Pub Date : 2020-12-01DOI: 10.1097/POC.0000000000000215
Nicholas N. Faber, Shanaya C. Bulmer, Mona A. Gandhi, Angela K. Nagel
Purpose The aim of this review was to summarize new data on the use of international normalized ratio (INR) point-of-care testing (POCT) devices in hypercoagulable disease states such as antiphospholipid syndrome (APS) and those with left ventricular assist devices (LVADs). Methods PubMed and Google Scholar were searched for keywords relating to warfarin, point-of-care testing, and hypercoagulable conditions. Intensive care unit studies and articles not in English were excluded. Results Four recent studies examining 3 different POCT devices in patients with APS and 2 for patients with LVADs were found. The studies compared devices against laboratory INRs as a standard or against another POCT device to determine device agreeability or bias. Results showed that CoaguChek XS does not correlate well with laboratory INRs in patients with APS but is acceptable in LVAD patients. Coagsense and ProTime InRhythm correlated well with laboratory INR values in APS patients. Conclusions Coagsense and ProTime InRhythm may be acceptable POCT devices to use for APS patients, whereas CoaguChek XS is not acceptable. In LVAD patients, CoaguChek XS is acceptable because it correlates well with laboratory INR values.
{"title":"Point-of-Care Testing in Hypercoagulable Conditions Managed With Warfarin","authors":"Nicholas N. Faber, Shanaya C. Bulmer, Mona A. Gandhi, Angela K. Nagel","doi":"10.1097/POC.0000000000000215","DOIUrl":"https://doi.org/10.1097/POC.0000000000000215","url":null,"abstract":"Purpose The aim of this review was to summarize new data on the use of international normalized ratio (INR) point-of-care testing (POCT) devices in hypercoagulable disease states such as antiphospholipid syndrome (APS) and those with left ventricular assist devices (LVADs). Methods PubMed and Google Scholar were searched for keywords relating to warfarin, point-of-care testing, and hypercoagulable conditions. Intensive care unit studies and articles not in English were excluded. Results Four recent studies examining 3 different POCT devices in patients with APS and 2 for patients with LVADs were found. The studies compared devices against laboratory INRs as a standard or against another POCT device to determine device agreeability or bias. Results showed that CoaguChek XS does not correlate well with laboratory INRs in patients with APS but is acceptable in LVAD patients. Coagsense and ProTime InRhythm correlated well with laboratory INR values in APS patients. Conclusions Coagsense and ProTime InRhythm may be acceptable POCT devices to use for APS patients, whereas CoaguChek XS is not acceptable. In LVAD patients, CoaguChek XS is acceptable because it correlates well with laboratory INR values.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"48 1","pages":"101 - 105"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76901204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-12-01DOI: 10.1097/poc.0000000000000216
B. Toben, Michael Martin
{"title":"Rapid Assessment of Coagulation at the Point of Care With the Hemochron Signature Elite System","authors":"B. Toben, Michael Martin","doi":"10.1097/poc.0000000000000216","DOIUrl":"https://doi.org/10.1097/poc.0000000000000216","url":null,"abstract":"","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"16 1","pages":"116-121"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90235787","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-12-01DOI: 10.1097/POC.0000000000000213
Ayman H. K. Alserr, R. Menshawey, A. Kotb, Nourhan Hussein, Noha Kotp, Mahmoud Ashraf-Taha, Nouran Anwar, Asma M Abdalla, Menna Abdullah, Shaimaa Abol Ela, H. Khairy
Purpose This prospective comparative study aims to evaluate the accuracy and validity of CoaguChek XS point-of-care system (Roche Diagnostics GmbH, Mannheim, Germany), compared with the standard central laboratory international normalized ratio (INR) results, in a vascular surgery ward. Methods Data based on 54 INR pairs, measured by the central laboratory analyzer and CoaguChek XS, were compared using the intraclass correlation coefficient. Other outcomes included the time and cost of the service from the patient's perspectives. Correlation was assessed using Pearson correlation test. Bland-Altman analysis was done to determine mean difference and 95% limits of agreement. Cohen κ test was done to assess agreement between the 2 methods. Results The mean INR values for CoaguChek XS and standard laboratory (Sysmex Ca-1500 system; Siemens Healthcare Diagnostics, Erlangen, Germany) were 1.21 ± 0.28 and 1.24 ± 0.43, respectively. The Pearson correlation coefficient in all 108 measurements was (r) = 0.591 (95% confidence interval, 0.38–0.74; P < 0.0001), indicating a moderately positive correlation. Overall intraclass correlation coefficient was 0.803 (95% confidence interval, 0.324–0.707) indicating good reliability. Bland-Altman analysis showed a bias of 0.035 and a 95% limits of agreement ranging from −0.63 to 0.70. There was substantial agreement between the 2 methods (κ = 0.694; SE, 0.108; 95% confidence interval, 0.481–0.907). CoaguChek XS results were obtained, on average, 213 minutes faster than the standard laboratory. Conclusions CoaguChek XS appears to have positive correlation, substantial agreement, and good reliability when compared with the standard laboratory. Thus, it is recommended to be used in hospital settings.
