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PubMed2001

Basic principles on selection and use of diagnostic tests: properties of diagnostic tests.

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 results of studies on the test; 2) diagnostic properties of the test; and 3) applicability of the test in the clinical setting. The rational use and the correct interpretation of diagnostic tests are based on these three factors. In a previous article we presented the basic principles concerning the validity of the results from the study that defined the specific test, and what level of evidence that constitutes. In this article we present the diagnostic properties of tests (sensitivity, specificity, positive and negative predictive values, likelihood ratios, odds). Finally, in a forthcoming paper we will discuss the applicability of the test in clinical cardiological practice.

Diagnostic Techniques and Procedures↗
PubMed2004

[Humor as an additional component of psychological and psychiatric diagnostics in children and adolescents: concept of a humor-diagnostic model].

When looking at humor of children and adolescents from a diagnostic point of view, there exist additional diagnostic possibilities other than the usual assessment methods from child and adolescent psychiatry or psychology. Spontaneous humorous behavior in everyday life and a humorous performance during assessment situations of children can provide a useful basis for further diagnostic considerations. From a developmental point of view it is important to notice what kinds of humor a child is already capable of understanding and of performing towards others. Whilst the actual readiness for cheerfulness contains information concerning the emotional state, the more general readiness for being cheerful renders insight into basic parameters of temperament. To what extent a child uses humor either supportively or destructively, contains information about psychodynamic connections, motivational aspects and active coping strategies. Concerning the diagnostic approach, reports of parents as well as humor tests or hypothesizing methods (e.g. humorous drawings) can be used. Central in using humor as a diagnostic assessment device is the knowledge of humor development and of the relations between psychiatric illnesses and humor.

Adaptation, Psychological↗
PubMed2005

From single cell gene-based diagnostics to diagnostic genomics: current applications and future perspectives.

Molecular diagnostics is a branch of clinical diagnostics that uses primarily DNA or RNA as a biomarker for clinical testing. It combines various gene-based amplification technologies with highly sophisticated detection methods for the clinical diagnosis of a vast variety of diseases including infectious diseases, cancer, and inherited diseases. The principal application of gene-based amplification technology is to identify pathogen or gene-specific nucleic acid sequences that are used as surrogate markers for the identification of either infectious pathogens or alteration of disease-related genes. There are generally three classes of gene-based amplification technologies: target-based, e.g., PCR; probe-based, e.g., LCR; and signal-based, e.g., bDNA. Real-time detection of PCR allows us to quantify amplified amplicons with a broad dynamic range and it offers a unique way to detect genetic mutations. Other technologies such as immuno-PCR and bio-barcode assay (BCA) combine different amplification tactics offering extreme detection sensitivity ranging from femtogram (10(-15)) to zeptogram (10(-21)). Even though quantum dots technology is in its infant stage, its potential to further increase diagnostic sensitivity and specificity is likely beyond our current imagination. Future diagnostic technologies include the use of genomic and proteomic approaches especially in pure cell types or even in the single-cell level, which open up endless new possibilities for gene-based diagnostics at entirely different levels. In this article, principles of various current gene-based amplification and detection technologies along with their clinical applications are discussed. New technologies that could potentially be used in future gene-based diagnosis are introduced.

Genetics, Medical↗
PubMed2006

Atypical foci suspicious but not diagnostic of malignancy in prostate needle biopsies (also referred to as "atypical small acinar proliferation suspicious for but not diagnostic of malignancy").

