Comparison of saliva with healthcare workers- and patient-collected swabs in the diagnosis of COVID-19 in a large cohort

Abstract Background A considerable amount of evidence demonstrates the potential of saliva in the diagnosis of COVID-19. Our aim was to determine the sensitivity of saliva versus swabs collected by healthcare workers (HCWs) and patients themselves to assess whether saliva detection can be offered as a cost-effective, risk-free method of SARS-CoV-2 detection. Methods This study was conducted in a hospital involving outpatients and hospitalized patients. A total of 3018 outpatients were tested. Of these, 200 qRT-PCR-confirmed SARS-CoV-2-positive patients were recruited for further study. In addition, 101 SARS-CoV-2-positive hospitalized patients with symptoms were also enrolled in the study. From outpatients, HCWs collected nasopharyngeal swabs (NPS), saliva were obtained. From inpatients, HCWs collected swabs, patient-collected swabs, and saliva were obtained. qRT-PCR was performed to detect SARS-CoV-2 by TAQPATH assay to determine the sensitivity of saliva detection. Sensitivity, specificity and positive/negative predictive values (PPV, NPV) of detecting SARS-CoV-2 were calculated using MedCalc. Results Of 3018 outpatients (asymptomatic: 2683, symptomatic: 335) tested by qRT-PCR, 200 were positive (males: 140, females: 60; aged 37.9 ± 12.8 years; (81 asymptomatic, 119 symptomatic). Of these, saliva was positive in 128 (64%); 39 of 81 asymptomatic (47%),89 of 119 symptomatic patients (74.8%). Sensitivity of detection was 60.9% (55.4–66.3%, CI 95%), with a negative predictive value of 36%(32.9–39.2%, CI 95%).Among 101 hospitalized patients (males:65, females: 36; aged 53.48 ± 15.6 years), with HCW collected NPS as comparator, sensitivity of saliva was 56.1% (47.5–64.5, CI 95%), specificity 63.5%(50.4–75.3, CI95%) with PPV of 77.2% and NPV of 39.6% and that of self-swab was 52.3%(44–60.5%, CI95%), specificity 56.6% (42.3–70.2%, CI95%) with PPV 77.2% and NPV29.7%. Comparison of positivity with the onset of symptoms revealed highest detection in saliva on day 3 after onset of symptoms. Additionally, only saliva was positive in 13 (12.8%) hospitalized patients. Conclusion Saliva which is easier to collect than nasopharyngeal swab is a viable alternate to detect SARS-COV-2 in symptomatic patients in the early stage of onset of symptoms. Although saliva is currently not recommended for screening asymptomatic patients, optimization of collection and uniform timing of sampling might improve the sensitivity enabling its use as a screening tool at community level.

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Comparison of Saliva with Healthcare Workers- and Patient-Collected Swabs in the Diagnosis of COVID-19 in a Large Cohort

10.21203/rs.3.rs-132301/v1 ◽

2020 ◽

Author(s):

Mitnala Sasikala ◽

Yelamanchili Sadhana ◽

Ketavarapu Vijayasarathy ◽

Anand Gupta ◽

Sarala kumari Daram ◽

...

Keyword(s):

