Screening Test For Diabetes Mellitus Research Articles

Prevalence of Screening for Diabetes Mellitus in Patients Previously Diagnosed with Gestational Diabetes: Factors Related to its Performance.

To determine how many patients underwent screening for diabetes mellitus (DM) in the puerperium after a diagnosis of gestational DM (GDM) and which factors were related to its performance. The present is a prospective cohort study with 175 women with a diagnosis of GDM. Sociodemographic and clinico-obstetric data were collected through a questionnaire and a screening test for DM was requested six weeks postpartum. After ten weeks, the researchers contacted the patients by telephone with questions about the performance of the screening. The categorical variables were expressed as absolute and relative frequencies. The measure of association was the relative risk with a 95% confidence interval (95%CI), and values of p ≤ 0.05 were considered statistically significant and tested through logistic regression. The survey was completed by 159 patients, 32 (20.1%) of whom underwent puerperal screening. The mean age of the sample was of 30.7 years, and most patients were white (57.9%), married (56.6%), and had had 8 or more years of schooling (72.3%). About 22.6% of the patients used medications to treat GDM, 30.8% had other comorbidities, and 76.7% attended the postnatal appointment. Attendance at the postpartum appointment, the use of medication, and the presence of comorbidities showed an association with the performance of the oral glucose tolerance test in the puerperium. The prevalence of screening for DM six weeks postpartum is low in women previously diagnosed with GDM. Patients who attended the postpartum consultation, used medications to treat GDM, and had comorbidities were the most adherent to the puerperal screening. We need strategies to increase the rate of performance of this exam.

Screening strategy for gestational diabetes mellitus in a rural health setting in Kanpur (UP)

Introduction: Gestational Diabetes Mellitus (GDM) is defined as carbohydrate intolerance with its onset or diagnosis in pregnancy. Changing lifestyle and food habits are largely responsible for increasing incidence of Diabetes Mellitus, especially, in younger age groups. The same increasing trend is being observed in gestational diabetes mellitus. Treatment of GDM improves perinatal as well as maternal outcome. Timely diagnosis of GDM may result in reduced maternal and neonatal morbidity. The high risk pregnancies due to GDM contribute highly towards poor maternal and fetal outcome. GDM is one of the major causes for increased incidence of Macrosomia and primary Cesarean section abnormal 75-g GTT results show strong correlation with macrosomia. Materials and Methods: The sample size was calculated using the formula for comparing the means of two groups, using the results of Boyd, R. Leigh, B. and Stuart, P. as preliminary estimate for the average difference in mean capillary and venous blood sugar. A sample of 60 ANC cases has been studied as per inclusion and exclusion criteria. Aim and Objectives: Improvement in the diagnostic ability of the screening test for Diabetes Mellitus by comparing the commonly used method of using RBS with fasting 2hr GTT. Result: The mean age was found to be 27.75 ± 4.31 years. Mean Gestational age of the cases was 27.53 ± 7.29 Weeks. Mean OGTT (fasting) has been found to be statistically significantly higher than their RBS (‘t’ = 5.731 p < 0> Conclusion: A new strategy for using fasting OGTT as screening test has amongst ANC cases of rural population been suggested. Keywords: Screening, GDM, RBS, 2 hour OGTT.

Positivity thresholds of HbA1c assay as a screening test for diabetes mellitus in the first trimester in high-risk populations