OBJECTIVE: To review atypical focus suspicious but not diagnostic of malignancy in needle biopsies of the prostate, also referred to as "atypical small acinar proliferation suspicious for but not diagnostic of malignancy." METHODS: A number of descriptive and somewhat confusing terms have been used to refer to a prostate tissue biopsy with small focus of atypical glands. Based on MEDLINE database searches, all aspects, including the synonymous terms, of atypical focus suspicious but not diagnostic of malignancy were examined. RESULTS: An average of 5% of needle biopsy pathology reports show a diagnosis of atypical focus suspicious for malignancy. It may be composed of acini of small size, that is, smaller than normal ducts and acini, but may also include glands with a diameter similar to that of normal ducts and acini. It encompasses a variety of lesions, including benign mimickers of cancer and small foci of carcinoma that, for a variety of reasons, cannot be accurately diagnosed. Maximal diagnostic information should be gained on section stained with haematoxylin and eosin, with immunohistochemical stains used for confirmation. Its presence in a biopsy set is a strong predictor for concurrent or subsequent adenocarcinoma. The values range from 17% to 60%, the mean being 40.7%. The precise labelling of the initial biopsies is mandatory so that rebiopsy of patients with atypical foci can be directed in a more concentrated fashion into the region of the initial biopsy. CONCLUSION: The presence of atypical focus suspicious but not diagnostic of malignancy in needle biopsies is an important predictor of cancer compared with biopsies from patients who lack this finding.

Biopsy, Needle↗
PubMed1996

Diagnostic accuracy of direct digital dental radiography for the detection of periapical bone lesions. II. Effects on diagnostic accuracy after application of image processing.

OBJECTIVES: The diagnostic accuracy of direct digital radiography for the detection of small experimentally made periapical lesions was evaluated. A comparison was made between original digital images and images processed with different enhancement facilities of the digital system. STUDY DESIGN: Seven observers assessed the digital images in original mode and after individual image treatment. The diagnostic accuracy was calculated. The processing functions used by the observers were recorded, and the effect of processing was evaluated. RESULTS: The overall diagnostic accuracy was not different for the two image modes. Neither were the individual results of the observers different. The image processing was most effective when alterings of contrast and brightness were used. More complicated processing procedures had less effect on the diagnostic accuracy. CONCLUSIONS: Image processing of direct digital images of high quality has a limited effect on the diagnostic accuracy. Basic processing functions, that is, alterings of contrast and brightness, were preferred for the detection of periapical lesions.

Alveolar Bone Loss↗
PubMedDate not supplied

Should diagnostic hysteroscopy be a routine procedure during diagnostic laparoscopy in women with normal hysterosalpingography?

The advantage of hysteroscopy (HSC) over hysterosalpingography (HSG) in the accuracy of the diagnosis of uterine cavity abnormalities that may cause or contribute to infertility has been shown by numerous studies. The aim of this study was to analyse the results obtained from diagnostic HSC performed routinely during diagnostic laparoscopy in the investigation of the infertile women, to evaluate the effectiveness of the procedure in the diagnosis of uterine causes of female infertility. Ninety-three infertile patients with normal uterine cavity as demonstrated in HSG underwent diagnostic laparoscopy and hysteroscopy in this infertility unit. The hysteroscopy showed a normal cavity in 80 cases (88%), giving a false-negative rate of 12% for HSG. The pathologies found included small adhesions (two cases), an arcuate fundus (two cases), an endometrial polyp (three cases), and endometrial hyperplasia was diagnosed in four cases. In the absence of a positive history or a radiographical suggestion of endometrial abnormalities, or both, HSC made little diagnostic contribution towards elucidating the cause of female infertility or to finding a pathology that could affect the chances of achieving a normal pregnancy. However, in view of the low complication rates, minimal time requirement, and a negligible effect on the post-operative course, HSC could be performed on all infertile patients undergoing diagnostic laparoscopy.

Female↗
PubMed1996

Diagnostic accuracy and confusability analyses: an application to the Diagnostic Interview for Genetic Studies.

The dominant, contemporary paradigm for developing and refining diagnoses relies heavily on assessing reliability with kappa coefficients and virtually ignores a core component of psychometric practice: the theory of latent structures. This article describes a psychometric approach to psychiatric nosology that emphasizes the diagnostic accuracy and confusability of diagnostic categories. We apply these methods to the Diagnostic Interview for Genetic Studies (DIGS), a structured psychiatric interview designed by the NIMH Genetics Initiative for genetic studies of schizophrenia and bipolar disorder. Our results show that sensitivity and specificity were excellent for both DSM-III-R and RDC diagnoses of major depression, bipolar disorder, and schizophrenia. In contrast, diagnostic accuracy was substantially lower for subtypes of schizoaffective disorder-especially for the DSM-III-R definitions. Both the bipolar and depressed subtypes of DSM-III-R schizoaffective disorder had excellent specificity but poor sensitivity. The RDC definitions also had excellent specificity but were more sensitive than the DSM-III-R schizoaffective diagnoses. The source of low sensitivity for schizoaffective subtypes differed for the two diagnostic systems. For RDC criteria, the schizoaffective subtypes were frequently confused with one another; they were less frequently confused with other diagnoses. In contrast, the DSM-III-R subtypes were often confused with schizophrenia, but not with each other.