{"title":"A Comparison of International Normalized Ratio Results by Point-of-Care Device and Clinical Laboratory Analyzers in a Vascular Surgery Department","authors":"Ayman H. K. Alserr, R. Menshawey, A. Kotb, Nourhan Hussein, Noha Kotp, Mahmoud Ashraf-Taha, Nouran Anwar, Asma M Abdalla, Menna Abdullah, Shaimaa Abol Ela, H. Khairy","doi":"10.1097/POC.0000000000000213","DOIUrl":"https://doi.org/10.1097/POC.0000000000000213","url":null,"abstract":"Purpose This prospective comparative study aims to evaluate the accuracy and validity of CoaguChek XS point-of-care system (Roche Diagnostics GmbH, Mannheim, Germany), compared with the standard central laboratory international normalized ratio (INR) results, in a vascular surgery ward. Methods Data based on 54 INR pairs, measured by the central laboratory analyzer and CoaguChek XS, were compared using the intraclass correlation coefficient. Other outcomes included the time and cost of the service from the patient's perspectives. Correlation was assessed using Pearson correlation test. Bland-Altman analysis was done to determine mean difference and 95% limits of agreement. Cohen κ test was done to assess agreement between the 2 methods. Results The mean INR values for CoaguChek XS and standard laboratory (Sysmex Ca-1500 system; Siemens Healthcare Diagnostics, Erlangen, Germany) were 1.21 ± 0.28 and 1.24 ± 0.43, respectively. The Pearson correlation coefficient in all 108 measurements was (r) = 0.591 (95% confidence interval, 0.38–0.74; P < 0.0001), indicating a moderately positive correlation. Overall intraclass correlation coefficient was 0.803 (95% confidence interval, 0.324–0.707) indicating good reliability. Bland-Altman analysis showed a bias of 0.035 and a 95% limits of agreement ranging from −0.63 to 0.70. There was substantial agreement between the 2 methods (κ = 0.694; SE, 0.108; 95% confidence interval, 0.481–0.907). CoaguChek XS results were obtained, on average, 213 minutes faster than the standard laboratory. Conclusions CoaguChek XS appears to have positive correlation, substantial agreement, and good reliability when compared with the standard laboratory. Thus, it is recommended to be used in hospital settings.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"85 1","pages":"106 - 111"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76248348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-12-01DOI: 10.1097/POC.0000000000000212
S. Bench
Abstract The main users of point-of-care testing devices placed outside the central laboratory are clinicians, predominantly nurses. Understanding the factors influencing sample accuracy is important to ensure appropriate clinical decision making. Previous studies focus on the analysis process; however, errors can also occur during the preanalytical phase, linked to user knowledge, skills, and other factors associated with the wider context of care. This study explored adult critical care nurses' views about point-of-care testing, the challenges they experience, and their suggestions on how the preanalytical phase might be improved. Using a qualitative design, 4 focus group discussions took place with 60 critical care nurses studying at 2 London-based universities between April and July 2019. Anonymized and verbatim-transcribed focus group data were uploaded into NVivo11 and underwent a standard process of inductive thematic analysis. Findings suggest that nurses' concerns focus on 3 key areas: training and competence; sample frequency and volume; and impacts on patients, relatives, and staff. Critical care nurses view point-of-care testing as a necessary task, which aids timely patient management. However, the process can detract nurses from performing other care duties. Being able to draw less blood was identified as an important way to increase patient comfort and to reduce risks. Collaborative working is key to ensure that improvements made to the preanalytical process reflect users' needs. Ensuring best use of nurses' time by streamlining preanalytical processes and ensuring equipment is readily available for use are important to ensure other clinical priorities can be achieved.