Objective Both gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) are associated with increased risks of preeclampsia, macrosomia, shoulder dystocia, and irreversible brachial plexus injury (BPI). Compared to the conventional second trimester oral glucose tolerance test (OGTT), screening with the HbA1c assay in the first trimester with a diagnostic second trimester OGTT has been shown to diagnose more cases of T2DM and GDM earlier. Our study examined the effect of treatment based on varied positivity thresholds in high-risk pregnancies. Study design A decision analysis model was created using TreeAge 2016 software to compare the outcomes of screening with an HbA1C in the first trimester verses no first trimester screening, with positivity thresholds ranging from 5.9 to 6.4%. Outcomes examined included neonatal mortality, preeclampsia, preterm delivery, cerebral palsy, macrosomia, permanent BPI, cost, and quality adjusted life years (QALYs) of the mother and neonate. Probabilities, utilities, and costs were derived from the literature, and a cost-effectiveness threshold was set at $100,000/QALY. Univariate analyses were used to investigate the impact of screening positivity. Results First trimester screening was not cost-effective with an incremental cost effectiveness ratio of 5.87 when compared to screening with a positivity threshold of 6.4%. In a theoretical cohort of one million pregnancies, a screening threshold of 5.9% was the most cost-effective strategy. This strategy resulted in 2.999 million more QALYs, one less neonatal death, 346 fewer cases of preeclampsia, 66 less preterm deliveries, one less instance of cerebral palsy, and 615 fewer cases of macrosomia with nine less PBI cases. The 5.9% threshold provided an overall cost savings of $29.72 million. Conclusions Screening for diabetes in high risk pregnancies with the HbA1c assay in the first trimester is not cost effective compared to no screening; however, if screening is preformed, 5.9% should be used as the positivity threshold for diagnosis and treatment. Brief rationale With the increasing prevalence of diabetes mellitus among high-risk women in the USA, screening during pregnancy has become more important than ever. As a laboratory test, the HbA1c is relatively simple to obtain clinically, inexpensive, and its use has been well documented in the diagnosis and management of diabetes. However, there is limited data on its use in pregnancy and in particular during the first trimester. We sought to characterize the cost-effectiveness of screening with an HbA1c assay at various positivity thresholds for gestational diabetes mellitus and pre-existing type 2 diabetes in high-risk pregnancies in the first trimester. We found that this screening strategy is not cost-effective compared to no HbA1c in the first trimester and traditional oral glucose tolerance testing in the late second trimester. However, if screening is preformed, a positivity threshold of 5.9% should be used as the positivity threshold for diagnosis and treatment as it is associated with the best outcomes.

Annals for Educators - 7 August 2018.

Annals for Educators - 7 August 2018.

Clinical Implications of Using Post-Challenge Plasma Glucose Levels for Early Diagnosis of Type 2 Diabetes Mellitus in Older Individuals.

BackgroundThe aim of this study was to explore the differences in the clinical characteristics and diagnostic rates of diabetes mellitus (DM) according to various criteria in different age groups and to evaluate the efficacy of each criterion for screening older patients.MethodsWe studied 515 patients and measured the fasting plasma glucose level (FPG), 2-hour plasma glucose level after the 75 g oral glucose tolerance test (2-hour postload glucose [2-h PG]), and glycosylated hemoglobin (HbA1c) for re-evaluation of hyperglycemia without a history of diabetes. Patients with newly diagnosed DM were grouped by age as younger (<65 years) or older (≥65 years).ResultsOlder patients had significantly lower HbA1c, FPG, and 2-h PG levels and a higher homeostatic level of pancreatic β-cell function compared with younger patients (P<0.001). The older group had the lowest diagnostic rate when using the FPG level (45.5%) and the highest diagnostic rate when using the 2-h PG level (84.6%). These results were mostly due to the higher frequency of isolated post-challenge hyperglycemia in the older patients than in the younger group (28.8% vs. 9.2%). The use of both the FPG and HbA1c levels significantly enhanced the low diagnostic power when employing only the FPG levels in the older group (71.2% vs. 45.5%).ConclusionIn the older patients, the 2-h PG level was the most accurate diagnostic criterion. When we consider the costs and convenience, a combination of the FPG and HbA1c criteria may be recommended as a screening test for DM in older people.

Racial disparities in the utilization of preventive health services among older women with early-stage endometrial cancer enrolled in Medicare.

To assess differences in the receipt of preventive health services by race/ethnicity among older women with endometrial cancer enrolled in Medicare, we conducted a retrospective population‐based cohort study of women diagnosed with endometrial cancer from 2001 to 2011 in the Surveillance Epidemiology and End Results (SEER)‐Medicare database. Women with stage I or II endometrial cancer of epithelial origin were included. The exposure was race/ethnicity (Non‐Hispanic [NH] White, NH Black, Hispanic, and NH Asian/Pacific Islander [PI]). The services examined were receipt of influenza vaccination and screening tests for diabetes mellitus, hyperlipidemia, and breast cancer. We used multivariate logistic regression to estimate odds ratios with 95% confidence intervals (CI) adjusted for age, region, and year of diagnosis. A total of 13,054 women were included. In the 2 years after diagnosis, receipt of any influenza vaccine ranged from 45% among NH Black women to 67% among NH White women; receipt of a mammogram ranged from 65% among NH Black women to 74% among NH White women. Relative to NH White women, NH Black women had a lower likelihood of receiving both influenza vaccination (adjusted odds ratio [aOR] 0.40, 95% CI 0.33–0.44) and screening mammography (aOR 0.64, 95% CI 0.52–0.79). Hispanic women also were less likely to receive influenza vaccination than NH White women (aOR 0.61, 95% CI 0.51–0.72). There were no significant differences across racial groups for diabetes or cholesterol screening services. Among older women with early‐stage endometrial cancer, racial disparities exist in the utilization of some preventive services.

