From the perspective of the Japan Association of Clinical Reagents Industries

Simple testing conducted in the hospital laboratory and the Commercial Lab is not considered "time-consuming testing" but prompt testing that enables obtaining data near the patient. In the field of medical care, the need for POCT(Point-of-Care Testing) which can test in prompt and minimally invasive ways has been increasing. In a related move, new techniques are being developing one after another to meet those needs. In the future, we will need to appropriately provide intensive service at the central laboratory and prompt service at the bedside while increasing economic efficiency. Because the 21st century is being promoted as the age of self-responsibility, we need to create systems and an environment for patients to manage their own health. In terms of the reduction of medical service fees, it seems that the method of payment directs forward like DRG definitely. Therefore, cooperation among industry and academia is needed to promote OTC test agents as testing before getting a disease and take an active part enlightening the importance of home testing. Currently, long-term medication is administered for an increasing number of chronic ailments going with the aging population. It seems desirable to develop and popularize easy home tests for monitoring chronic ailment and easy test agents for the checking side effects by drug.     

Usefulness of POCT in critical care medicine

The need for speedy and accurate test results is becoming increasingly urgent in the areas of emergency medicine and ICU. The form of emergency testing is changing from conventional testing conducted by laboratory technicians to point-of-care testing (POCT) performed by the doctor or nurse. Therefore, the skill and time of the technician, which used to be expended for emergency testing, is now utilized for maintenance and precision control of POCT equipment so that the doctors and nurses can conduct POCT with confidence at all times. We also attempted point of prehospital care testing (POPCT), comprised of prehospital care and POCT. Here, the laboratory technician rides with the doctor to provide patient information to the clinicians from the perspective of a laboratory technician in the field to support emergency treatment. This has not yet been made fully practical, but the usefulness of POCT in critical care medicine seems to be essential to the forthcoming advanced emergency medicine, considering its usefulness outside the hospital environment.     

Clinically impactful differences in variant interpretation between clinicians and testing laboratories: a single-center experience

PurposeTo describe the frequency and nature of differences in variant classifications between clinicians and genetic testing laboratories.MethodsRetrospective review of variants identified through genetic testing ordered in routine clinical care by clinicians in the Stanford Center for Inherited Cardiovascular Disease. We compared classifications made by clinicians, the testing laboratory, and other laboratories in ClinVar.ResultsOf 688 laboratory classifications, 124 (18%) differed from the clinicians’ classifications. Most differences in classification would probably affect clinical care of the patient and/or family (83%, 103/124). The frequency of discordant classifications differed depending on the testing laboratory (P < 0.0001) and the testing laboratory’s classification (P < 0.00001). For the majority (82/124, 66%) of discordant classifications, clinicians were more conservative (less likely to classify a variant pathogenic or likely pathogenic). The clinicians’ classification was discordant with one or more submitter in ClinVar in 49.1% (28/57) of cases, while the testing laboratory’s classification was discordant with a ClinVar submitter in 82.5% of cases (47/57, P = 0.0002).ConclusionThe clinical team disagreed with the laboratory’s classification at a rate similar to that of reported disagreements between laboratories. Most of this discordance was clinically significant, with clinicians tending to be more conservative than laboratories in their classifications.     

Cerebrospinal fluid (CSF) TRAP. A method to improve CSF laboratory efficiency

Establishment of a procedure termed cerebrospinal fluid (CSF) TRAP ("Transport and Rapid Accessioning for Additional Procedures") allows clinicians to appropriately store, at -75 degrees C, and rapidly access CSF specimens. The CSF TRAP enhances patient care by decreasing the need for repeat lumbar punctures and providing reserve fluid for the following: (1) further CSF testing; (2) repeating questionable test results; and (3) laboratory accidents. The CSF TRAP has been approved for third-party payment because it promotes efficient laboratory utilization by encouraging clinicians to review initial CSF findings before ordering low-yield CSF assays such as the venereal disease research laboratory (VDRL) and cryptococcal antigen latex agglutination tests. Currently, CSF TRAP samples are being obtained with 40% of all CSF acquisitions at the Duke University Medical Center. The availability of the CSF TRAP was associated with a significant decrease in the ordering of CSF VDRL and cryptococcal antigen assays (P less than 0.05); however, there was no significant change in the proportion of those studies being performed on normal CSF. The CSF TRAP procedure provides the framework for an overall restructuring of CSF testing that is being investigated.     