{"title":"Critical Care Nurses' Views and Experiences of Preanalytical Factors Influencing Point-of-Care Testing","authors":"S. Bench","doi":"10.1097/POC.0000000000000212","DOIUrl":"https://doi.org/10.1097/POC.0000000000000212","url":null,"abstract":"Abstract The main users of point-of-care testing devices placed outside the central laboratory are clinicians, predominantly nurses. Understanding the factors influencing sample accuracy is important to ensure appropriate clinical decision making. Previous studies focus on the analysis process; however, errors can also occur during the preanalytical phase, linked to user knowledge, skills, and other factors associated with the wider context of care. This study explored adult critical care nurses' views about point-of-care testing, the challenges they experience, and their suggestions on how the preanalytical phase might be improved. Using a qualitative design, 4 focus group discussions took place with 60 critical care nurses studying at 2 London-based universities between April and July 2019. Anonymized and verbatim-transcribed focus group data were uploaded into NVivo11 and underwent a standard process of inductive thematic analysis. Findings suggest that nurses' concerns focus on 3 key areas: training and competence; sample frequency and volume; and impacts on patients, relatives, and staff. Critical care nurses view point-of-care testing as a necessary task, which aids timely patient management. However, the process can detract nurses from performing other care duties. Being able to draw less blood was identified as an important way to increase patient comfort and to reduce risks. Collaborative working is key to ensure that improvements made to the preanalytical process reflect users' needs. Ensuring best use of nurses' time by streamlining preanalytical processes and ensuring equipment is readily available for use are important to ensure other clinical priorities can be achieved.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"35 1","pages":"97 - 100"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89518007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-09-01DOI: 10.1097/POC.0000000000000211
M. Winters
L yme disease is caused by an infection with the bacterium Borrelia burgdorferi. The bacteria is carried by the ticks and is transferred via the tick's bite. Lyme disease is estimated to be the most commonvector-borne illness in the United States. Diagnosis of the disease is challenging because of symptoms that can mimic other diseases. People treated with appropriate antibiotics in the early stages of Lyme disease usually recover rapidly and completely. Therefore, it is important to diagnose the illness early and accurately. Commercially available Lyme assays are designed to detect antibodies (either IgM, IgG, or IgM/IgG combined) in the patient's blood. The most commonly used assays require serum, which required processing of the patient's blood before testing. This processing step often requires the specimen to be sent to larger hospital and reference laboratories for testing. This lack of “near-patient” testing delays patient diagnosis and potential treatment. The Sofia 2 Lyme Fluorescent Immunoassay (FIA) eliminates the specimen processing requirement is the first and only test that can detect the antibodies to the B. burgdorferi bacteria with only a fingerstick. Because of its ease of use and diagnostic performance, the Sofia 2 test has been granted a Clinical Laboratory Improvement Amendments (CLIA) Waiver. This makes the test available in Physician's Offices and Urgent Care facilities for “near-patient” testing. With the new availability of a rapid and accurate result, providers can determine the next steps for treatment without delay.
{"title":"Invited Product Profile: Detecting Antibodies for Lyme Disease at the Point of Care","authors":"M. Winters","doi":"10.1097/POC.0000000000000211","DOIUrl":"https://doi.org/10.1097/POC.0000000000000211","url":null,"abstract":"L yme disease is caused by an infection with the bacterium Borrelia burgdorferi. The bacteria is carried by the ticks and is transferred via the tick's bite. Lyme disease is estimated to be the most commonvector-borne illness in the United States. Diagnosis of the disease is challenging because of symptoms that can mimic other diseases. People treated with appropriate antibiotics in the early stages of Lyme disease usually recover rapidly and completely. Therefore, it is important to diagnose the illness early and accurately. Commercially available Lyme assays are designed to detect antibodies (either IgM, IgG, or IgM/IgG combined) in the patient's blood. The most commonly used assays require serum, which required processing of the patient's blood before testing. This processing step often requires the specimen to be sent to larger hospital and reference laboratories for testing. This lack of “near-patient” testing delays patient diagnosis and potential treatment. The Sofia 2 Lyme Fluorescent Immunoassay (FIA) eliminates the specimen processing requirement is the first and only test that can detect the antibodies to the B. burgdorferi bacteria with only a fingerstick. Because of its ease of use and diagnostic performance, the Sofia 2 test has been granted a Clinical Laboratory Improvement Amendments (CLIA) Waiver. This makes the test available in Physician's Offices and Urgent Care facilities for “near-patient” testing. With the new availability of a rapid and accurate result, providers can determine the next steps for treatment without delay.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"55 8","pages":"95 - 96"},"PeriodicalIF":0.0,"publicationDate":"2020-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72554342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-09-01DOI: 10.1097/POC.0000000000000210