Healthcare Workers ◽

Screening Tool ◽

Cost Effective ◽

Hospitalized Patients ◽

Detection Sensitivity ◽

Nasopharyngeal Swab ◽

Predictive Values ◽

Qrt Pcr ◽

Lower Detection ◽

Sensitivity Specificity

Abstract Background: A considerable amount of evidence demonstrates the potential of saliva in the diagnosis of COVID-19. Our aim was to determine the sensitivity of saliva versus swabs collected by healthcare workers (HCWs) and patients themselves to assess whether saliva detection can be offered as a cost-effective, risk-free method of SARS-CoV-2 detection.Methods: This study was conducted in a hospital involving outpatients and hospitalized patients. A total of 3018 outpatients (asymptomatic: 2683, symptomatic: 335) were screened. Of these, 200 qRT-PCR-confirmed SARS-CoV-2-positive patients were recruited (81 asymptomatic, 119 symptomatic). In addition, 101 SARS-CoV-2-positive hospitalized patients with symptoms were also enrolled in the study. From outpatients, HCWs collected nasopharyngeal swabs (NPS), saliva were obtained. From inpatients, HCWs collected swabs, patient-collected swabs, and saliva were obtained. qRT-PCR was performed to detect SARS-CoV-2 by TAQPATH assay to determine the sensitivity of saliva detection. Sensitivity, specificity and positive/negative predictive values (PPV, NPV) of detecting SARS-CoV-2 were calculated using MedCalc.Results: Of 3018 outpatient swabs tested by qRT-PCR, 200 were positive (males: 140, females: 60; aged 37.85±12.76 years). Of these, saliva was positive in 128 (64%); 39 of 81 asymptomatic (47%),89 of 119 symptomatic patients (74.78%). Sensitivity of detection was 60.9% (55.4-66.3%, CI 95%), with a negative predictive value of 36%(32.9-39.2%, CI 95%).Among 101 hospitalized patients (males:65, females: 36; aged 53.43±15.58 years), with HCW collected NPS as comparator, sensitivity of saliva was 56.1% (47.5-64.5, CI 95%), specificity 63.5%(50.4-75.3, CI95%) with PPV of 77.2% and NPV of 39.6% and that of self-swab was 52.3%(44-60.5%, CI95%), specificity 56.6% (42.3-70.2%, CI95%) with PPV 77.2% and NPV29.7%. Comparison of positivity with the onset of symptoms revealed highest detection in saliva on day 3 after onset of symptoms. Additionally, only saliva was positive in 13 (12.8%) hospitalized patients.Conclusion: Our results demonstrate the use of saliva to detect SARS-COV-2 in symptomatic patients early after the onset of symptoms. Additionally, these results suggest that saliva may not be recommended as a screening tool at the community level due to the lower detection rate than that for swabs. Saliva testing in symptomatic patients whose nasopharyngeal swab does not detect SARS-CoV-2 reduces false negativity.

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A Large Cohort Study of SARS-CoV-2 Detection in Saliva: A Non-Invasive Alternative Diagnostic Test for Patients with Bleeding Disorders

Viruses ◽

10.3390/v13122361 ◽

2021 ◽

Vol 13 (12) ◽

pp. 2361

Author(s):

Josiane Iole França Lopes ◽

Carlos Alexandre da Costa Silva ◽

Rodrigo Guimarães Cunha ◽

Alexandra Martins Soares ◽

Maria Esther Duarte Lopes ◽

...

Keyword(s):

Healthcare Workers ◽

Hospitalized Patients ◽

Bleeding Disorders ◽

Hematological Diseases ◽

Non Invasive ◽

Qrt Pcr ◽

Large Cohort Study ◽

The Mean ◽

Sensitivity Specificity ◽

Higher Sensitivity

Diagnosis of SARS-CoV-2 infections is mostly based on the nasopharyngeal swabs (NPS). However, this collection is invasive and uncomfortable, especially for children and patients with coagulopathies, whose NPS collection often causes bleeding. Thus, the aim of this study was to evaluate the usefulness and accuracy of saliva for the diagnosis of COVID-19 in patients presenting bleeding disorders. Samples of NPS, oropharyngeal swabs (OPS), and saliva were collected simultaneously from 1159 hospitalized patients with hematological diseases and from 524 healthcare workers, both symptomatic and asymptomatic for SARS-CoV-2. All samples were evaluated for SARS-CoV-2 by qRT-PCR. SARS-CoV-2 was detected in NPS, OPS and saliva from 16.9%, 14.4% and 15.6% individuals, respectively. Tests in saliva showed sensitivity, specificity, and overall agreement of 73.3%, 96.9% and 92.7% (=0.74), respectively. Salivary tests had good accuracy (AUC = 0.7) for discriminating negative and positive qRT-PCR for SARS-CoV-2. Higher sensitivity was observed in symptomatic than in non-symptomatic patients, as well as in healthy subjects than in patients with hematological disease, in both OPS and saliva. The mean viral load in NPS was significantly higher than in OPS and in saliva samples (p < 0.001). Saliva is a good diagnostic tool to detect SARS-CoV-2, especially among patients symptomatic for COVID-19, and is a valuable specimen for mass screening of hospitalized patients with hematological diseases, especially for those that with bleeding disorders.