Validation of a nomogram for predicting regression from impaired fasting glucose to normoglycaemia to facilitate clinical decision making.

In Hong Kong, fasting plasma glucose (FPG) is the most popular screening test for diabetes mellitus (DM) in primary care. Individuals with impaired fasting glucose (IFG) are commonly encountered. To explore the determinants of regression to normoglycaemia among primary care patients with IFG based on non-invasive variables and to establish a nomogram for the prediction of regression from IFG. This cohort study consisted of 1197 primary care patients with IFG. These subjects were invited to repeat a FPG test and 75-g 2-hour oral glucose tolerance test (2h-OGTT) to determine the glycaemia change. Normoglycaemia was defined as FPG <5.6 mmol/L and 2h-OGTT <7.8 mmol/L. Stepwise logistic regression model was developed to predict the regression to normoglycaemia with non-invasive variables, using a randomly selected training dataset (810 subjects). The model was validated on the remaining testing dataset (387 subjects). Area under the receiver operating characteristic curve (AUC) and Hosmer-Lemeshow test were used to evaluate discrimination and calibration of the model. A nomogram was constructed based on the model. After a mean follow-up period of 6.1 months, 180 subjects (15.0%) had normoglycaemia based on the repeated FPG and 2h-OGTT results at follow-up. Subjects without central obesity or hypertension, with moderate-to-high-level physical activity and a lower baseline FPG level, were more likely to regress to normoglycaemia. The prediction model had acceptable discrimination (AUC = 0.705) and calibration (P = 0.840). The simple-to-use nomogram could facilitate identification of subjects with low risk of progression to DM and thus aid in clinical decision making and resource prioritization in the primary care setting.

Agreement of Point-of-Care Capillary Glycated Hemoglobin Levels with Conventional Screening Tests for Diabetes Mellitus in a Canadian First Nations Population.

1) How closely do capillary glycated hemoglobin (A1C) levels agree with venous A1C levels? 2) How well do venous A1C levels agree with plasma glucose for diagnosis of diabetes in this population? The Seabird Island mobile diabetes clinic screened people not known to have diabetes by using finger-prick capillary A1C levels with point-of-care analysis according to the Siemens/Bayer DCA 2000 system. Clients then went to a clinical laboratory for confirmatory testing for venous A1C levels, fasting plasma glucose (FPG) and plasma glucose 2 hours after 75 g oral glucose load (2hPG). A reference laboratory compared the DCA 2000 and the clinical laboratory's Roche Integra 800CTS system to the National Glycohemoglobin Standardization Program Diabetes Control and Complications Trial (DCCT) reference. 1) In the reference laboratory, DCA 2000 and Integra 800CTS both agreed very closely with the DCCT standard. In the field, capillary glycated hemoglobin percent (A1C) % was biased, underestimating venous A1C % by a mean of 0.19 (p<0.001). The margin of error of bias-adjusted capillary A1C % was ±0.36 for 95% of the time, compared to ±0.27 for venous A1C%. 2) By linear regression, we found FPG 7.0 mmol/L and 2hPG 11.1 mmol/L predicted mean venous A1C levels very close to 6.5%, with no significant bias. Point-of-care capillary A1C did not perform as well in the field as in the laboratory, but the bias is correctible, and the margin of error is small enough that the test is clinically useful. In this population, venous A1C levels ≥6.5% agree closely with the FPG and 2hPG thresholds to diagnose diabetes; ethnic-specific adjustment of the venous A1C threshold is not necessary.