C. Jaja, J. Edem-Hotah, J. Shepherd, N. Patel, Hongyan Xu, R. Gibson
Abstract Microtechnology point-of-care tests (POCTs), which are accurate and easy to use, are needed for the diagnosis of infants with sickle cell disease (SCD) to facilitate linkage to early care and management in resource-constrained public health centers in sub-Saharan Africa. We systematically reviewed the evidence of 2 novel POCTs' characteristics, performance, and clinical utility compared with standard laboratory-based methods. Studies evaluating the use of POCTs for SCD screening were identified by a search of PubMed and CINAHL. Eighty-four abstracts were screened, and 68 full-text articles were assessed, of which 12 met the inclusion criteria. Twelve studies conducted in 10 countries evaluated performance and diagnostic accuracy of 2 qualitative immunoassay POCTs (Sickle SCAN and HemoTypeSC). Eight studies were field reviews that compared the performance of the POCTs to extant laboratory methods, and one study reported on clinical management of SCD. The studies of diagnostic accuracy showed excellent performance for immunoassay POCTs. The reported correlation between criterion standard comparator laboratory-based assays was high across the 2 POCTs. Specificity for both POCTs was excellent among newborns and infants even in the presence of high fetal hemoglobin levels. The POCTs were deemed easy to use and had rapid turnaround times. The performance of immunoassay SCD-POCTs is comparable to reference assays, and the SCD-POCTs have the potential to improve patient outcomes. Additional studies on clinical utility, implementation, and accessibility are needed. Future research should focus on understanding and mapping the barriers to implementation within the context of resource-constrained settings.
{"title":"Analytic Characteristics and Performance of Novel Immunoassay Point-of-Care Tests for Early Diagnosis of Sickle Cell Disease","authors":"C. Jaja, J. Edem-Hotah, J. Shepherd, N. Patel, Hongyan Xu, R. Gibson","doi":"10.1097/POC.0000000000000210","DOIUrl":"https://doi.org/10.1097/POC.0000000000000210","url":null,"abstract":"Abstract Microtechnology point-of-care tests (POCTs), which are accurate and easy to use, are needed for the diagnosis of infants with sickle cell disease (SCD) to facilitate linkage to early care and management in resource-constrained public health centers in sub-Saharan Africa. We systematically reviewed the evidence of 2 novel POCTs' characteristics, performance, and clinical utility compared with standard laboratory-based methods. Studies evaluating the use of POCTs for SCD screening were identified by a search of PubMed and CINAHL. Eighty-four abstracts were screened, and 68 full-text articles were assessed, of which 12 met the inclusion criteria. Twelve studies conducted in 10 countries evaluated performance and diagnostic accuracy of 2 qualitative immunoassay POCTs (Sickle SCAN and HemoTypeSC). Eight studies were field reviews that compared the performance of the POCTs to extant laboratory methods, and one study reported on clinical management of SCD. The studies of diagnostic accuracy showed excellent performance for immunoassay POCTs. The reported correlation between criterion standard comparator laboratory-based assays was high across the 2 POCTs. Specificity for both POCTs was excellent among newborns and infants even in the presence of high fetal hemoglobin levels. The POCTs were deemed easy to use and had rapid turnaround times. The performance of immunoassay SCD-POCTs is comparable to reference assays, and the SCD-POCTs have the potential to improve patient outcomes. Additional studies on clinical utility, implementation, and accessibility are needed. Future research should focus on understanding and mapping the barriers to implementation within the context of resource-constrained settings.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"94 8 1","pages":"84 - 94"},"PeriodicalIF":0.0,"publicationDate":"2020-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79654461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-09-01DOI: 10.1097/POC.0000000000000207
H. Völler, K. Heyne
Background The LumiraDx INR Test is a new point-of-care diagnostic test designed to analyze fingerstick blood samples. The test was assessed in patients receiving phenprocoumon (NCT04074980). Methods Venous plasma international normalized ratio (INR) was measured using the LumiraDx INR Test. LumiraDx INR Test-ascertained capillary whole blood INR was compared with venous plasma INR measured using the IL ACL Elite Pro and Sysmex CS-5100 reference instruments. Results A total of 102 patients receiving phenprocoumon were recruited. The INR results from venous plasma and capillary whole blood that were analyzed on the LumiraDx INR Test correlated well with those measured using the IL ACL Elite Pro (plasma: n = 25, r = 0.981; capillary blood: n = 74, r = 0.949) and the Sysmex CS-5100 (n = 73, r = 0.950). Conclusions The LumiraDx INR Test showed high accuracy in analyzing venous plasma and capillary whole blood from patients receiving phenprocoumon.
