HemoTypeSC point-of-care testing shows high sensitivity with alkaline cellulose acetate hemoglobin electrophoresis for screening hemoglobin SS and SC genotypes

ABSTRACT Introduction: By providing timely actionable results for prompt management, point-of-care testing (POCT) kits have revolutionised medical care for various diseases, ranging from infectious diseases like malaria to genetic disorders, such as sickle cell disease (SCD). They are, however, underutilised in the diagnosis of SCD in developing countries, where the need is greatest. Objective: The study was aimed at assessing the sensitivity of HemoTypeSC POCT among a cohort of children with SCD, previously diagnosed by Alkaline cellulose acetate hemoglobin electrophoresis (ACAE), with or without high-performance liquid chromatography (HPLC). Methods: In this descriptive cross-sectional study, HemoTypeSC test was conducted on all participants and its sensitivity was determined by comparing results with those obtained using ACAE. Discordance was verified with HPLC. Results: One hundred and forty-five children aged one to 19 years were studied. There were 84 males and 61 females (male: female ratio = 1.4:1). The HemoTypeSC was able to correctly diagnose sickle cell anemia (SCA) and hemoglobin SC in all (100%) of the children tested. Conclusion: The HemoTypeSC shows high sensitivity in detecting SCA and hemoglobin SC. Hence, it is useful for targeted screening of individuals suspected of having SCD, leading to rapid diagnosis of these hemoglobinopathies, even in resource-constrained settings.

Utility of Vaginal pH as Point of Care Test for Detection of Bacterial Vaginosis

Background & objectives: Bacterial vaginosis (BV) is a Reproduc?ve tract infec?on (RTI) among young sexually ac?ve women with high prevalence. It is associated with complica?ons related to pregnancy and an increased risk of acquiring STDs. This poses a need for cost-effec?ve detec?on of BV in low resource se?ngs. Hence, we propose to study the u?lity of vaginal pH determina?on for the detec?on of BV. Material & Methods: This is a single center, 1 year cross-sec?onal study. Swabs were collected from 250 non-pregnant women a?ending the out-pa?ent department of Obstetrics and Gynecology with vaginal discharge as a predominant symptom with or without backache and abdominal pain. Vaginal pH determina?on, Gram stain, wet mount, Whiff test, and Amsel’s criteria were used for BV detec?on. Results: 250 study par?cipants with vaginal discharge sugges?ve of BV were analyzed. Vaginal pH was significantly higher in women with BV with the mean pH being 6.2. Vaginal pH >4.5 had a sensi?vity of 85% and specificity of 66% to detect BV. The Whiff test had the least sensi?vity. Clue cells and Amsel’s criteria of ? 3 were significant for BV. A combina?on of pH and Whiff test performed be?er had high sensi?vity and specificity. Conclusions: A combina?on of pH determina?on and the Whiff test serves as a low-cost alterna?ve in resource-poor se?ngs for detec?on of BV. Though Clue cells and Amsel’s criteria ? 3 were most sensi?ve and specific, they cannot be used in low resource se?ngs. Vaginal pH alone can be used to detect BV in areas of low prevalence.

Evaluation of urine L-FABP Point of care kit in the Philippines as predictive marker of clinical severity of COVID-19 (EPOCH COVID study)