Bipolar Disorder↗
PubMed2005

[Diagnostic assessment of painless microhematuria: prospective study comparing image quality, assessibility and diagnostic certainty of multidetector-row CT and intravenous pyelography within a single examination].

PURPOSE: The purpose of this study is to prospectively compare intravenous pyelography (IVP) and combined unenhanced and excretory phase multidetector-row CT (MDCT) with respect to image quality, diagnostic certainty and diagnostic concordance with the final clinical diagnosis in patients with painless microhematuria. MATERIALS AND METHODS: Unenhanced MDCT, IVP and excretory phase MDCT were performed in 59 consecutive patients (21 women, 38 men, mean age 56 +/- 19 years, range 23 - 83 years) with painless microhematuria of unknown origin during a single examination with a single contrast media application (100 ml, non-ionic iodinated contrast media). Images were assessed by two experienced urogenital radiologists in consensus for image quality, diagnostic certainty of stone detection, obstruction, parenchymal lesions and morphological distinctive features. Imaging diagnoses of MDCT and IVP were compared with the final clinical diagnoses. In case of failure to detect an relevant pathology, the final clinical diagnosis was established after a mean follow-up period of 18 +/- 6 months (10 months to 2 years). Costs and radiation exposure of IVP and MDCT were compared. RESULTS: MDCT scan performed better than IVP in terms of image quality for all regarded variables. Image quality of MDCT was rated in all parameters as very good or good; the image quality of IVP differed in a wide range. MDCT and IVP reached a sensitivity of 100 % and 50 % for stone detection (n = 14, p = 0.008), respectively. Two bladder stones were not detected by IVU but correctly seen with MDCT. MDCT and IVP were unsatisfactory for detecting transitional cell carcinomas (n = 4, 2 of 4 detected with MDCT, 0 of 4 detected with IVU). One false positive transitional cell carcinoma was detected with IVP, none with MDCT. Additional relevant pathological changes (one teratoma, one abdominal aortic aneurysma and one abscess) were detected using MDCT but missed with IVP. In 38 of 59 patients (64 %) imaging and clinical follow-up over up to 24 months did not reveal any pathology to explain the microhematuria. The costs of the IVP (283 Euro) were lower compared with non-enhanced MDCT (380 Euro) or combined non-enhanced and contrast-enhanced MDCT (560 Euro). The radiation exposure was 23 - 27 mSv for MDCT and 2.3 mSv for IVP. CONCLUSION: MDCT performed better regarding image quality, subjective diagnostic certainty and diagnostic results with respect to stone detection. Since urolithiasis is a frequent cause of painless microhematuria MDCT is recommended as the initial imaging modality rather than IVU.

Adult↗
PubMedDate not supplied

Elementary school-age children's capacity to choose positive diagnostic and negative diagnostic tests.

Two experiments involving 72 elementary school-age children (mean age = 10 years, 3 months, range = 9,4-11,8) and 72 adults compared the ability of participants to choose positive and negative diagnostic tests over positive and negative nondiagnostic tests. Both experiments employed novel test materials, which resolved any issues regarding the effects of context on test strategy employment. In Experiment 1, both children and adults were significantly more likely to prefer positive diagnostic tests over positive nondiagnostic tests; however, only adults demonstrated a significant preference for negative diagnostic tests over positive nondiagnostic ones. In Experiment 2, both children and adults were more likely to choose negative diagnostic tests over negative nondiagnostic tests, demonstrating that despite a strong positive test bias, children could reason diagnostically in selecting among negative tests in cases in which only negative test choices were available.

Affect↗
PubMed2000

Diagnostic values of clinical diagnostic tests in subacromial impingement syndrome.