Glycated albumin as a diagnostic tool for diabetes in a general Japanese population

ObjectiveDiabetes mellitus is a major cause of cardiovascular, kidney, neurologic, and eye diseases, and may be preventable in some cases by lifestyle modification. Screening tests for diabetes mellitus include fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c). Our objective was to evaluate the utility of plasma glycated albumin (GA) in the diagnosis of diabetes mellitus. Design and methodsA cross-sectional, community-based population study of 908 non-diabetic Japanese residents was conducted. Of these subjects, 176 with FPG value between 5.5 and 6.9mmol/l, and an HbA1c level of <6.5% received an oral glucose tolerance test (OGTT). ResultsThe OGTT results were used for the diagnosis of diabetes mellitus using World Health Organization criteria. Receiver operating characteristic (ROC) analyses demonstrated that optimal threshold values for the diagnosis of diabetes in this population were 15.2% for GA and 5.9% for HbA1c, respectively. Using these cutoff levels, the sensitivity of GA at 62.1% for detecting diabetes was the same as that of HbA1c. However the specificity for GA for detecting diabetes was 61.9%, while for HbA1c it was higher at 66.7%. ConclusionsOur results indicate that the measurement of glycated albumin may serve as a useful screening test for diabetes in a general Japanese population.

Screening for Type 2 diabetes mellitus using gingival crevicular blood with self monitoring blood glucose meter

BackgroundThe number of people with Type 2 diabetes mellitus is increasing globally and there is a large group of undiagnosed diabetes mellitus patients. Since the dental practitioners are extremely likely to encounter undiagnosed diabetes mellitus patients, they could play an important role in detecting diabetes in these patients to avoid long term macrovascular and microvascular complications. AimsTo compare the gingival crevicular blood glucose and fingerstick capillary blood glucose levels, and to evaluate the ability of gingival crevicular blood to be used as non-invasive screening test for diabetes mellitus. Material and methods60 patients with chronic periodontitis were recruited for the study. 30 patients were non-diabetic healthy controls and 30 were Type 2 diabetic patients. The gingival crevicular blood and fingerstick capillary blood were evaluated for blood glucose levels by using the Onetouch Ultra blood glucose self monitoring system. Linear relationship between gingival crevicular blood glucose and fingerstick blood glucose were assessed by Pearson's correlation analysis. ResultsA high degree of intra patient correlation was observed between gingival crevicular blood glucose and fingerstick capillary blood glucose in both non-diabetic (r = 0.88) and diabetic group (r = 0.94). There was no significant difference observed between Type 2 diabetic and non-diabetic patients with regard to age, gender, probing pocket depth and clinical attachment level. ConclusionsThe results of this study indicate that gingival crevicular blood can be used for screening of Type 2 diabetes mellitus. However, further studies are needed to confirm these findings with a larger sample size.

The prognostic value of a normal oral glucose tolerance test in pregnant women who tested positive at screening: a validation study.

BackgroundControversies surround a diagnosis of gestational diabetes mellitus (GDM). The objective of this study was to evaluate the oral glucose tolerance test (OGTT) for the prediction of adverse gestational and perinatal outcomes in pregnant women with a positive screening test for diabetes mellitus and a negative diagnosis, i.e. a normal 3-hour OGTT.MethodsThis validation study evaluated 409 pregnant women who tested positive for diabetes mellitus at screening. Perinatal and maternal outcomes were considered. Sensitivity and specificity were calculated for each of the values of the OGTT as a diagnostic test, with the gold standard being perinatal outcome.ResultsThe most frequent risk factors were obesity, arterial hypertension and advanced maternal age. The most common neonatal outcomes were large-for-gestational-age infants, Cesarean delivery and preterm birth. A fasting blood glucose level of 87 mg/dL was the most powerful predictor of adverse perinatal outcome.ConclusionsAt the cut-off level adopted by the American Diabetes Association, gestational OGTT was able to successfully identify in which pregnant women outcome would be unfavorable.