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COVID-19 Seroprevalence among Healthcare Workers of a Large COVID-19 Hospital in Rome Reveals Strengths and Limits of Two Different Serological Tests

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18052650 ◽

2021 ◽

Vol 18 (5) ◽

pp. 2650

Author(s):

Giuseppe Vetrugno ◽

Daniele Ignazio La Milia ◽

Floriana D’Ambrosio ◽

Marcello Di Pumpo ◽

Roberta Pastorino ◽

...

Keyword(s):

Blood Test ◽

Healthcare Workers ◽

Point Of Care ◽

Venous Blood ◽

Administrative Staff ◽

Serological Tests ◽

Predictive Values ◽

Work From Home ◽

Significant Difference ◽

Sensitivity Specificity

Healthcare workers are at the forefront against COVID-19, worldwide. Since Fondazione Policlinico Universitario A. Gemelli (FPG) IRCCS was enlisted as a COVID-19 hospital, the healthcare workers deployed to COVID-19 wards were separated from those with limited/no exposure, whereas the administrative staff were designated to work from home. Between 4 June and 3 July 2020, an investigation was conducted to evaluate the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin (IgG) antibodies among the employees of the FPG using point-of-care (POC) and venous blood tests. Sensitivity, specificity, and predictive values were determined with reverse-transcription polymerase chain reaction on nasal/oropharyngeal swabs as the diagnostic gold standard. The participants enrolled amounted to 4777. Seroprevalence was 3.66% using the POC test and 1.19% using the venous blood test, with a significant difference (p < 0.05). The POC test sensitivity and specificity were, respectively, 63.64% (95% confidence interval (CI): 62.20% to 65.04%) and 96.64% (95% CI: 96.05% to 97.13%), while those of the venous blood test were, respectively, 78.79% (95% CI: 77.58% to 79.94%) and 99.36% (95% CI: 99.07% to 99.55%). Among the low-risk populations, the POC test’s predictive values were 58.33% (positive) and 98.23% (negative), whereas those of the venous blood test were 92.86% (positive) and 98.53% (negative). According to our study, these serological tests cannot be a valid alternative to diagnose COVID-19 infection in progress.

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Hysteroscopy as a standard procedure for assessing endometrial lesions among postmenopausal women

Sao Paulo Medical Journal ◽

10.1590/s1516-31802007000600007 ◽

2007 ◽

Vol 125 (6) ◽

pp. 338-342 ◽

Cited By ~ 7

Author(s):

Camila Toffoli Ribeiro ◽

Júlio César Rosa-e-Silva ◽

Marcos Felipe Silva-de-Sá ◽

Ana Carolina Japur de Sá Rosa-e-Silva ◽

Omero Benedicto Poli Neto ◽

...

Keyword(s):

