of the various diagnostic labels and their meanings are also preliminarily reviewed. A consolidatory approach is made to synergize the usefulness of the two disciplines based on the principles of the two schools. RESULTS: A synergized basic diagnostic framework is developed. The disease (the disease diagnosis, [symbol: see text]), the state of the inner core (the core diagnosis, [symbol: see text]) should be defined. The term "systemic clues" is used to describe the symptom complex and conglomerate evidence describing the transient or sustained reaction of the inner core to environment. This is an analytical summary of its pathophysiological changes in reaction to the environmental insults. CONCLUSIONS: The application and use of the framework are discussed and propositions are made. The synergized diagnostic platform represents a starting effort to form a unified basis to exchange clinical diagnosis between W Med and C Med. Such framework may facilitate looking for new treatment modalities and results can be compared across different centres.

Diagnosis, Differential↗
PubMed1999

Use of diagnostic imaging services in the Central Region by general practitioners.

AIM: To record general practitioners use of diagnostic imaging facilities in areas with different levels of access. METHOD: A random sample of general practitioners from three different areas kept a prospective record for one month of all patients referred to diagnostic imaging facilities, the outcomes of these investigations and the total number of patients seen. RESULTS: Referrals for diagnostic imaging services were significantly different between the localities (p = 0.014). The area with the least restrictions on access and the highest referral rate showed the greatest variation between doctors. There was a significant difference (p = 0.047) between the localities for patients who could not be referred because of restricted access and the cost of the services. The majority (68%) of patients who were unable to access these services were referred to the hospital for admission, for an outpatient appointment or to the accident and emergency department. There was little difference between the localities in either the presence or absence of pathology, or in the proportion of patients where the diagnosis was changed as a result of the diagnostic imaging investigation. CONCLUSION: Improved access to diagnostic imaging services for patients of general practitioners would result in better patient management and prevent unnecessary hospital referrals.

Adult↗
PubMed2001

[Development of a diagnostic kit of enzyme-linked immunoassay for detecting serum anti-hepatitis E virus IgG].

OBJECTIVE: To develop a diagnostic kit for detecting serum anti-hepatitis E virus (HEV) IgG with enzyme-linked immunoassay (ELISA). METHODS: The diagnostic kit of detecting anti-HEV IgG with ELISA was prepared by two synthetic HEV peptides used for coating the solid-phase to capture the antibody against HEV in serum, and then by horseradish peroxidase antihuman IgG (gamma chain) added as the second antibody to bind the anti-HEV IgG in serum. Its sensitivity, specificity, precision and stability were measured and clinically evaluated. RESULTS: The sensitivity, specificity, and precision of the diagnostic kit detected by the China National Institute for the Control of Pharmaceutical and Biological Products were 90% (1/10), 100% (0/30) and < 15%, respectively, meeting the national standards for detecting serum anti-HEV IgG with ELISA. The ELISA Kit is stable for 1 year at least under 4 degrees C. The total consistency rates were 100% (43/43) and 96.6% (86/89), as compared with Genelabs and Singaporean DBL kits. This diagnostic kit for detecting serum anti-HEV IgG with ELISA was evaluated and approved by the State Drug Administration, China and a certificate was conferred in 1998. CONCLUSIONS: The diagnostic kit for detecting anti-HEV IgG with ELISA can be used for epidemiological studies and clinical diagnosis of HEV infection.

Antibodies, Viral↗
PubMed2002

[Basic principles of selection and use of diagnostic tests: practical applicability to individual patients].

In clinical practice, in order to design and implement a specific therapeutic plan, as well as communicating an appropriate prognosis, the doctor needs to establish a precise diagnosis of the condition. Sometimes all one needs is a clinical impression. More often, however, the definition of an accurate diagnosis will mandate the interpretation of specific diagnostic tests as well. The rational use of diagnostic tests in cardiology--whether laboratorial or imaging--should be based on three factors: 1) validity of the study's results about the test; 2) diagnostic properties of the test and 3) applicability of the test in clinical setting. The rational use and correct interpretation of diagnostic tests are based on these three factors. In two previous articles, we presented the basic principles concerning the validity of the results from the study that defined the specific test as well as the diagnostic properties of the tests. In this final article we discuss the applicability of the test to the individual patient in clinical practice.

Diagnostic Tests, Routine↗
PubMed2002

[CT-guided percutaneous transthoracic aspiration biopsy of chest lesions: factors influencing the diagnostic accuracy].

OBJECTIVE: To investigate the factors influencing the diagnostic accuracy of CT-guided percutaneous transthoracic aspiration biopsy of chest lesions. METHODS: Data of pathology and clinical follow-up of 224 patients who had undergone CT-guided percutaneous transthoracic biopsy were collected. Univariate analysis and multivariate stepwise Logistic regression analysis were made to study the influence of the patient-related factors (sex, age, and presence of emphysema), lesion-related factors (histology, size, location, depth, and presence of cavity discovered by CT), and procedure factor (posture of patient during operation) on the diagnostic accuracy of CT-guided biopsy. RESULTS: (1) One hundred and sixty-five lesions were diagnosed as malignant and 79 lesions as benign. The accuracy rate of CT-guided biopsy was 82.4% (201/244). Univariate analysis showed that the diagnostic accuracy rates of CT-guided biopsy for malignant and benign lesions were 88.5% and 69.6% respectively (chi(2) = 13.096, P < 0.01). The mean diameters of the lesions with correct diagnosis and of those misdiagnosed were 4.0 cm +/- 1.8 cm and 3.1 cm +/- 1.4 cm respectively (F = 8.805, P < 0.01). (2) Multivariate stepwise Logistic regression analysis showed that among the various factors only histology (regression coefficient = 0.320, Wald chi(2) = 7.126, P < 0.01) and size (regression coefficient = 1.114, Wald chi(2) = 4.951, P < 0.05) were significantly associated with diagnostic accuracy. CONCLUSION: Histology and size of lesion are the determining factors for diagnostic accuracy of CT-guided transcutaneous thoracic needle aspiration biopsy.