{"title":"Evaluation of the Accuracy of the LumiraDx INR Test Using Patients in Receipt of Phenprocoumon Anticoagulation Therapy","authors":"H. Völler, K. Heyne","doi":"10.1097/POC.0000000000000207","DOIUrl":"https://doi.org/10.1097/POC.0000000000000207","url":null,"abstract":"Background The LumiraDx INR Test is a new point-of-care diagnostic test designed to analyze fingerstick blood samples. The test was assessed in patients receiving phenprocoumon (NCT04074980). Methods Venous plasma international normalized ratio (INR) was measured using the LumiraDx INR Test. LumiraDx INR Test-ascertained capillary whole blood INR was compared with venous plasma INR measured using the IL ACL Elite Pro and Sysmex CS-5100 reference instruments. Results A total of 102 patients receiving phenprocoumon were recruited. The INR results from venous plasma and capillary whole blood that were analyzed on the LumiraDx INR Test correlated well with those measured using the IL ACL Elite Pro (plasma: n = 25, r = 0.981; capillary blood: n = 74, r = 0.949) and the Sysmex CS-5100 (n = 73, r = 0.950). Conclusions The LumiraDx INR Test showed high accuracy in analyzing venous plasma and capillary whole blood from patients receiving phenprocoumon.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"179 1","pages":"72 - 76"},"PeriodicalIF":0.0,"publicationDate":"2020-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77777793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-09-01DOI: 10.1097/POC.0000000000000208
A. Ramezani, Roya Darbani, Lars Eng, J. Lönn, Lan Yin, F. Nayeri, A. Theodorsson
Supplemental digital content is available in the text. Background When postneurosurgery patients develop fever, there are no convenient methods to immediately indicate the site of infection. The choice of empirical antibiotic therapy is evidently different in nosocomial meningitis compared with ventilator-associated pneumonia or urinary tract infection. Conventional bacterial cultures run a risk of being false negative due to antibiotic prophylaxis, and direct microscopic analysis of cerebrospinal fluid (CSF) from such patients has limited diagnostic value. Because of the substantial mortality associated with nosocomial meningitis, broad spectrum antibiotics in high dosage are, therefore, commonly administered. Neutrophils as a part of the innate immunity system, trap and kill bacteria by neutrophil extracellular traps (NETs). Neutrophil extracellular traps are composed of extracellular DNA which is released to the CSF during bacterial meningitis. Using a combination of sulphated-glucosaminoglycan and aniline dyes, a measurement method was developed that reacts to extracellular host DNA and changes color within 1 minute in proportion to the amount of NETs in the body fluid tested. The present study aimed to evaluate the sensitivity and specificity of the “rapid NETs test” in identifying the site of infection. Methods We performed analysis on the left-over CSF samples (n = 199) that were collected routinely at neurosurgical intensive care unit. No samples were included after patients were transferred to the ward. Besides CSF, bronchoalveolar fluid, and urine samples were collected in febrile patients. The “rapid NETs test” was used for simultaneous analysis of the fresh left-over samples. The final diagnosis was settled at discharge. Results A total of 75 (64%) patients had received empirical antibiotic therapy against nosocomial meningitis, whereas only 19 patients of these cases (16%) had a verified diagnosis. The rapid NETs test could distinguish a verified meningitis (n = 19) with 89.5% sensitivity and 92.5% specificity. The test also identified ventilator-associated pneumonia (n = 32) with 93.8% sensitivity and 86.8% specificity. However, the test was not reliable in identifying nosocomial urinary tract infection (sensitivity and specificity, 78.6% and 55.2%, respectively). Conclusions The rapid NETs test indicated the site of infection in febrile patients postneurosurgery with clinically relevant sensitivity and specificity, which might show its potential to minimize the unnecessary use of antibiotics.