Endometrial Thickness ◽

Standard Procedure ◽

University Hospital ◽

Histopathological Analysis ◽

Benign Lesions ◽

Predictive Values ◽

Asymptomatic Patients ◽

Cavity Design ◽

Diagnostic Hysteroscopy ◽

Sensitivity Specificity

CONTEXT AND OBJECTIVES: Endometrial cancer is the most prevalent type of malignant neoplasia of the genital tract. The objective of this study was to calculate the sensitivity, specificity, accuracy and positive and negative predictive values for diagnostic hysteroscopy, in comparison with histopathological tests, for all lesions of the endometrial cavity. DESIGN AND SETTING: Retrospective descriptive study at the public tertiary-level university hospital of Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo. METHODS: Diagnostic hysteroscopy was indicated in the following instances: endometrial thickness > 4 mm in asymptomatic patients; postmenopausal bleeding; and irregular endometrium or endometrium difficult to assess from ultrasound, with or without vaginal bleeding. Ultrasound evaluations were carried out no more than three months prior to hysteroscopy. RESULTS: There were 510 patients, with a mean age of 61.1 ± 2.0 years and mean time elapsed since the menopause of 12.7 ± 2.5 years. Endometrial biopsies were performed on 293 patients (57.5%). Histopathological analysis showed that 18 patients presented endometrial carcinoma or typical or atypical hyperplasia, and none of them presented endometrial thickness of less than 8 mm. No significant differences were found between the median thicknesses of the various benign lesions (p > 0.05). In our data, the sensitivity, specificity, accuracy and positive and negative predictive values for cancer or hyperplasia were 94.4%, 97.0%, 96.8%, 68% and 99.6%, respectively. CONCLUSIONS: Our results suggest that hysteroscopy is valuable as a diagnostic tool for malignant/hyperplastic and benign lesions, except for submucous myomas, for which the sensitivity was only 52.6%.

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Urea-Fibrinogen Slide Coagulase Test – A Simple Alternative Method for the Rapid Identification of Staphylococcus aureus

Journal of Gandaki Medical College-Nepal ◽

10.3126/jgmcn.v10i1.17903 ◽

2017 ◽

Vol 10 (1) ◽

pp. 5-10

Author(s):

Binita Koirala Sharma ◽

S Gokhale ◽

K Sharma

Keyword(s):

Staphylococcus Aureus ◽

Sensitivity And Specificity ◽

Reference Method ◽

Cost Effective ◽

Rapid Identification ◽

Accurate Identification ◽

Predictive Values ◽

Negative Results ◽

Animal Pathogens ◽

Sensitivity Specificity

Introduction: The accurate identification of Staphylococcus aureus clinical isolates requires a series of tests. Morphological features and slide coagulase test are two criteria on which S. aureus are identified. Resort to tube coagulase test is sought when results of slide coagulase test are equivocal or doubtful. Both coagulase tests detect the enzymes that convert fibrinogen into fibrin. Human, rabbit or sheep pooled plasma is used as substrate for both tests. Slide coagulase test is simpler and faster as compared to tube coagulase test. The plasma could be carrier of many human and animal pathogens like HIV, HBV, HCV etc. Storage of plasma for longer duration is fraught with chances of contamination. Improperly stored plasma can lead to false positive or negative results. Citrated plasma may be unsuitable for this test if contaminated with citrate utilizing bacteria. Considering the role of S. aureus as a common etiological agent in nosocomial and community infections, there is a need of implementing rapid, easy and cost-effective phenotypic test.Objectives: Considering the disadvantages and risks associated with fresh plasma, this study aims to launch for safer, more reliable substitute with longer shelf life that may provide reliable results for prompt identification of S. aureus by slide coagulase test.Methods: The present work evaluates slide coagulase test (SCT), and urea fibrinogen slide coagulase test (UF-SCT) for S. aureus detection considering Tube coagulase test (TCT) as the reference method. Sensitivity, specificity, positive predictive value and negative predictive values of SCT and UF-SCT were calculated using TCT as gold standard. Results: A total of 150 staphylococcal isolates from different clinical specimens ere selected for the evaluation of coagulase tests. All the specimens were subjected to SCT, UF-SCT and TCT. The UF-SCT showed better sensitivity (95.04%), specificity (100%), PPV (100%), and NPV (82.85%) with reference to TCT. UF-SCT showed similar sensitivity and specificity to SCT. None of the isolates were negative in UF-SCT and positive in SCT. Since UF-SCT does not incorporate plasma directly and at the same time has a very good sensitivity and specificity, it is recommended that UF-SCT could replace SCT for identification of S. aureus.Conclusion: The findings of present study shall encourage laboratories to use the urea-fibrinogen slide coagulase test routinely for the rapid identification of S aureus.Journal of Gandaki Medical College Vol. 10, No. 1, 2017, Page: 5-10