Background@#The search for simple clinical and laboratory markers to help predict the clinical severity of patients presenting with COVID-19 has prompted this study to look at the predictive value of urine L-FABP (Liver Type-Fatty Acid Binding Protein) point-of-care test kit at the initial presentation of COVID-19 patients to the hospital.@*Methods@#The validation study prospectively included 109 consecutive patients with mild to moderate COVID-19, mean age of 52.2 years (range 19-84) presenting at the Emergency Rooms of 4 participating Metro-Manila hospitals from February to April 2021, with available data for analysis for 103 patients. Urine L-FABP POC (Point-of-Care) test and other clinical parameters and the level of severity of COVID-19 were determined at Day 0, Day 4 and Day 7. Computations for Sensitivity, Specificity, Positive and Negative Predictive values and Likelihood ratios were performed.@*Results@#Twenty-three patients tested positive for urine L-FABP, out of the 103 patients analyzed, while 80 tested negative. Of the 23 patients who tested positive for urine L-FABP, 6 has progressed in severity, while 17 did not progressed. Of the 80 patients who tested negative for urine L-FABP, 13 progressed, while 67 did not progressed in severity. Giving a Sensitivity of 31.58%, Specificity of 79.76%, Positive predictive value of 26.09%, Negative predictive value of 83.75%. Combining urine L-FABP and initial clinical parameters like SIRS (Systemic Inflammatory Response Syndrome) criteria to predict progression of severity yielded a higher Specificity of 91.67 % and Negative Predictive value of 84.62%.@*Conclusions@#The study shows the utility of initial urine L-FABP POC test as a negative screening test in triaging adult patients presenting to the ER with mild to moderate COVID-19. Patients at the ER with a negative urine L-FABP test, will most likely not progressed to severe COVID-19. Combining clinical parameters like SIRS Criteria with the urine L-FABP result can increase the negative predictive value.

Rapid Molecular Point of Care Testing for Detection of Influenza A, B Viruses and Respiratory Syncytial Virus Versus Multiplex PCR

@#Introduction: Rapid detection of influenza viruses and respiratory syncytial virus (RSV) can be achieved by having rapid molecular point of care tests (POCTs). This expedites the diagnosis attributed by having similar clinical presentations leading to facilitation of precision medicine and reduction of antimicrobial resistance. The growing number of POCTs foster the need to ensure that these POCTs have satisfactory and reliable performance. With that the aim of this study is to evaluate the performance of rapid molecular POCT regarded as ‘X’ for the detection of Influenza viruses and RSV in comparison to multiplex PCR. Methods: A laboratory-based study was conducted from January to December 2020 which involved analysis of 116 nasopharyngeal swabs, tested using POCT X and multiplex PCR as a method of reference. The performance analysis incorporated the sensitivity, specificity, positive and negative predicted values determination. The cycle threshold values were reviewed for discordant results. Results: The POCT X demonstrated sensitivity of 88.57% with 100% specificity for Influenza A virus, and 85.71% of sensitivity with 100% specificity for influenza B virus detection. Meanwhile it revealed 100% sensitivity and specificity for RSV detection. There were ten specimens demonstrating discordant results whereby viruses were not detected by POCT X, however detected by multiplex PCR. The POCT X was not able to detect eight (12.9%) and two (16.7%) influenza A and B viruses respectively. Conclusion: The overall performance of POCT X was corresponded to multiplex PCR. This best served as a steadfast ancillary test for influenza and RSV infection.

Comparison of two commercial tests (Immy vs. Dynamiker) for cryptococcal capsular antigen

Abstract INTRODUCTION Lateral flow assay is an advanced method useful in the early diagnosis of cryptococcal meningitis. We aimed to compare two commercial tests for cryptococcal capsular antigen in the sera of asymptomatic patients with human immunodeficiency virus in Barranquilla, Colombia. METHODS Thawed (n=162) previously collected serums (2016-2019) were processed using IMMY and Dynamiker cryptococcal antigen lateral flow assay. RESULTS Compared to IMMY's results, Dynamiker's sensitivity, specificity, positive predictive value, negative predictive value, and kappa index were 100%, 89.9%, 48.3%, 100.0%, and 0.61, respectively. CONCLUSIONS The Dynamiker test had excellent sensitivity, acceptable specificity, and a low detection threshold for cryptococcal antigen in the tested samples.

The usefulness of fecal calprotectin in assessing inflammatory bowel disease activity