Prevalence of diabetes mellitus and the performance of a risk score among Hindustani Surinamese, African Surinamese and ethnic Dutch: a cross-sectional population-based study

BackgroundWhile the prevalence of type 2 diabetes mellitus (DM) is high, tailored risk scores for screening among South Asian and African origin populations are lacking. The aim of this study was, first, to compare the prevalence of (known and newly detected) DM among Hindustani Surinamese, African Surinamese and ethnic Dutch (Dutch). Second, to develop a new risk score for DM. Third, to evaluate the performance of the risk score and to compare it to criteria derived from current guidelines.MethodsWe conducted a cross-sectional population based study among 336 Hindustani Surinamese, 593 African Surinamese and 486 Dutch, aged 35–60 years, in Amsterdam. Logistic regressing analyses were used to derive a risk score based on non-invasively determined characteristics. The diagnostic accuracy was assessed by the area under the Receiver-Operator Characteristic curve (AUC).ResultsHindustani Surinamese had the highest prevalence of DM, followed by African Surinamese and Dutch: 16.7, 8.1, 4.2% (age 35–44) and 35.0, 19.0, 8.2% (age 45–60), respectively. The risk score included ethnicity, body mass index, waist circumference, resting heart rate, first-degree relative with DM, hypertension and history of cardiovascular disease. Selection based on age alone showed the lowest AUC: between 0.57–0.62. The AUC of our score (0.74–0.80) was higher than that of criteria from guidelines based solely on age and BMI and as high as criteria that required invasive specimen collection.ConclusionIn Hindustani Surinamese and African Surinamese populations, screening for DM should not be limited to those over 45 years, as is advocated in several guidelines. If selective screening is indicated, our ethnicity based risk score performs well as a screening test for DM among these groups, particularly compared to the criteria based on age and/or body mass index derived from current guidelines.

Fructosamine and glycated hemoglobin in the assessment of glycaemic control in dogs.

Fructosamine and glycated hemoglobin (HbA1c) concentrations were measured simultaneously in 222 dogs (96 healthy and 126 sick dogs). The dogs were divided into 3 groups according to the glucose concentration: hypo, hyper and euglycaemic dogs. Serum fructosamine concentrations were measured by the reduction test with nitroblue tetrazolium. A turbidimetric inhibition immunoassay and specific polyclonal antibodies were used to evaluate glycated hemoglobin concentrations. A significant correlation was found between glucose concentration and either fructosamine (r = 0.63, p < 0.0001) or glycated hemoglobin (r = 0.82, p < 0.0001). The correlation was higher in hyperglycaemic dogs for fructosamine (r = 0.80, p < 0.0001) and in hypoglycaemic dogs for glycated hemoglobin (r = 0.91, p < 0.005). We found a significant correlation between serum fructosamine and glycated hemoglobin (r = 0.65, p < 0.0001 ) when all the dogs were studied. A significant correlation was observed between serum fructosamine and glycated hemoglobin only in hyperglycaemic dogs (r = 0.82, p < 0.0003). Thus, fructosamine and HbA1c may be considered for use in screening tests for diabetes mellitus in dogs and clinical tests for monitoring control and evaluation of the diabetic animal's response to treatment. The choice of the analytical assay depends on the characteristic and analytical opportunities of the laboratory, as well as the number of serum samples to be analysed.

Compound Heterozygosity for β+-Thalassemia [-31 (A→G)] and a New Variant with Low Oxygen Affinity, Hb Sagami [β139(H17)Asn→Thr

A new hemoglobin (Hb) variant, Hb Sagami [β139(H 17)Asn→Thr] was accidentally found through the assay of Hb A1c by high performance liquid chromatography (HPLC) in a screening test for diabetes mellitus (1). The amino acid substitution was determined by electrospray ionization mass spectrometry (ESI/MS) and confirmed by an automatic protein sequencer (1). The content of the abnormal β chain was about twice that of normal β chain, which was estimated by ESI/MS with intact globin mixture, and by high-resolution ion exchange column chromatography (PolyCAT A; Poly LC, Columbia, MD, USA) with Hb.

Evaluation of fasting plasma glucose as a screening test for diabetes mellitus in Singaporean adults.