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Epidemiology and molecular diagnosis of canine coronavirus in Egypt: evaluation of different tests used for its diagnosis

BULGARIAN JOURNAL OF VETERINARY MEDICINE ◽

10.15547/bjvm.2019-0024 ◽

2020 ◽

Vol 23 (4) ◽

pp. 467-477

Author(s):

R. Awad ◽

S. Ali Hassan ◽

A. Attallah ◽

W. Khalil

Keyword(s):

Clinical Signs ◽

Conventional Polymerase Chain Reaction ◽

Pcr Analysis ◽

Conventional Pcr ◽

Predictive Values ◽

S Protein ◽

Qrt Pcr ◽

Canine Coronavirus ◽

Pcr Products ◽

Sensitivity Specificity

This work aimed to study the epidemiology and molecular detection of existing canine coronavirus (CCoV) strain circulating in Egypt. A total number of 86 dogs with clinical signs suggestive for CCoV infection was subjected to clinical examination and quick immunochromatography (IC) on faecal swabs to detect viral antigen. To identify CCoV viral RNA and S protein gene in blood and faeces, conventional PCR and quantitative RT-PCR were used. All examined dogs showed clinical signs suggestive of CCoV infection. Only 32 out of 86 dogs were positive for IC. Of all samples, 36 showed positive results in PCR and the amplification products from these 36 samples were confirmed as CCoV-S protein partial gene by the analysis of nucleotide sequence. However, the qRT-PCR analysis detected 45 positive samples e.g. more than those of IC or conventional polymerase chain reaction. Statistical evaluation of IC and conventional PCR to the results of qRT-PCR performance showed sensitivity, specificity, accuracy, positive and negative predictive values of 71%, 100%, 84.9%, 100%, 75.9% for IC and 80%, 100%, 89.5%, 100%, 82% for PCR, respectively. Sex and age had no effects on IC and PCR results. The prevalence of CCoV infection among the population of this study was 52.3%. Sequence analysis results proved that CCoV strain 59/08 was the strain, circulating in Egypt among dog populations. PCR products of the CCoV cDNA were closely identical to published CCoV-S partial gene. The NCBI Genbank accession number of sequence of the studied gene (CCoV-S partial gene) in this study was KY655745.

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Diagnostic yield of transbronchial needle aspiration for lymphoma

South African Respiratory Journal ◽

10.7196/sarj.2016.v22i3.80 ◽

2016 ◽

Vol 22 (3) ◽

pp. 67

Author(s):

B Sonnekus ◽

J Steenkamp ◽

M Louw ◽

C F N Koegelenberg

Keyword(s):