OBJECTIVE: Subacromial impingement syndrome (SIS) is a frequent cause of shoulder pain. The aim of this study was to investigate the diagnostic values of clinical diagnostic tests, in patients with SIS. METHODS: 72 female, 48 male patients with shoulder pain were included in the study. Five had bilateral shoulder pain, so 125 painful shoulders were evaluated. Details were recorded about the patients' ages and sexes, as well as characteristics of pain and related problems. Detailed physical examination and routine laboratory tests were performed. Conventional radiography and subsequent magnetic resonance imaging of the shoulder region of all patients were performed. Patients were divided into two groups according to the results of subacromial injection test, a reference standard test for SIS. Test positive patients constituted SIS group and test negative patients the non-SIS group. Sensitivity, specificity, accuracy, positive and negative predictive values of some clinical diagnostic tests such as Neer, Hawkins, horizontal adduction, painful arc, drop arm, Yergason and Speed tests for SIS were determined by using 2 x 2 table. RESULTS: The most sensitive diagnostic tests were found to be Hawkins test (92.1%), Neer test (88.7%) and horizontal adduction test (82.0%). Tests with highest specificity were drop arm test (97.2%), Yergason test (86.1%) and painful arc test (80.5%) consecutively. CONCLUSION: The highly sensitive tests seem to have low specificity values and the highly specific ones to have low sensitivity values. Although this finding suggests that these diagnostic tests are insufficient for certain diagnosis, it is suggested they play an important part in clinical evaluation.

Adult↗
PubMed1989

Diagnostic interviewing with children: the use and reliability of the diagnostic coding form.

There have been few attempts to standardize assessment methods in Child Psychiatry. This paper describes a semi-structured approach to diagnostic interviewing of the child. Thirty-four children six to 13 years of age, and their parents, were interviewed two weeks apart by two different psychiatrists. A diagnostic coding form consisting of 29 clinical symptom items, eight summary items, and nine positive health ratings was used. Three diagnostic items were also included: "severity of clinical condition," "probability of disorder," and "adjustment status." Twelve of the Time 2 interviews with the child and parent were videotaped and rated by three different psychiatrists. Results indicated that summary items had higher reliability than individual symptom items and the three diagnostic items had the highest reliability, suggesting reliability is better for broad classes of behaviour. Interrater reliability was higher for the face-to-face rating than videotaped ratings. This suggests first that face-to-face interviews are reasonably stable over a two week period and second, since videotaped ratings had lowest reliability on items that depended on inferences about the child's feedlings, an important source of variance in assessment may be the clinician's ability to empathize with the child and draw inferences about internal feeling-states. It was concluded that this interview schedule can be a part of routine clinical practice. It ensures a reasonably standard, yet flexible and reliable approach to diagnostic interviewing.

Adaptation, Psychological↗
PubMed2003

[Study of diagnostic criteria of acute respiratory distress syndrome and multiple organ dysfunction syndrome at high altitude: revised draft of the diagnostic criteria of high acute respiratory distress syndrome drawn in Lanzhou conference].

OBJECTIVE: To compare the difference of the diagnostic parameters of acute respiratory distress syndrome/multiple organ dysfunction syndrome (ARDS/MODS) at high altitude (H-ARDS/MODS) with that on plains and reevaluate the practicality and feasibility of the diagnostic criteria of H-ARDS (Lanzhou conference, 1999). METHODS: Three hundred and sixty cases with relatively complete data were divided into three groups according to their originating altitude: control group on plains (CG, n=93), high altitude group 1 at the altitude of 1,517 m (H1G, n=223), high altitude group 2 at the altitude of 2,261-2,400 m (H2G, n=44). The ARDS/MODS scorings of the three groups were carried out according to the diagnostic criteria of Lushan Conference, Marshall (1995) and Lanzhou criteria drafted by the authors and the receiver operating characteristic curves (ROC curve) were made to predict the outcome of MODS. RESULTS: In CG group, the area of ROC, the susceptibility and specificity were 0.823, 0.833, 0.731, respectively according to Lushan criteria, which were better than those (0.815, 0.767, 0.763) according to Marshall criteria. Then in group H2G, the area of ROC, the susceptibility and specificity according to Lushan criteria were lower than those according to Marshall criteria: 0.855, 0.583, 0.969 vs 0.914, 1.000, 0.657. The optimum cutoff points of partial pressure of oxygen in artery (PaO(2))/fractional concentration of inspired oxygen (FiO(2)) were 198.32 mmHg, 131.50 mmHg and 97.58 mmHg in group CG, H1G and H2G. CONCLUSION: (1) There are significant differences between the diagnostic criteria of ARDS at high altitude and that on plains. The altitude of 1 517 m would be an important border line in diagnosing H-ARDS. (2) The drafted diagnostic criteria of ARDS at high altitude are feasible and practical in this region, but the range of the parameters is still wide, which need to be properly amended. (3) The changing tendency of the parameters of MODS at high altitude is different from that on plains, but the amount of sample needs to be accumulated further and the Lanzhou criteria needs to be perfected.