Unreliability of IgE/IgG4 antibody testing as a diagnostic tool in food intolerance

BACKGROUND: Some clinicians link chronic disease in certain patients to 'food intolerance'. This is currently diagnosed by exclusion dieting, a time-consuming and tedious technique. It has been claimed that IgE/IgG4 antibody testing is a rapid and valid method of determining food intolerance. OBJECTIVE: To determine the test/retest reliability of IgE/IgG4 antibody testing as a diagnostic tool. METHODS: Blinded testing of duplicate blood samples from nine patients with suspected food intolerance was undertaken by tertiary referral centre using the services of a commercial laboratory. The proportions of consistent and inconsistent results for tests of 95 different foods were analysed. RESULTS: Test/retest reliability was low. Even though the study method systematically overestimated kappa, this value never exceeded 0.51, regardless of the statistical model used. All but one patient had a greater number of inconsistent results than had been prespecified as an unacceptable level of disagreement. In one case, 50 out of 95 test results were inconsistent on retest. CONCLUSIONS: We found no evidence that IgE/IgG4 antibody testing as performed by this laboratory is a reliable diagnostic tool.     

Laboratory medicine in the obligatory postgraduate clinical training system--common clinical training program in the department of laboratory medicine in our prefectural medical university hospital

I propose a postgraduate common clinical training program to be provided by the department of laboratory medicine in our prefectural medical university hospital. The program has three purposes: first, mastering basic laboratory tests; second, developing the skills necessary to accurately interpret laboratory data; third, learning specific techniques in the field of laboratory medicine. For the first purpose, it is important that medical trainees perform testing of their own patients at bedside or in the central clinical laboratory. When testing at the central clinical laboratory, instruction by expert laboratory technicians is helpful. The teaching doctors in the department of laboratory medicine are asked to advise the trainees on the interpretation of data. Consultation will be received via interview or e-mail. In addition, the trainees can participate in various conferences, seminars, and meetings held at the central clinical laboratory. Finally, in order to learn specific techniques in the field of laboratory medicine, several special courses lasting a few months will be prepared. I think this program should be closely linked to the training program in internal medicine.     

Point-of-care and point-of-‘can’: leveraging reference-laboratory capacity for integrated diagnosis of fever syndromes in the tropics

BackgroundThere is an urgent need for integrated diagnosis of febrile syndromes able to account for multiple pathogens and to inform decisions for clinical care and public health.AimsTo reflect on the evolving roles of laboratory-based testing for non-malarial febrile illnesses (NMFIs) in low-resource settings, and to consider how advances in diagnostics, in connectivity and transport, and in implementation of quality systems may substantially enhance the capacity of reference laboratories to bridge the current gap between remote passive surveillance and clinically meaningful integrated fever diagnosis.SourcesIterative search of PubMed databases, organizational reports, and expert consultation.ContentImplementation of new technologies—such as very broad molecular panels for surveillance and mass spectrometry—may considerably diminish capability gaps in reference laboratories in low-resource settings. Although the need for clinical bacteriology diagnostics is now recognized, the lack of new simple and rapid phenotypic tests for antimicrobial resistance remains a key deficiency. Several initiatives to strengthen diagnostic preparedness for infectious disease outbreaks have highlighted the need for functional tiered laboratory networks. Recently, dramatic headway in connectivity—such as combining automated readers with the image processing and data transmission capabilities of smartphones—now allows for more complex testing and interfacing with distant laboratory information systems while reducing workload and errors. Together with connectivity to transmit and receive results, new approaches to specimen collection and transport—such as the validation of rectal swabs and the use of aerial drones to transport specimens to distant laboratories—now make remote testing feasible. The above innovations also open up the possibility of implementing quality systems through community-level diagnostic stewardship. Finally, strengthened laboratory networks actively support the feasibility of implementing quality-assured point-of-care testing where it is needed.ImplicationsRecent advances offer the present-day possibility of innovations to re-invent the relationship between distant reference laboratories and end-users for integrated diagnosis of NMFIs.     