BACKGROUND/AIMS: Fecal calprotectin (FC) is known to correlate with disease activity and can be used as a predictor for relapse or treatment response in inflammatory bowel disease (IBD). We evaluated the usefulness of FC as a biomarker for disease activity in patients with IBD using both enzyme-linked immunosorbent assay (ELISA) and a quantitative point-of-care test (QPOCT). METHODS: Fecal samples and medical records were collected from consecutive patients with IBD. FC levels were measured by both ELISA and QPOCT and patient medical records were reviewed for clinical, laboratory, and endoscopic data. RESULTS: Ninety-three patients with IBD were enrolled, 55 with ulcerative colitis (UC) and 38 with Crohn's disease (CD). The mean FC-ELISA levels were 906.3 ± 1,484.9 μg/g in UC and 1,054.1 ± 1,252.5 μg/g in CD. There was a strong correlation between FC-ELISA level and clinical activity indices (p < 0.05). FC-ELISA level was significantly lower in patients with mucosal healing (MH) compared to those without MH in UC (85.5 ± 55.6 μg/g vs. 1,503.7 ± 2,129.9 μg/g, p = 0.005). The results from the QPOCT corresponded well to those from ELISA. A cutoff value of 201.3 μg/g for FC-ELISA and 150.5 μg/g for FC-QPOCT predicted endoscopic inflammation (Mayo endoscopic subscore ≥ 1) in UC with a sensitivity of 81.8% and 85.8%, respectively, and a specificity of 100% for both. CONCLUSIONS: FC was strongly associated with disease activity indices, serologic markers, and endoscopic activity in patients with IBD. QPOCT can be used more conveniently than ELISA to assess FC in clinical practice.

Water, sanitation and hygiene survey – Use of hydrogen sulfide strip at field level as a point-of-care test: A pilot study

Safe drinking water is a basic element of primary health care. The government of India in its Indian Public Health Standards recommends the hydrogen sulfide (H2S) strip test as a desirable component at primary health centers for screening water for fecal coliforms. The objective of the present study was to conduct a water, sanitation and hygiene (WASH) survey followed by a H2S strip test of drinking water in a village with ninety households. The test was positive in 88% at the source and the point of consumption, with 100% concordance between both the points of test. A subsample of water samples was subjected to testing in microbiology laboratory, and fecal contamination was confirmed in all of them. To conclude, H2S strip test can be conveniently used at field level, and its ease of use and visual nature of results make it a useful point-of-care test of environmental and public health.

A Low-dose human fibrinogen is not effective in decreasing postoperative bleeding and transfusion requirements during cardiac surgery in case of concomitant clinical bleeding and low FIBTEM values: A retrospective matched study

Background: Studies evaluating the hemostatic effects of fibrinogen administration in cardiac surgery are not conclusive. Aims: We investigated whether the use of a low-dose human fibrinogen in case of clinical bleeding after protamine administration and concomitant low FIBTEM values is effective in reducing postoperative bleeding. Secondary end-point was to investigate the consumption of allogeneic blood products. Setting and Design: This was a retrospective matched study conducted at university hospital. Materials and Methods: Among 2257 patients undergoing surgery with cardiopulmonary (CPB) bypass, 73 patients received a median dose of 1 g human fibrinogen (ROTEM-Fibri group). This group was matched with 73 patients who had not received human fibrinogen (control group) among 390 patients having undergone surgery at the moment FIBTEM analysis was unavailable. Statistical Analysis: Matching was performed for the type and the presence of redo surgery. McNemar and Wilcoxon paired tests were used to respectively compare the categorical and quantitative variables. Results: The CPB bypass time was significantly higher in the ROTEM-Fibri group (P = 0.006). This group showed significantly higher bleeding in the first 12 and 24 h postoperatively (P < 0.001) and required significantly more transfusion of blood products (P < 0.001) and surgical revision (P = 0.007) when compared with the control group. There was no significant difference in the number of thromboembolic complications. Conclusions: These results show that the administration of 1 g of fibrinogen based on low-FIBTEM values and clinical bleeding after protamine administration does not stop bleeding and the need for transfusion of allogeneic blood products.

Clinical validation of ImmuneCheck IgE for the rapid detection of serum total IgE