{"title":"A Pilot Evaluation of a Rapid Screening Test for Nosocomial Infection at a Neurosurgical Intensive Care Unit in Sweden","authors":"A. Ramezani, Roya Darbani, Lars Eng, J. Lönn, Lan Yin, F. Nayeri, A. Theodorsson","doi":"10.1097/POC.0000000000000208","DOIUrl":"https://doi.org/10.1097/POC.0000000000000208","url":null,"abstract":"Supplemental digital content is available in the text. Background When postneurosurgery patients develop fever, there are no convenient methods to immediately indicate the site of infection. The choice of empirical antibiotic therapy is evidently different in nosocomial meningitis compared with ventilator-associated pneumonia or urinary tract infection. Conventional bacterial cultures run a risk of being false negative due to antibiotic prophylaxis, and direct microscopic analysis of cerebrospinal fluid (CSF) from such patients has limited diagnostic value. Because of the substantial mortality associated with nosocomial meningitis, broad spectrum antibiotics in high dosage are, therefore, commonly administered. Neutrophils as a part of the innate immunity system, trap and kill bacteria by neutrophil extracellular traps (NETs). Neutrophil extracellular traps are composed of extracellular DNA which is released to the CSF during bacterial meningitis. Using a combination of sulphated-glucosaminoglycan and aniline dyes, a measurement method was developed that reacts to extracellular host DNA and changes color within 1 minute in proportion to the amount of NETs in the body fluid tested. The present study aimed to evaluate the sensitivity and specificity of the “rapid NETs test” in identifying the site of infection. Methods We performed analysis on the left-over CSF samples (n = 199) that were collected routinely at neurosurgical intensive care unit. No samples were included after patients were transferred to the ward. Besides CSF, bronchoalveolar fluid, and urine samples were collected in febrile patients. The “rapid NETs test” was used for simultaneous analysis of the fresh left-over samples. The final diagnosis was settled at discharge. Results A total of 75 (64%) patients had received empirical antibiotic therapy against nosocomial meningitis, whereas only 19 patients of these cases (16%) had a verified diagnosis. The rapid NETs test could distinguish a verified meningitis (n = 19) with 89.5% sensitivity and 92.5% specificity. The test also identified ventilator-associated pneumonia (n = 32) with 93.8% sensitivity and 86.8% specificity. However, the test was not reliable in identifying nosocomial urinary tract infection (sensitivity and specificity, 78.6% and 55.2%, respectively). Conclusions The rapid NETs test indicated the site of infection in febrile patients postneurosurgery with clinically relevant sensitivity and specificity, which might show its potential to minimize the unnecessary use of antibiotics.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"1 1","pages":"63 - 71"},"PeriodicalIF":0.0,"publicationDate":"2020-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83710740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-06-01DOI: 10.1097/POC.0000000000000204
L. Blairon, A. Wilmet, I. Beukinga, M. Tré-Hardy
Abstract The ISO 22870:2016 standard requires validation of point-of-care testing (POCT) instruments before routine use. Although it is a relatively easy task for blood gas analyzers, it is much more involved in connected blood glucose monitoring (BGM) devices because they are used ubiquitously and in large numbers throughout hospital departments. Here we present the model used in order to validate efficiently and effectively compliance of 116 glucose/ketone BGM devices to ISO 22870. In a first step, a “reference” BGM was established and fully evaluated in comparison to our criterion-standard laboratory method. The 115 remaining connected and hospital-wide distributed BGM devices were then correlated against the “reference” BGM. We spiked donated blood samples with increasing amounts of glucose derived from a diluted oral glucose solution and tested it with the reference StatStrip BGM device and with a cobas 8000 glucose laboratory comparison method. Every connected BGM device was then compared with the BGM reference device using the same sample preparation methodology. The ISO 15197, POCT 12-A3, and Food and Drug Administration performance acceptance criteria were used for comparing the BGM reference results with the laboratory criterion-standard results and for comparing BGM reference results with the connected hospital BGM devices. Repeatability and interassay precision were assessed with aqueous controls. We show that it is possible to validate compliance of a large number of connected POCT BGM devices to ISO 22870 efficiently and effectively using only 1 operator. The StatStrip BGM device performances were excellent and met the ISO 15197, POCT 12-A3, and Food and Drug Administration criteria.
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