Evaluation of the bedside Quikread go® CRP test in the management of febrile infants at the emergency department

Recently C-reactive protein (CRP) point-of-care tests have been developed. We aimed to validate a bedside CRP test (QuikRead go® CRP), to compare it with the laboratory CRP (ARCHITECT c8000 Abbott, Germany) test in children with fever without source (FWS), and to evaluate the optimal CRP cut-off value to identify those patients at a high risk for serious bacterial infection (SBI). The CRP bedside test was prospectively performed in capillary blood samples concurrently with the laboratory CRP testing for 283 well-appearing infants aged 1 to 24 months with FWS attending the emergency department (ED) between May 2013 and August 2015. The mean difference between the laboratory CRP and the QuikRead go CRP values was 0.71 mg/L (p?=?0.444). Pearson’s correlation coefficient between the CRPs was r?=?0.929 (p?<?0.001). SBI was diagnosed in 34 patients (12.0%). The area under the receiver operating characteristics (ROC) curve obtained was 0.87 (95%CI: 0.82–0.90) for an optimal CRP cut-off value of?>?10 mg/L (sensitivity: 94.1%, specificity: 49.0%, positive predictive value: 20.1%, negative predictive value: 98.4%), as a predictor of SBI. Nearly 45% of the patients were at a low risk for SBI according to CRP value; thus, additional laboratory tests would have been hypothetically avoided. There was a very strong, positive correlation between the QuikRead go CRP test and laboratory CRP determination. The QuikRead go CRP test provides reliable results to rule out SBI. Its implementation at the ED would improve the management of infants with FWS.     

Review of the clinical activity of medical microbiologists in a teaching hospital

BACKGROUND: The clinical interactive role of medical microbiologists has been underestimated and the discipline is perceived as being confined to the laboratory. Previous studies have shown that most microbiology interaction takes place over the telephone. AIM: To determine the proportion of clinical ward based and laboratory based telephone interactions and specialties using a microbiology service. METHODS: Clinical microbiology activity that took place during November 1996 was prospectively analysed to determine the distribution of interactions and specialties using the service. RESULTS: In all, 1177 interactions were recorded, of which nearly one third (29%) took place at the bedside and 23% took place on call. Interactions involving the intensive treatment unit, general ward visits, and communication of positive blood cultures and antibiotic assays were the main areas of activity identified. There were 147 visits to 86 patients on the general wards during the study, with the number of visits to each individual varying from one to eight. The need for repeated visits reflected the severity of the underlying condition of the patients. Ward visits were regarded as essential to obtain missing clinical information, to assess response to treatment, and to make an appropriate entry in a patient's notes. CONCLUSIONS: Ward visits comprise a significant proportion of clinical microbiology interactions and have potential benefits for patient management, service utilisation, and education.     

Routine use of point-of-care tests: usefulness and application in clinical microbiology

Point-of-care (POC) tests offer potentially substantial benefits for the management of infectious diseases, mainly by shortening the time to result and by making the test available at the bedside or at remote care centres. Commercial POC tests are already widely available for the diagnosis of bacterial and viral infections and for parasitic diseases, including malaria. Infectious diseases specialists and clinical microbiologists should be aware of the indications and limitations of each rapid test, so that they can use them appropriately and correctly interpret their results. The clinical applications and performance of the most relevant and commonly used POC tests are reviewed. Some of these tests exhibit insufficient sensitivity, and should therefore be coupled to confirmatory tests when the results are negative (e.g. Streptococcus pyogenes rapid antigen detection test), whereas the results of others need to be confirmed when positive (e.g. malaria). New molecular-based tests exhibit better sensitivity and specificity than former immunochromatographic assays (e.g. Streptococcus agalactiae detection). In the coming years, further evolution of POC tests may lead to new diagnostic approaches, such as panel testing, targeting not just a single pathogen, but all possible agents suspected in a specific clinical setting. To reach this goal, the development of serology-based and/or molecular-based microarrays/multiplexed tests will be needed. The availability of modern technology and new microfluidic devices will provide clinical microbiologists with the opportunity to be back at the bedside, proposing a large variety of POC tests that will allow quicker diagnosis and improved patient care.     