PURPOSE: Conventional serum IgE assay was costly, required the skills of expert, and relied heavily on expensive equipment. Quantitative measurement of total IgE using Point of Care Test (POCT) device can be the solution for these limitations. This study evaluated and validated the reproducibility of ImmuneCheck IgE. METHODS: This study included 120 patients of allergic diseases such as allergic rhinitis, asthma, drug allergy, food allergy, atopic dermatitis, or anaphylaxis . The reliability of POCT ImmuneCheck IgE was evaluated by comparing results from the naked eye and from the Q-Reader. Intratest reproducibility and intertest correlation were analyzed using intraclass correlation coefficient (ICC). RESULTS: Of the 120 enrolled patients, 51 were males and 69 were females. The ages ranged from 19 to 84 years, with an average age of 51.5 years. The concentration of serum total IgE measured by Phadia ImmunoCAP IgE ranged from 5.95 to 5,000 IU/mL. ICC for Intratest reproducibility of ImmuneCheck IgE by naked eye and by Q-Reader were 0.991 (P < 0.001) and 0.989 (P < 0.001), respectively. In addition, intertest correlation between ImmuneCheck IgE and Phadia ImmunoCAP IgE results of naked eye and Q-Reader were 0.968 (P < 0.001) and 0.948 (P < 0.001), respectively. CONCLUSION: The ImmuneCheck IgE was reproducible and highly correlated with conventional Phadia ImmunoCAP IgE assay. This result suggests that ImmuneCheck IgE can be a useful tool for rapid and precise detection of total IgE.

The value of using B-type natriuretic peptide and D-dimer in preliminary recognition of cardioembolic stroke patients / 实用医学杂志

Objective To determine the value of using B-type natriuretic peptide (BNP) and D-dimer in preliminary recognition of cardioembolic stroke patients.Methods A mutilple-center study was conducted in Foshan Hospital of traditional Chinese Medicine (TCM) and its affiliated hospitals from July 2015 to July 2016.In the emergency departments (EDs),emergency physicians prospectively assessed consecutive adult patients with acute cardioembolic stroke and measured plasma BNP by POCT platform on admission,then followed up.Stroke neurologists evaluated patients' functional outcome at hospital discharge and also made discharge diagnosis and stroke etiologic subtypes according to the TOAST criteria.Results In this study,290 acute ischemic stroke patients met the study criteria [mean age (68.41 ± 12.06) years;53.8％ female].Of the enrolled patients,28.3％ were diagnosed with LAA at discharge,17.9％ with CE,42.8％ with SAO,11.0％ with SOE or SUE.And the mean BNP concentration was significantly higher in the CE group than that in other three subtypes (P ＜ 0.001).After adjustment for multiple clinical predictors like gender,age,coronary artery disease,atrial fibrillation and renal function,BNP and D-dimer were associated with CE [BNP OR:1.044 (95％ CI 1.025,1.064),P ＜ 0.001;D-dimer OR:1.511(95％ CI 1.020,2.238),P =0.039,respectively].Conclusion Through POCT technique in the EDs,cardioembolic stroke patients can be differentiated from other TOAST subtypes.BNP with/without D-dimer has good but different corresponding diagnostic performance in preliminary recognition of cardioembolic stroke patients.

Performance verification and field applicability evaluation of biochemical modules in field POCT system(type A) / 军事医学