Predictive Value ◽

Diagnostic Yield ◽

Cost Effective ◽

Final Diagnosis ◽

Needle Aspiration ◽

Tracheobronchial Tree ◽

Transbronchial Needle Aspiration ◽

Predictive Values ◽

Hilar Adenopathy ◽

Sensitivity Specificity

Background. Transbronchial needle aspiration (TBNA) is a minimally invasive bronchoscopic technique that is cost-effective and safe for diagnosing mediastinal and hilar adenopathy in lung cancer, other malignancies, sarcoidosis and infectious processes such as tuberculosis. Few studies have analysed the sensitivity, specificity and predictive values of TBNA for diagnosing lymphoma.Objective. To evaluate the diagnostic yield of TBNA for diagnosing mediastinal and hilar adenopathy in suspected lymphoma.Methods. We performed a retrospective analysis of collected data of patients with mediastinal and hilar adenopathy adjacent to the tracheobronchial tree detected by thoracic computed tomography, who underwent TBNA at Tygerberg Hospital between July 2010 and June 2013. We included 25 patients with suspected or proven lymphoma. Histology was used as the gold standard.Results. Adequate samples for cytological evaluation were obtained for 22 (88%) patients. Cytological diagnosis was possible for 8 (32%). For 17 (68%) who could not be diagnosed by TBNA alone, histology provided final diagnosis. Rapid on-site examination (ROSE) was performed in 23 (92%). In 17/23 (74%) cases, these had similar results to formal cytology. Only 4 (16%) had flow cytometry requested. Twelve (48%) had lymphoma confirmed on histology. TBNA cytology had 100% specificity and positive predictive value for suspicion of lymphoma. Sensitivity was 33% and negative predictive value 62%.Conclusion. TBNA is an appropriate first-line diagnostic procedure in evaluating mediastinal and hilar lymphadenopathy in suspected lymphoma. Biopsy should be the immediate second-line procedure when ROSE/cytology is suspicious of lymphoma or shows atypical cells. Patients with negative TBNA cytology, but high clinical or radiological suspicion of lymphoma, should be further investigated.

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Haematological Parameters in Early Diagnosis of Clinically Suspected Neonatal Septicemia

Myanmar Health Sciences Research Journal ◽

10.34299/mhsrj.00924 ◽

2019 ◽

Vol 31 (1) ◽

pp. 65-71

Keyword(s):

Early Diagnosis ◽

Late Onset ◽

Cost Effective ◽

Haematological Parameters ◽

Predictive Values ◽

Neonatal Septicemia ◽

Mature Neutrophil ◽

Life Threatening ◽

Low Sensitivity ◽

Sensitivity Specificity

Neonatal septicemia is a life-threatening yet treatable condition. It is one of the major health problems throughout the world. Blood culture is the gold standard for diagnosis of neonatal septicemia and should be performed in all cases of suspected septicemia prior to starting antibiotics. But in the present study, the use of the haematological parameters was evaluated to determine the early diagnosis of neonatal septicemia. It was carried out in the neonatal unit of Mandalay Children’s Hospital from September 2012 to August 2013. Out of 68 cases of clinically suspected neonatal septicemia, bacterial pathogens were isolated from 33 cases. Early onset neonatal septicemia was more common than late onset. Among 33 cases of culture-proven neonatal septicemia, septicemia is not likely in 1 case (3%) while borderline for septicemia and septicemia in 6 cases (18.2%) is very likely in 26 cases (78.8%) according to haematological scoring system (HSS). HSS assigns a score of one for each of seven haematological parameters. Out of the seven haematological parameters, immature to total neutrophil ratio (I:T) and immature to mature neutrophil ratio (I:M) were the most reliable test for the neonatal septicemia. Thrombocytopenia had low sensitivity. The haematolgical parameters are simple, quick, cost effective and readily available. The sensitivity, specificity and the predictive values of haematological parameters could be enhanced by combination of these parameters rather than the use of single parameter.

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Validation of plasma miR-371a-3p expression in patients with metastatic and early stage germ cell tumor.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.7_suppl.526 ◽

2019 ◽

Vol 37 (7_suppl) ◽

pp. 526-526 ◽

Cited By ~ 1

Author(s):

Lucia Nappi ◽

Marisa Thi ◽

Amy Lum ◽

David Huntsman ◽

Bernhard J. Eigl ◽

...