Morning rounds inpatient test availability: a College of American Pathologist Q-Probes study of 79860 morning complete blood cell count and electrolyte test results in 367 institutions

OBJECTIVES: To determine the success with which laboratories were able to report morning test results on time, the laboratory practice characteristics associated with improved success, and the degree of satisfaction among clinicians with the timeliness of laboratory service. DESIGN: Hospital laboratories participating in the College of American Pathologist Q-Probes laboratory quality improvement program prospectively calculated the percentages of morning-run complete blood cell count (CBC) and electrolyte results that were reported on or before predetermined reporting deadlines, completed questionnaires concerning their departments' practice characteristics as they related to performing morning blood work, and distributed to physician utilizers of morning laboratory services questionnaires evaluating physician satisfaction with laboratory services. SETTING AND PARTICIPANTS: A total of 367 public and private institutions located in the United States (355), Canada (5), Australia (2), and 1 each in the United Kingdom, Spain, Brazil, Korea, and Guam. MAIN OUTCOME MEASURE: The percentages of morning-run CBC and electrolyte results reported on or before predetermined reporting deadlines. RESULTS: Participants submitted data on 40 256 CBC and 39 604 electrolyte specimens. In aggregate, a total of 88.9% of these tests (90.2% of CBCs and 87.6% of electrolytes) were reported on or before the reporting deadlines that the participating laboratories set for themselves. Half of the participants reported 94.6% of their CBC results and 95.5% of their electrolyte results on or before their self-imposed reporting deadlines. No specific demographic features or departmental practice characteristics were associated with higher or lower rates of institutional reporting compliance. Most physician utilizers of early-morning laboratory test results believed that the laboratory is sensitive to and meets the needs of clinicians for timely reporting of early-morning test results. CONCLUSIONS: Most laboratories are capable of reporting 95% of their routine morning laboratory tests on time, and most physicians are satisfied with their laboratories' morning testing service.     

Audit of the clinical usefulness of a rapid qualitative ELISA screen for antimyeloperoxidase and antiproteinase 3 antibodies in the assessment of patients with suspected vasculitis

BACKGROUND: The need for urgent antineutrophil cytoplasmic antibody (ANCA) results when assessing patients with acute renal failure, pulmonary renal syndrome, or mononeuritis multiplex has led to the development of a rapid qualitative ELISA screening assay for antibodies to myeloperoxidase (MPO) and proteinase 3 (PR3). AIMS: To report the use of a rapid qualitative ELISA screen for PR3-ANCA and MPO-ANCA in a regional immunology laboratory and its correlation with standard indirect immunofluorescence (IIF) and quantitative ELISA for PR3-ANCA and MPO-ANCA. METHODS: Over 12 months, 103 samples requiring urgent ANCA testing were screened by a rapid qualitative ELISA and the results compared with IIF and quantitative ELISA assays for PR3-ANCA and MPO-ANCA. RESULTS: There was an excellent correlation between the rapid qualitative ELISA and standard ANCA IIF and a routine ELISA for MPO/PR3-ANCA, with sensitivities ranging from 82% to 100%. There were two false negatives, which gave weak to moderately positive values as determined by routine ELISA. However, the clinical relevance of these two cases is doubtful. CONCLUSIONS: The rapid ELISA for anti-MPO and anti-PR3 correlates well with quantitative ELISA and IIF ANCA, and urgent management decisions in patients with suspected small vessel vasculitis can be based with confidence on this test.     

Getting the right blood to the right patient: the contribution of near-miss event reporting and barrier analysis.