Objective To evaluate the performance of emergency test and the applicability under complex field conditions of biochemical modules of field point-of-care test ( POCT ) system ( type A ) .Methods The precision and anti-interference ability of albumin ( ALB ) , total bilirubin ( TBIL ) , alanine transaminase ( ALT ) , aspartate transaminase (AST),blood area nitrogen(BUN),creatinine(CREA),uric acid(UA),lactate dohydrogenase(LDH),creatine kinase ( CK) ,and glucose( GLU) detected by field POCT system( A) were analyzed according to standards formulated by National Committee for Clinical Laboratory Standards(NCCLS).Field POCT system(A) and Coulter Beckman AU2700 automatic biochemical analyzer were used to detect the serum of 22 clinical cases respectively.After simulating the field environment by adjusting the temperature and humidity, we compared the results of mixed serum under different environment conditions. Results The coefficients of variation in total precision of ALB,TBIL,ALT,AST,BUN,CREA,UA,LDH,CK,and GLU detected by field POCT system(A) were 3.34%,6.54%,6.01%,4.80%,3.95%,5.59%,3.33%,6.19%,7.40%,and 4.56%(LevelⅠ);and 3.08%,4.47%,4.02%,4.31%,3.76%,4.22%,2.93%,5.25%,6.39%,and 4.35%(LevelⅡ) respectively.When triglycerides( TG) level was at 21 mmol/L, the interference rate was below 10%.When bilirubin level was at 120 μmol/L, the interference rate of ALT,AST and CREA was -33.33%,-22.99%,20.00%(LevelⅠ), and -22.13%,-14.55%,and 8.70%(LevelⅡ),respectively.When its level was at 240 μmol/L, the interference rate of UA was -16.67%and -24.69%, respectively at two levels;if hemoglobin( Hb) was at 170 mg/dl, the interference rate of TBIL and LDH was 20.00%,and 99.26%(LevelⅠ),and 15.38%,and 40.79%(LevelⅡ),respectively;if it was at 340 mg/dl, the interference rate of ALT and AST was 9.84% and 13.79%(LevelⅠ), and 12.30%,and 12.27%(LevelⅡ),respectively;if it was at 510 mg/dl, the interference rate of CREA,UA and Ck in LevelⅠwas 26.67%, 16.67%,and 11.74%.The R2 of linear regression between field POCT system( A) and AU2700 automatic biochemical analyzer were 0.961,0.995,0.989,0.995,0.990,0.989,0.989,0.963,0.978,and 0.993, respectively.The POCT system could not work at 35℃ or higher temperature, and there was no difference in the results of detection between temperatures of 10-30℃or RH of 70%-90% and normal temperature and humidity(20℃,RH 50%) (P>0.05). However, the result of ALT and CK at high temperature and humidity was significantly higher than at normal temperature and humidity(P<0.001,and P=0.011, respectively).Conclusion The biochemical module of field POCT system(A) has a good correlation with the common large biochemical analyzer, and its precision meets the requirement of laboratory detection, but jaundice and hemolytsis can interfere in several tests to varying degrees.The POCT system can basically ensure accurate detection under field conditions of temperature and humidity, but should not work under extreme environments.

Evaluation of Point-of-Care Testing Devices for Pre-donation Alanine Aminotransferase Test / 대한수혈학회지

BACKGROUND: In Korea, since 1990, in an effort to reduce the transmission of non-A, non-B hepatitis, all blood donations with alanine aminotransferase (ALT) levels above 65 IU/L are discarded. In 2012, 64.8% of the disposed blood units at the Korean Red Cross blood centers were due to high ALT levels. Pre-donation ALT testing might prevent unnecessary blood donation and save related expenses. We evaluated performance of point-of-care test (POCT) devices for pre-donation ALT screening. METHODS: ALT levels by four ALT POCT devices (Mission C100, Acon; Reflotron Plus, Roche; Labgeo PT10, Samsung; and FDC NX500, Fujifilm) were compared with venous blood results using laboratory chemistry analyzers (AU series, Beckman Coulter Inc.). Intraclass correlation coefficients (ICCs), sensitivity (ability to detect ALT > or =65 IU/L), and specificity (ability to detect <65 IU/L) for each method were calculated. RESULTS: Compared with the laboratory analyzers, the ICCs of ALT measurements by Mission C-100, Reflotron Plus, Labgeo PT10, and FDC NX500 were 0.96 (95% confidence interval (CI): 0.95~0.97), 0.99 (95% CI: 0.99~0.99), 0.98 (95% CI: 0.98~0.98), and 0.94 (95% CI: 0.91~0.96), respectively. The sensitivity was 80.95% for Mission C-100, 83.33% for Reflotron Plus, 78.57% for Labgeo PT10, and 97.62% for FDC NX500. The specificity was 99.13% for Mission C-100, 100.00% for Reflotron Plus, 99.78% for Labgeo PT10, and 98.26% for FDC NX500. CONCLUSION: The ALT POCT devices showed almost perfect agreement with the laboratory analyzers and could be useful for pre-donation ALT screening. However, before implementing ALT POCT devices, cost-effectiveness analyses should be performed.

Validity of Two Point-of-Care Glucometers in the Diagnosis of Neonatal Hypoglycemia.