Keyword(s):

Germ Cell ◽

Validation Cohort ◽

Early Stage ◽

Clinical Stage ◽

Diagnostic Tools ◽

Rt Pcr ◽

Predictive Values ◽

Sensitivity Specificity ◽

Cell Malignancy

526 Background: Identification of relapsing/residual viable germ cell malignancy (GCM) is often challenging in patients with CSI on surveillance or with residual post-chemotherapy disease. The presence of a biomarker for GCM would overcome the uncertainty of the current methods and improve the quality of care of those patients. Methods: A 2-cohorts pilot study involving patients with clearcut evidence of GCM (clinical stage IS, metastatic and GCM prior orchiectomy) for the development cohort and patients with CSI with or without signs of tumor relapse and patients with metastatic GCM post-chemotherapy for the validation cohort. Blood samples collected in Streck tubes were obtained prior to chemotherapy for the development cohort and post-orchiectomy, at the time of suspicious relapse or post-chemotherapy in the validation cohort. Plasma miR-371a-3p (miR371) was analyzed by RT-PCR. Positive predictive value (PPV), sensitivity, specificity, negative predictive values (NPV) and AUC of the ROC for miR371 and standard diagnostic tools (CT scan, AFP, BHCG and LDH) were calculated correlating qualitative miR371 expression to the presence of viable GCM. Results: 132 patients were enrolled into the development (33 pts) and validation (99 pts) cohorts. Within the development cohort 31/33 pts were miR371 positive, 2/33 pts were negative. 31 true positives were found among the 31 miR371 positive patients for a PPV of 100% (31/31). Two true negatives were found among the 2 patients who had no miR371 expression identified (teratoma, lymphoma). The validation cohort was chosen to evaluate the methodology among patients with predicted lower volumes or no clinically apparent disease. 13/99 patients within the validation cohort were miR371 positive and all 13 had subsequent confirmation of viable GCM. For the overall study of 132 pts, PPV was 100% (46/46), NPV 98%, sensitivity 96% and specificity 100%, the AUC of the ROC was 0.96. Conclusions: Detectable circulating miR-371a-3p levels predict viable GCM and may represent a strategy for biological rather than radiographic assessment for surveillance of early stage and for post-treatment patients. Larger studies to validate these and like results have been planned.

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Validation of the Red Flags Index for Early Diagnosis of Crohn’s Disease: A Prospective Observational IG-IBD Study Among General Practitioners

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjaa111 ◽

2020 ◽

Vol 14 (12) ◽

pp. 1777-1779

Author(s):

Gionata Fiorino ◽

Stefanos Bonovas ◽

Daniela Gilardi ◽

Antonio Di Sabatino ◽

Mariangela Allocca ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

General Practitioners ◽

Early Stage ◽

Diagnostic Delay ◽

Diagnostic Strategy ◽

Red Flags ◽

Faecal Calprotectin ◽

Predictive Values ◽

Sensitivity Specificity

Abstract Introduction Diagnostic delay >12 months is frequent in Crohn’s disease [CD]. Recently, the International Organization for Inflammatory Bowel Disease [IO-IBD] developed a tool to identify early CD and reduce diagnostic delay. Subjects with an index ≥8 are more likely to have suspected CD (odds ratio [OR] 205, p <0.0001). We aimed to validate this questionnaire at the community level in patients seen by the general practitioners [GPs] in two large areas of Lombardy, Italy. Methods Consecutive adult patients referring to the GP were screened. The GPs administered the Red Flags [RF] questionnaire to the eligible patients. All patients were referred to the nearest participating centre to confirm or exclude the diagnosis of CD. Sensitivity, specificity, and positive and negative predictive values [PPV, NPV] of the RF index [RFI] were calculated. Patients lost to follow-up after the first gastroenterological visit were analysed using a non-responder imputation, assuming they were negative for CD diagnosis. Results From November 2016 to November 2019, 112 patients were included. A total of 66 subjects [59%] completed the study after the first gastroenterological visit. The prevalence of CD was 3.6% in the study population [4/112]. The RF index had 50% sensitivity, 58% specificity, 4% PPV, and 97% NPV. A combined diagnostic strategy with faecal calprotectin [FC] [RFI ≥8 and/or FC >250 ng/g] resulted in significantly improved accuracy: sensitivity 100% [29–100%], specificity 72% [55–85%], PPV = 21% [5–51%], NPV = 100% [88–100%]. Conclusions The RF Index combined with FC is a valid tool to identify patients with high probability of having CD at early stage.

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