To assess the performance of different cutoff points for fasting plasma glucose (FPG) including the World Health Organization (WHO) cutoff of FPG > and = 7.8 mmol l-1 for the screening of diabetes mellitus, data from oral glucose tolerance tests done on 865 Singaporean adults over a 4-year period were analysed. The relationship between FPG and 2 h post-load plasma glucose (2H-PG) was determined using regression analysis and receiver operating characteristic (ROC) analysis. Out of 220 subjects with 2H-PG exceeding 11.1 mmol l-1, only 90 had FPG exceeding 7.8 mmol l-1, yielding a sensitivity of only 40.9%. The relationship between FPG and 2H-PG was non-linear and conformed to a cubic equation [FPG = 3.0890 + 0.0272 (2H-PG)2 - 0.0006 (2H-PG)3]. ROC analysis determined an FPG of 5.7 mmol l-1 to yield optimal sensitivity and specificity. Although in the clinical setting, FPG is an extremely useful screening test for diabetes, it is clear, as has been shown in other studies, that the traditional WHO criterion of FPG > and = 7.8 mmol l-1 is highly insensitive for detecting diabetes. Lower FPG cutoffs achieve greater sensitivity albeit at the expense of reduced specificity. Although ROC analysis in this population determines the optimally sensitive and specific FPG cutoff to be 5.7 mmol l-1, we suggest that the FPG cutoff should be adjusted to 7.0 mmol l-1 for preservation of specificity.

A GENERALIZED LINEAR MODEL FOR ANALYSING RECEIVER OPERATING CHARACTERISTIC CURVES

We present a continuation ratio model for analysing ordinal categorical data and we apply the model to the problem of estimating receiver operating characteristic (ROC) curves. We apply the methods to post-prandial capillary blood glucose measurements as a criterion for a potential screening test for diabetes mellitus. One can obtain point estimates of sensitivity and specificity and their associated standard errors at any value along the observed range of post-prandial capillary blood glucose measurements. Also, in comparison to the models for ROCs described by Tosteson and Begg, ROC curves based on the continuation ratio model have the desired features that allow ROCs to be concave but not necessarily symmetric.

Improving the Accuracy of Screening Tests for Diabetes Mellitus with a Logistic Regression Model

Improving the Accuracy of Screening Tests for Diabetes Mellitus with a Logistic Regression Model

Standardization of the screening test for diabetes mellitus using glycated hemoglobin

Standardization of the screening test for diabetes mellitus using glycated hemoglobin

Random capillary whole blood glucose test as a screening test for diabetes mellitus in a middle-aged population.

This study was aimed at assessing the adequacy of a random capillary whole blood glucose (RCBG) test as a screening test for diabetes mellitus in a middle-aged (55-year-old) Finnish population. Both the screening test (RCBG) and a standard 2-h oral glucose tolerance test (OGTT) were performed on all the participants according to the WHO criteria. The prevalence based on the 2-h OGTTs was 8.5% (11.7% for men and 6.0% for women). The sensitivity, specificity and predictive values of the screening test for diabetes and the receiver operator characteristic (ROC) curves were studied. The likelihood ratios for diabetes within the test categories were also calculated. When a cut-off point of 6.2 mmol l-1 was used, which proved to be the most appropriate in the present study, the specificity was 92% and the sensitivity 63% (79% for men and 40% for women). The men had much higher sensitivities than the women at all cut-off points, but the specificities were comparable. The present study indicated that the RCBG test could be used as a screening test in a subpopulation with a high prevalence of diabetes and severe hyperglycaemia, but it would be quite insensitive in a subpopulation with a considerable overlap of RCBG values between the diabetic group and the non-diabetic one. It would be inappropriate to use the RCBG test as a routine screening test for diabetes in a general population, particularly among subjects with a known low prevalence of diabetes.

Random capillary whole blood glucose test as a screening test for diabetes mellitus in an elderly population

We assessed the adequacy of the random capillary whole blood glucose (RCBG) test as a screening test for estimating the prevalence of diabetes mellitus in an elderly Finnish population (aged 70 years or over). Both the screening test and a standard 2 h oral glucose tolerance test made according to the WHO criteria were administered to all participants. By using a cut-off point of 7.4 mmol/l for men, 7.1 mmol/l for women and 7.2 mmol/l for the total population, the RCBG test determined the prevalence of diabetes accurately. The prevalence determined by the RCBG test was 25.8% (men 21.0% and women 28.6%) and that determined by the 2 h oral glucose tolerance test 26.1% (men 21.7% and women 28.6%). The study also indicated that the RCBG levels elevated with the increase of the severity and duration of diabetes and with the presence of hypertension. The conclusion is that the RCBG test with a proper cut-off point is an optimal test for the estimation of the prevalence of diabetes and that the other properties of the test should be assessed according to the clinical outcomes and later signs of the disease.