Objective: To estimate validity of two point-of-care glucometers for the diagnosis of neonatal hypoglycemia and to determine the glucometer’s cut-off values for which standard laboratory confirmatory test are no longer needed. Design: Prospective study. Settings: A tertiary care, university hospital in Bangkok, Thailand. Participants: The study included 180 blood specimens from 166 high-risk neonates aged between 1-24 hours. Results: On average, most of the blood glucose read-outs from the Nova StatStrip and SureStep were higher than laboratory plasma glucose throughout the glucose range with mean differences (SD) of 11.2 (8.4) mg/dL and 13.7 (6.8) mg/dL, respectively. Sensitivity of Nova StatStrip and SureStep were 62% and 53.3%, respectively. Specificity and positive predictive value of both glucometers were 100%. Negative predictive values of both glucometers were approximately 85%. The cut-off levels with 100% negative predictive values were 63 mg/dL and 62 mg/dL for Nova StatStrip and SureStep, respectively. Conclusions: None of the glucometers in this study has sufficient validity to replace laboratory testing in diagnosing hypoglycemia. Confirmatory plasma glucose for diagnosis of hypoglycemia is needed when POC readings are between 39 and 63 mg/dL for Nova StatStrip and between 39 and 62 mg/dL for SureStep.

Perioperative bleeding disorder and intraoperative ponit-of-care testing of coagulation during cardiac surgery

Cardiac surgery is frequently associated with an excessive perioperative blood loss requiring transfusion of blood products. Various point-of-care(POC) assessments for coagulation and platelet function allow an appropriate and, targeted therapy and reduce blood loss and transfusion requirements. In particular, a quick evaluation of platelet and coagulation defects with new POC devices can optimize the administration of pharmacological and transfusion-based therapy in cardiac surgery. The main advantages of POC tests are shorter time delay, assessment in whole blood and patient's temperature, potential to measure entire clotting process and to include information of platelet function. A transfusion algorithm using POC tests showed effectiveness in reducing intraoperative bleeding and transfusion requirements. Standardized procedure, strict quality control and trained personnel are highly recommended for optimal accuracy and performance of POC tests.

Usefulness of NMP22 BladderChek for the Diagnosis and Monitoring of Bladder Cancer / 대한진단검사의학회지

BACKGROUND: As bladder cancer is a superficial tumor with frequent recurrences, early detection and confirmation of recurrence are important. We evaluated the usefulness of NMP22 BladderChek (NMP22BC) for the diagnosis and monitoring of bladder cancer. METHODS: From July to December 2004, we enrolled in the study 670 patients who visited the urology clinic in Ewha Womans University, Dongdaemun Hospital with hematuria or dysuria and were tested with NMP22BC. We also performed the NMP22BC and BTA stat tests simultaneously in 21 patients and interference test in 10 patients. RESULTS: NMP22BC tests were negative in 97% of the patients who had been cured of bladder cancer and were positive in 95% of the patients with recurred bladder cancer. The diagnostic sensitivity, specificity, positive and negative predictive value, and efficiency were 95.0%, 91.5%, 25.7%, 99.8%, and 91.6%, respectively, with 8.5% false positive and 5% false negative rates. Fifty-five patients showed false positive in the NMP22BC test, the main cause of which was the presence of WBCs in urine. There was a good agreement between the NMP22BC and BTA stat tests (kappa agreement value, 0.5; P=0.008). According to the interference test, two patients with more than 3+ in leukocyte esterase results showed false positive in the NMP22BC test. CONCLUSIONS: NMP22BC test was simple to perform, rapid to produce the results, and useful in diagnosing a bladder cancer recurrence; the test shows a high efficiency with a high sensitivity, specificity, negative predictive value, and low false negative rate.