Age Factors↗
PubMed2004

Estimation of the diagnostic accuracy of organ electrodermal diagnostics.

OBJECTIVE: To estimate the diagnostic accuracy and the scope of utilisation of a new bio-electronic method of organ diagnostics. DESIGN: Double-blind comparative study of the diagnostic results obtained using organ electrodermal diagnostics (OED), with clinical diagnosis as the criterion standard. SETTING: Department of Surgery, Helen Joseph Hospital, Johannesburg. PATIENTS: Two hundred pre-selected inpatients of mean age 38 years (standard deviation 9 years) with suspected pathology of one (or more) of the following organs: oesophagus, stomach, gallbladder, pancreas, colon, kidneys, urinary bladder and prostate. In total, 714 of the abovementioned internal organs were selected for statistical consideration. MAIN OUTCOME MEASURES: The degree of rectification of the measuring current once the resistance 'breakthrough effect' has been induced in the skin, as well as the difference in impedance measured at organ projection areas (OPAs) (skin zones corresponding to particular internal organs). RESULTS: In total, 630 true OED results were obtained from the 714 subjects considered, with a detection rate of 88.2% (95% confidence interval (CI): 85.6 - 90.5%). Established OED sensitivity was 89.5% (CI: 85.2 - 92.8%) and OED specificity equalled 87.5% (CI: 84.0 - 90.4%). The predictive value for positive OED results was 81.7% (CI: 76.9 - 85.9%) and for negative OED results 93.0% (CI 90.1 - 95.2%). Healthy organs usually produced the OED result 'healthy' or 'within normal limits', while subacute pathology displayed 'subcute' and acute pathology 'acute'. The OED results were not affected by either the type or the aetiology of disease, i.e. OED estimated the actual extent of pathological process activity within particular organs but did not directly explain the cause of pathology. CONCLUSIONS: So-called OPAs do exist on the skin surface. Pathology of a particular organ causes a related OPA to rectify electrical currents once the resistance 'breakthrough effect' has been induced in the skin. Pathology of an internal organ also increases the impedance of the corresponding OPA. The degree of rectification or difference in impedance is proportional to the extent of the pathological process within this organ. OED which utilises the abovementioned electrical phenomena of the skin, is a reliable bio-electronic method of non-invasive medical diagnostics, with high rates of sensitivity, specificity and predictive values. OED may be used to detect diseased organs and estimate the extent of pathological process activity.

Adult↗
PubMed2003

[Reporting studies of diagnostic accuracy according to a standard method; the Standards for Reporting of Diagnostic Accuracy (STARD)].

The objective of the 'Standards for Reporting of Diagnostic Accuracy' (STARD) initiative is to improve the reporting of studies of diagnostic accuracy, so as to allow readers to assess the potential for bias in a study and to evaluate the generalibility of its results. The group searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies. This was used to draw up a list of potential items. During a consensus meeting, a group of researchers, medical journal editors, and members of professional organisations reduced this list to a usable checklist. Wherever possible, evidence from the literature was used to justify the decisions made. The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which a list of 75 potential items was extracted. At the consensus meeting, participants shortened the list to a 25-item checklist. A generic flow diagram was drawn up to provide guidance on the method for including patients, the order in which tests were to be conducted and the number of patients to undergo the test being evaluated, the reference standard, or both. A scientific publication can only be assessed when the reporting is both correct and complete. Use of the checklist and flow diagram will improve the quality of reports produced, to the advantage of clinicians, researchers, reviewers, journal editors and other interested parties.