Safety and reliability in blood transfusion are not static, but are dynamic non-events. Since performance deviations continually occur in complex systems, their detection and correction must be accomplished over and over again. Non-conformance must be detected early enough to allow for recovery or mitigation. Near-miss events afford early detection of possible system weaknesses and provide an early chance at correction. National event reporting systems, both voluntary and involuntary, have begun to include near-miss reporting in their classification schemes, raising awareness for their detection. MERS-TM is a voluntary safety reporting initiative in transfusion. Currently 22 hospitals submit reports anonymously to a central database which supports analysis of a hospital's own data and that of an aggregate database. The system encourages reporting of near-miss events, where the patient is protected from receiving an unsuitable or incorrect blood component due to a planned or unplanned recovery step. MERS-TM data suggest approximately 90% of events are near-misses, with 10% caught after issue but before transfusion. Near-miss reporting may increase total reports ten-fold. The ratio of near-misses to events with harm is 339:1, consistent with other industries' ratio of 300:1, which has been proposed as a measure of reporting in event reporting systems. Use of a risk matrix and an event's relation to protective barriers allow prioritization of these events. Near-misses recovered by planned barriers occur ten times more frequently then unplanned recoveries. A bedside check of the patient's identity with that on the blood component is an essential, final barrier. How the typical two person check is performed, is critical. Even properly done, this check is ineffective against sampling and testing errors. Blood testing at bedside just prior to transfusion minimizes the risk of such upstream events. However, even with simple and well designed devices, training may be a critical issue. Sample errors account for more than half of reported events. The most dangerous miscollection is a blood sample passing acceptance with no previous patient results for comparison. Bar code labels or collection of a second sample may counter this upstream vulnerability. Further upstream barriers have been proposed to counter the precariousness of urgent blood sample collection in a changing unstable situation. One, a linking device, allows safer labeling of tubes away from the bedside, the second, a forcing function, prevents omission of critical patient identification steps. Errors in the blood bank itself account for 15% of errors with a high potential severity. In one such event, a component incorrectly issued, but safely detected prior to transfusion, focused attention on multitasking's contribution to laboratory error. In sum, use of near-miss information, by enhancing barriers supporting error prevention and mitigation, increases our capacity to get the right blood to the right patient.     

Diagnostic approach to acute diarrheal illness in a military population on training exercises in Thailand, a region of campylobacter hyperendemicity

High rates of Campylobacter fluoroquinolone resistance highlight the need to evaluate diagnostic strategies that can be used to assist with clinical management. Diagnostic tests were evaluated with U.S. soldiers presenting with acute diarrhea during deployment in Thailand. The results of bedside and field laboratory diagnostic tests were compared to stool microbiology findings for 182 enrolled patients. Campylobacter jejuni was isolated from 62% of the cases. Clinical and laboratory findings at the time of presentation were evaluated to determine their impact on the posttest probability, defined as the likelihood of a diagnosis of Campylobacter infection. Clinical findings, the results of tests for inflammation (stool occult blood testing [Hemoccult], fecal leukocytes, fecal lactoferrin, plasma C-reactive protein), and the numbers of Campylobacter-specific antibody-secreting cells in peripheral blood failed to increase the posttest probability above 90% in this setting of Campylobacter hyperendemicity when these findings were present. Positive results by a Campylobacter-specific commercial enzyme immunoassay (EIA) and, less so, a research PCR were strong positive predictors. The negative predictive value for ruling out Campylobacter infection, defined as a posttest probability of less than 10%, was similarly observed with these Campylobacter-specific stool-based tests as well the fecal leukocyte test. Compared to the other tests evaluated, the Campylobacter EIA is a sensitive and specific rapid diagnostic test that may assist with diagnostic evaluation, with consideration of the epidemiological setting, logistics, and cost.     

A case of free-living Amoebae keratitis in a non contact lens wearer

Free living amoebae keratitis is a rare but severe infection due to ubiquitous protozoa of the genus Acanthamoeba. Most cases occur in contact lens wearers. In the present paper, we report a case of Acanthamoeba keratitis secondary to a vegetal injury of the cornea in a patient who did not wear contact lens. This case emphasizes the fact that the visual outcome is dependent on early treatment and outlines the need for a rapid diagnosis of amoebic keratitis. The diagnosis is based essentially on culture of trophozo?tes and cysts of the parasite from a corneal scrape or a biopsy specimen. The treatment is long, difficult and often a failure. Successful management of amoebic keratitis infection thus requires constant dialogue between the physician and the clinical microbiologist, a quality sample and efficient laboratory tests.     