Evaluation of Gluchec Fine Glucometer / 임상검사와정도관리

BACKGROUND: We evaluated the analytical performance of the recently developed glucometer Gluchec Fine (KMH Co., Ltd., Anyang, Gyeonggi, Korea) in Korea. METHODS: Within-run precision and total precision were assessed according to CLSI guideline EP5-A2 with control material of low and high level. Linearity was evaluated in the range of 51-473 mg/dL made by patient samples. Correlations with SureStep (Lifescan, Milpitas, CA, USA) and TBA200-FR (Toshiba, Tokyo, Japan) were evaluated using 99 patient samples in the range of 23-473 mg/dL. Interferences by acetaminophen, ascorbic acid, bilirubin, cholesterol, galactose, and uric acid were elvauated according to CLSI guideline EP7-A. Effect of hematocrit, user variability and reagent stability were assessed. RESULTS: The CVs of within-run precision were 2.5-3.0% and the CVs of total precision were 3.6-4.7%. The linearity was R(2)=0.998. The correlations with TBA200-FR (R=0.982) and Surestep (R=0.984) were acceptable. Glucose concentrations measured by Gluchec Fine were lower than those by TBA200-FR (mean 2.7%, 95% CI 0.3-5.1%) in the range of 23-473 mg/dL. Acetaminophen, galactose, and cholesterol did not interfere with glucose measurements on Gluchec Fine. High concentrations of ascorbic acid, bilirubin, and uric acid resulted in positive interferences. Hematocrit and user variability did not significantly influence the glucose concentration. Reagent was stable until one week after opening. CONCLUSIONS: Gluchec Fine glucometer showed acceptable and comparable analytical performance. This instrument can be used for therapeutic monitoring of diabetes patients.

Evaluation of Urine NMP22 Point-of-Care Test for the Screening of Bladder Cancer / 대한진단검사의학회지

BACKGROUND: Screening of high-risk patients using bladder tumor markers can offer an advantage of early detection and saving medical costs. For these purpose many tumor markers have been developed to supplement invasive cystoscopy. Our study evaluated the NMP22 point-of-care test (NMP22 POCT), which is one of the tumor makers, comparing with the standard urine cytology for the diagnosis of bladder cancer. METHODS: From January to September 2005, 232 patients who had undergone a cystoscopy due to bladder cancer associated symptoms including hematuria and dysuria were enrolled in this study. Urine specimens were collected for NMP22 POCT and cytology. NMP22 POCT and urine cytology were compared for sensitivity and specificity. In addition, we evaluated urine stick test and microscopy to explain some false-positive results in NMP22 POCT. RESULTS: Superficial transitional cell carcinoma was diagnosed in 10 patients. The sensitivity of NMP22 test was 60% (95% confidence interval [CI], 26.2-87.8%), whereas that of cytology was 33.3% (95% CI, 7.5-70.1%); however, the difference was not significant. The specificity of NMP22 test was 69.8% (95% CI, 63.3-75.8%), compared with 99.0% (95% CI, 96.5-99.9%) for cytology (P<0.001). The presence of microscopic RBCs in urine specimen was significantly associated with the lower specificity of NMP22 POCT (P=0.02). CONCLUSIONS: NMP22 POCT was significantly less specific than urine cytology. To be useful as a bladder cancer screening test, the NMP22 test should have a higher specificity.

Evaluation of i-STAT(TM) Portable Clinical Analyzer in a Neonatal Intensive Care Units / 대한주산의학회잡지

OBJECTIVES: OCT(Point-of-Care Test), often translated as "Bedside laboratory", is a testing method used in most developed countries to conduct medical research. It is known to extract rapid results that can be applied in the intensive care unit. This study was conducted to investigate the correlation of the i-STAT(TM) POCT analyzer with the traditional test in the neonatal intensive care units. METHODS: 60 babies(birth weight > or =1.0kg) who were admitted to neonatal intensive care unit from June, 2000 to June, 2001 at Asan Medical Center requiring blood samples for the testing of arterial blood gas analysis(ABGA), electrolytes, hemoglobin(Hb), hematocrit(Hct), were included in the study. Blood samples were taken simultaneously to be tested by the traditional laboratory method and by i-STAT(TM) (i-STAT Co. USA) POCT analyzer. The data used for comparison analyzation included pH, pCO2, pO2, HCO3, Na, K, Hb, and Hct. RESULTS: 245 measurements of ABGA and 195 measurements of Na, K, Hb, Hct from 60 babies were used for comparison. Good correlation of data was found between i-STAT(TM) POCT analyzer and traditional laboratory method obtained from the central laboratory(correlation coefficient: pH 0.954, pCO2 0.944, pO2 0.941, HCO3 0.880, Na 0.713, K 0.860, Hb 0.864, Hct 0.880). CONCLUSION: This study showed that i-STAT(TM) POCT analyzer provided accurate analytic results when compared with traditional laboratory method used in the neonatal intensive care units.