Algorithms↗
PubMed2003

The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. The Standards for Reporting of Diagnostic Accuracy Group.

The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in a study and to evaluate the generalisability of the results. A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present. This explanatory document aims to facilitate the use, understanding and dissemination of the checklist. The document contains a clarification of the meaning, rationale and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability. The STARD statement, checklist, flowchart, and this explanation and elaboration document should be useful resources to improve the reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in health care.

Advisory Committees↗
PubMed1989

A diagnostic centre for general practitioners: results of individual feedback on diagnostic actions.

A diagnostic centre, managing diagnostic tests for general practice, can improve the service provided by primary health care and the communication between general practitioners and specialists. In addition, it can evaluate the use and misuse of tests. This paper describes the work of a diagnostic centre in the Netherlands serving 80 general practitioners. Following the introduction of individual feedback to general practitioners on their use of diagnostic tests there was a decrease in the number of requests for tests.

Adult↗
PubMed1998

Can helical CT replace scintigraphy in the diagnostic process in suspected pulmonary embolism? A retrolective-prolective cohort study focusing on total diagnostic yield.

The aim of our study was to compare the diagnostic value of helical CT vs that of ventilation-perfusion (V/Q) scintigraphy as a first-line test in a diagnostic strategy in patients suspected of pulmonary embolism (PE). In a retrolective-prolective cohort study we tested the accuracy of helical CT vs V/Q scintigraphy in 123 patients suspected of PE. A diagnostic panel was asked to formulate the presumptive diagnosis on the presence or absence of PE, or of alternative disease by using two competing diagnostic strategies. These consisted of the patient history, laboratory tests and chest X-ray (together baseline tests) in combination with either helical CT or V/Q scintigraphy (CT strategy and V/Q strategy, respectively). The results were compared with the final diagnosis in each patient that was established from various reference tests (which included V/Q scintigraphy, pulmonary angiography and clinical follow-up). The CT and V/Q strategies were compared with regard to the accuracy for PE, for alternative diseases and with regard to the proportion of conclusive diagnoses that were made. The CT strategy was more accurate than the V/Q strategy for detecting or excluding PE. Sensitivity and specificity were 49 and 74 % for the V/Q strategy and 75 and 90 % for the CT strategy, respectively (P = 0.01). The CT strategy provided a conclusive diagnosis in a significantly larger proportion of patients than the V/Q strategy, 92 vs 72 % (P < 0.001). The CT strategy detected more alternative diagnosis than the V/Q strategy, 93 vs 51 %, respectively (P < 0.001). Helical CT seems more useful than V/Q scintigraphy as a first-line test in patients suspected of PE.

Adult↗
PubMed2003

Comparison of the diagnostic sensitivity of a commercially available culture kit and a diagnostic culture test using Diamond's media for diagnosing Tritrichomonas foetus in bulls.

A number of different culture media have been described for use in the diagnosis of Tritrichomonas foetus infection in bulls, and recently, a commercial culture kit has become available. The objective of this study was to compare the sensitivity of 2 culture-based diagnostic tests for T. foetus in bulls. One test used a commercial kit for transport and culture of the samples. The other test used a thioglycollate transport medium (TFTM) for transport and a modified Diamond's medium (MDM) for culture of the samples. Twenty-one bulls infected with T. foetus were sampled repeatedly. On each sampling day, samples collected from the left and right sides of the bull were tested with one of the 2 diagnostic tests being compared. The effect of the type of diagnostic test on the outcome of the test was evaluated with a chi-square test for the calculated odds ratio. Because repeated tests from the same bull cannot be considered independent measures, unadjusted chi-square tests were adjusted for the effect of clustering by bull. Samples tested using the commercial kit were 6.95 times as likely to be positive as samples tested with a diagnostic test using MDM (P < 0.001).

Animals↗