Mobile and Fixed Computer Use by Doctors and Nurses on Hospital Wards: Multi-method Study on the Relationships Between Clinician Role,Clinical Task,and Device Choice

Background

Selecting the right mix of stationary and mobile computing devices is a significant challenge for system planners and implementers. There is very limited research evidence upon which to base such decisions.

Objective

We aimed to investigate the relationships between clinician role, clinical task, and selection of a computer hardware device in hospital wards.

Methods

Twenty-seven nurses and eight doctors were observed for a total of 80 hours as they used a range of computing devices to access a computerized provider order entry system on two wards at a major Sydney teaching hospital. Observers used a checklist to record the clinical tasks completed, devices used, and location of the activities. Field notes were also documented during observations. Semi-structured interviews were conducted after observation sessions. Assessment of the physical attributes of three devices—stationary PCs, computers on wheels (COWs) and tablet PCs—was made. Two types of COWs were available on the wards: generic COWs (laptops mounted on trolleys) and ergonomic COWs (an integrated computer and cart device). Heuristic evaluation of the user interfaces was also carried out.

Results

The majority (93.1%) of observed nursing tasks were conducted using generic COWs. Most nursing tasks were performed in patients’ rooms (57%) or in the corridors (36%), with a small percentage at a patient’s bedside (5%). Most nursing tasks related to the preparation and administration of drugs. Doctors on ward rounds conducted 57.3% of observed clinical tasks on generic COWs and 35.9% on tablet PCs. On rounds, 56% of doctors’ tasks were performed in the corridors, 29% in patients’ rooms, and 3% at the bedside. Doctors not on a ward round conducted 93.6% of tasks using stationary PCs, most often within the doctors’ office. Nurses and doctors were observed performing workarounds, such as transcribing medication orders from the computer to paper.

Conclusions

The choice of device was related to clinical role, nature of the clinical task, degree of mobility required, including where task completion occurs, and device design. Nurses’ work, and clinical tasks performed by doctors during ward rounds, require highly mobile computer devices. Nurses and doctors on ward rounds showed a strong preference for generic COWs over all other devices. Tablet PCs were selected by doctors for only a small proportion of clinical tasks. Even when using mobile devices clinicians completed a very low proportion of observed tasks at the bedside. The design of the devices and ward space configurations place limitations on how and where devices are used and on the mobility of clinical work. In such circumstances, clinicians will initiate workarounds to compensate. In selecting hardware devices, consideration should be given to who will be using the devices, the nature of their work, and the physical layout of the ward.     

Rapid microbiological tests for bloodstream infections due to multidrug resistant Gram-negative bacteria: therapeutic implications

BackgroundTreating severe infections due to multidrug-resistant Gram-negative bacteria (MDR-GNB) is one of the most important challenges for clinicians worldwide, partly because resistance may remain unrecognized until identification of the causative agent and/or antimicrobial susceptibility testing (AST). Recently, some novel rapid test for identification and/or AST of MDR-GNB from positive blood cultures or the blood of patients with bloodstream infections (BSIs) have become available.ObjectivesThe objective of this narrative review is to discuss the advantages and limitations of different rapid tests for identification and/or AST of MDR-GNB from positive blood cultures or the blood of patients with BSI, as well as the available evidence on their possible role to improve therapeutic decisions and antimicrobial stewardship.SourcesInductive PubMed search for publications relevant to the topic.ContentThe present review is structured in the following way: (a) rapid tests on positive blood cultures; (b) rapid tests directly on whole blood; (c) therapeutic implications.ImplicationsNovel molecular and phenotypic rapid tests for identification and AST show the potential for favourably influencing patients' outcomes and results of antimicrobial stewardship interventions by reducing both the time to effective treatment and the misuse of antibiotics, although the interpretation about their impact on actual therapeutic decisions and patients' outcomes is still complex. Factors such as feasibility and personnel availability, as well as the detailed knowledge of the local microbiological epidemiology, need to be considered very carefully when implementing novel rapid tests in laboratory workflows and algorithms. Providing high-level, comparable evidence on the clinical impact of rapid identification and AST is becoming of paramount importance for MDR-GNB infections, since in the near future rapid identification of specific resistance mechanisms could be crucial for guiding rapid, effective, and targeted therapy against specific resistance mechanisms.     