Adolescent↗
PubMed2003

Mutual information as an index of diagnostic test performance.

OBJECTIVES: This paper demonstrates that diagnostic test performance can be quantified as the average amount of information the test result (R) provides about the disease state (D). METHODS: A fundamental concept of information theory, mutual information, is directly applicable to this problem. This statistic quantifies the amount of information that one random variable contains about another random variable. Prior to performing a diagnostic test, R and D are random variables. Hence, their mutual information, I(D;R), is the amount of information that R provides about D. RESULTS: I(D;R) is a function of both 1). the pretest probabilities of the disease state and 2). the set of conditional probabilities relating each possible test result to each possible disease state. The area under the receiver operating characteristic curve (AUC) is a popular measure of diagnostic test performance which, in contrast to I(D;R), is independent of the pretest probabilities; it is a function of only the set of conditional probabilities. The AUC is not a measure of diagnostic information. CONCLUSIONS: Because I(D;R) is dependent upon pretest probabilities, knowledge of the setting in which a diagnostic test is employed is a necessary condition for quantifying the amount of information it provides. Advantages of I(D;R) over the AUC are that it can be calculated without invoking an arbitrary curve fitting routine, it is applicable to situations in which multiple diagnoses are under consideration, and it quantifies test performance in meaningful units (bits of information).

Area Under Curve↗
PubMed1992

Physicians' utilization and charges for outpatient diagnostic imaging in a Medicare population.

OBJECTIVES AND RATIONALE: For 10 common clinical presentations, we assessed differences in physicians' utilization of and charges for diagnostic imaging, depending on whether they performed imaging examinations in their offices (self-referral) or referred their patients to radiologists (radiologist-referral). METHODS: Using previously developed methodologies, we generated episodes of medical care from an insurance claims database. Within each episode, we determined whether diagnostic imaging had been performed, and if so, whether by a self-referring physician or a radiologist. For each of the 10 clinical presentations, we compared the mean imaging frequency, mean imaging charges per episode of care, and mean imaging charges for diagnostic imaging attributable to self- and radiologist-referral. RESULTS: Depending on the clinical presentation, self-referral resulted in 1.7 to 7.7 times more frequent performance of imaging examinations than radiologist-referral (P < .01, all presentations). Within all physician specialties, self-referral uniformly led to significantly greater utilization of diagnostic imaging than radiologist-referral. Mean imaging charges per episode of medical care (calculated as the product of the frequency of utilization and mean imaging charges) were 1.6 to 6.2 times greater for self-referral than for radiologist-referral (P < .01, all presentations). When imaging examinations were performed--including those performed in both physicians' offices and hospital outpatient departments--mean imaging charges were significantly greater for radiologists than for self-referring physicians in seven of the clinical presentations (P < .01). This result is related to the high technical charges of hospital outpatient departments; in office practice, radiologists' mean charges for imaging examinations were significantly less than those of self-referring physicians for seven clinical presentations (P < .01). CONCLUSIONS: Nonradiologist physicians who operate diagnostic imaging equipment in their offices perform imaging examinations more frequently, resulting in higher imaging charges per episode of medical care. These results extend our previous research on this subject by their focus on a broader range of clinical presentations; a mostly elderly, retired population; and the inclusion of higher-technology imaging examinations.

Aged↗
PubMed2005

Reactivity of genotypically distinct hepatitis B virus surface antigens in 10 commercial diagnostic kits available in Japan.

Hepatitis B virus (HBV) surface antigen (HBsAg) is one of the most important serological markers of current HBV infection. However, there are significant antigenic variations of HBsAg caused by genotypic diversity as well as mutation of the HBV genome. It is predictable that amino acid substitutions occurring in the HBsAg "a" determinant of a particular HBV genotype will affect the sensitivity of some diagnostic kits, since all the diagnostic kits currently available utilize monoclonal and/or polyclonal antibodies against the "a" determinant. One possible concern is that there may be a significant variation in the sensitivity of HBsAg diagnostic kits to HBsAg encoded by HBV of different genotypes, which might result in a failure to detect HBsAg of a particular HBV genotype. In this study, we assessed the reactivity of HBsAg specimens derived from three different HBV genotypes (A, B, and C) that are prevalent in Japan by 10 commercially available EIA (enzyme immunoassay), CLIA (chemiluminescent immunoassay), and CLEIA (chemiluminescent enzyme immunoassay) diagnostic kits. Specimens included both clinical samples and recombinant HBsAg. Our results showed that all the diagnostic kits evaluated were able to detect HBsAg irrespective of HBV genotypes. At the same time, it is apparent that some, but not all of the kits showed clear differences in sensitivity to the three HBV genotypes.

Genotype↗