Reliability and feasibility of a near patient test for C-reactive protein in primary care.

BACKGROUND: The applications of new diagnostic technologies such as near patient tests are relevant to the further development and potential of primary care. Through their use, doctors in the community may increase the accuracy of their diagnoses and improve their ability to monitor disease. A reliable indicator of disease activity in various clinical conditions is C-reactive protein (CRP) and a near patient test for this is now available, although there is little information on its use outside hospitals. AIM: A study was set up to evaluate the feasibility of using a novel near patient test for CRP in primary care to validate the results against the laboratory "gold standard' for CRP (Beckman Array) and to compare results with the usual inflammation test used in general practice. METHOD: Prospective recording of CRP as a near patient test on an "intention to investigate' basis, with validation of results against the Beckman Array system for CRP and hospital laboratory erythrocyte sedimentation rate results, in six general medical practices in Birmingham. Main outcome measures were change in local laboratory usage, characteristics of patients chosen for testing, use of quality control, and comparison of readings with results from the same sample sent to an independent laboratory. RESULTS: Tests of CRP levels were rarely requested before the study was undertaken. During the 3-month study period, 181 near patient tests were carried out, 146 (81%) to establish a diagnosis and the remainder for disease monitoring. Out of the tests, 67% were performed by general practitioners, mostly during the consultation itself. Using a cut-off level of 10 mg I-1, the near patient test and the Beckman Array gave results which agreed in 84% of cases. The sensitivity and specificity of the near patient test results were 97 and 79%, respectively. The predictive value of a positive result was 59% and that of a negative result was 99%. Cohen's Kappa was 62% and the overall mean bias for results in the range of the test was 6.11 mg I-1 (SE = 3.07 mg I-1). Each test took 6 min on average to perform, including all preparations, blood letting, performing the test and averaging the time for quality control estimations. The cost per test averaged pounds 1.72, rising to pounds 4.17 including labour, capital costs, quality controls and consumables (general practitioner performing the assay at average frequency found in this study). CONCLUSIONS: Measurement of CRP is rarely used in primary care and awareness of its value could be raised. This near patient test proved feasible for use by general practitioners and practice nurses. Its reliability compared with a laboratory result was satisfactory overall, and excellent with adequate operator technique.     

A primary care evaluation of three near patient coagulometers

AIM: To compare the reliability and relative costs of three international normalised ratio (INR) near patient tests. MATERIALS: Protime (ITC Technidyne), Coaguchek (Boehringer Mannheim), and TAS (Diagnostic Testing). METHODS: All patients attending one inner city general practice anticoagulation clinic were asked to participate, with two samples provided by patients not taking warfarin. A 5 ml sample of venous whole blood was taken from each patient and a drop immediately added to the prepared Coaguchek test strip followed by the Protime cuvette. The remainder was added to a citrated bottle. A drop of citrated blood was then placed on the TAS test card and the remainder sent to the reference laboratory for analysis. Parallel INR estimation was performed on the different near patient tests at each weekly anticoagulation clinic from July to December 1997. RESULTS: 19 patients receiving long term warfarin treatment provided 62 INR results. INR results ranged from 0.8-8.2 overall and 1.0-5.7 based on the laboratory method. Taking the laboratory method as the gold standard, 12/62 results were < 2.0 and 2/62 were > 4.5. There were no statistical or clinically significant differences between results from the three systems, although all near patient tests showed slightly higher mean readings than the laboratory, and 19-24% of tests would have resulted in different management decisions based on the machine used in comparison with the laboratory INR value. The cost of the near patient test systems varied substantially. CONCLUSIONS: All three near patient test systems are safe and efficient for producing acceptable and reproducible INR results within the therapeutic range in a primary care setting. All the systems were, however, subject to operator dependent variables at the time of blood letting. Adequate training in capillary blood sampling, specific use of the machines, and quality assurance procedures is therefore essential.