Customer satisfaction survey with clinical laboratory and phlebotomy services at a tertiary care unit level.

We performed customer satisfaction surveys for physicians and nurses regarding clinical laboratory services, and for outpatients who used phlebotomy services at a tertiary care unit level to evaluate our clinical laboratory and phlebotomy services. Thus, we wish to share our experiences with the customer satisfaction survey for clinical laboratory and phlebotomy services. Board members of our laboratory designed a study procedure and study population, and developed two types of questionnaire. A satisfaction survey for clinical laboratory services was conducted with 370 physicians and 125 nurses by using an online or paper questionnaire. The satisfaction survey for phlebotomy services was performed with 347 outpatients who received phlebotomy services by using computer-aided interviews. Mean satisfaction scores of physicians and nurses was 58.1, while outpatients' satisfaction score was 70.5. We identified several dissatisfactions with our clinical laboratory and phlebotomy services. First, physicians and nurses were most dissatisfied with the specimen collection and delivery process. Second, physicians and nurses were dissatisfied with phlebotomy services. Third, molecular genetic and cytogenetic tests were found more expensive than other tests. This study is significant in that it describes the first reference survey that offers a survey procedure and questionnaire to assess customer satisfaction with clinical laboratory and phlebotomy services at a tertiary care unit level.

Elecsys hepatitis B surface antigen quantitative assay: performance evaluation and correlation with hepatitis B virus DNA during 96 weeks of follow-up in chronic hepatitis B patients.

BACKGROUND: Treatment for chronic hepatitis B aims to suppress virus replication and virus sequestration in hepatocytes. Covalently closed circular (ccc) DNA is the template for transcription of viral genes and is responsible for viral persistence. However, limited data are available for quantification of hepatitis B surface antigen (HBsAg) in Korea. METHODS: We evaluated the Elecsys HBsAg II quant assay (Roche Diagnostics, USA) for within-run, between-run, and between-day precisions, linearity, carryover, and clinical specificity. In total, 156 serum samples were evaluated for correlation between HBsAg and hepatitis B virus (HBV) DNA. Serial samples were obtained from 10 patients at 0, 12, 24, 48, 72, and 96 weeks during follow-up. RESULTS: The assay detected HBsAg in a linear range of 0.5-48,696 IU/mL. Within-run, between-run, and between-day CVs were 2.9-4.1%, 0-1.5%, and 1.5-4.9%, respectively. Cross-reactivity between potentially interfering substances was absent, and the carryover rate was 0.00002%. The correlation of measurements between the Elecsys assay and HBV DNA PCR was weak (r=0.438, P=0.002). For predicting virologic response, cutoff values of 10,275 IU/mL and 3,846 IU/mL at 12 and 24 weeks after treatment initiation showed positive predictive values of 77.1% and 85% and negative predictive values of 84.6% and 50%, respectively. CONCLUSIONS: The Elecsys HBsAg II quant assay showed good performance for precision, linearity, carryover rate, and specificity. HBsAg level at baseline, 12 weeks, and 24 weeks after treatment initiation can predict virologic response, and the assay can be used for HBsAg quantification in clinical practice.

Evaluation of recombinant factor VIIa treatment for massive hemorrhage in patients with multiple traumas.

BACKGROUND: Recent studies and case reports have shown that recombinant factor VIIa (rFVIIa) treatment is effective for reversing coagulopathy and reducing blood transfusion requirements in trauma patients with life-threatening hemorrhage. The purpose of this study is to evaluate the effect of rFVIIa treatment on clinical outcomes and cost effectiveness in trauma patients. METHODS: Between January 2007 and December 2010, we reviewed the medical records of patients who were treated with rFVIIa (N=18) or without rFVIIa (N=36) for life-threatening hemorrhage due to multiple traumas at the Emergency Department of Pusan National University Hospital in Busan, Korea. We reviewed patient demographics, baseline characteristics, initial vital signs, laboratory test results, and number of units transfused, and then analyzed clinical outcomes and 24-hr and 30-day mortality rates. Thromboembolic events were monitored in all patients. Transfusion costs and hospital stay costs were also calculated. RESULTS: In the rFVIIa-treated group, laboratory test results and clinical outcomes improved, and the 24-hr mortality rate decreased compared to that in the untreated group; however, 30-day mortality rate did not differ between the groups. Thromboembolic events did not occur in both groups. Transfusion and hospital stay costs in the rFVIIa-treated group were cost effective; however, total treatment costs, including the cost of rFVIIa, were not cost effective. CONCLUSIONS: In our study, rFVIIa treatment was shown to be helpful as a supplementary drug to improve clinical outcomes and reduce the 24-hr mortality rate, transfusion and hospital stay costs, and transfusion requirements in trauma patients with life-threatening hemorrhage.

Thrombotic thrombocytopenic purpura triggered by influenza A virus subtype H1N1 infection.

We report a case of acquired thrombotic thrombocytopenic purpura (TTP) triggered by influenza A virus subtype H1N1 infection. In December 2010, a 27-year-old man was diagnosed with pneumonia from influenza A virus infection at a local clinic. Two days later, he was admitted to our hospital because of a worsening condition and unexplained thrombocytopenia. The influenza A virus subtype H1N1 real-time polymerase chain reaction test was positive. The patient had typical clinical signs of TTP, thus he was diagnosed with TTP. He received treatment with oseltamivir and high dose methylprednisolone. Plasma exchange therapy was started daily at a 1.5 dose volume of his whole blood. After the 17th plasma exchange therapy, the symptoms and abnormal laboratory results had recovered to normal. Finally, 47 days after admission, the patient had recovered completely and was discharged. This case suggests that the influenza A virus subtype H1N1 infection may have triggered acquired TTP.

[Evaluation of ARCHITECT HCV core antigen assay].

BACKGROUND: Hepatitis C virus (HCV) core antigen (Ag) levels are known to be well correlating with HCV RNA levels, and may be used as an alternative marker of HCV replication for monitoring the response to HCV treatment. However, the low sensitivity of HCV core Ag assay has been an obstacle for clinical use. In this study, recently developed ARCHITECT HCV Ag assay (Abbott Laboratories, USA) was evaluated for analytical performance and clinical usefulness. METHODS: A total of 109 sera from HCV infected patients including various genotypes of HCV (1b, 2, 2a/2c, 2b, and 3a) and 20 sera from healthy donors were used for evaluating the sensitivity, precision, and linearity of the HCV core Ag assay. The cross reactivity with HIV, hepatitis B virus and myeloma proteins (N=5, each) and correlation with HCV RNA PCR assay were also evaluated. RESULTS: The sensitivity of the HCV core Ag assay was 97.2% (106/109) and there were no false positive results and cross reactivity. The within-run, between-run and between-day CVs were 3.0%, 2.5% and 3.0%, respectively. The levels of HCV core antigen showed a good correlation with those of HCV RNA quantification (r=0.940). The HCV Ag assay showed an excellent linearity in the range from 0.63 to 17,114 fmol/L (r=0.999). CONCLUSIONS: The ARCHITECT HCV Ag assay was good in sensitivity, precision, and linearity and its results well correlated with HCV RNA levels. This assay could be used as a good marker of viral replication for monitoring the therapy response in chronically HCV infected patients.

[Comparison of the frequencies and distributions of unexpected antibodies based on different calculation criteria].

BACKGROUND: The frequencies and distributions of unexpected antibodies have been reported using two different criteria, based on either number of persons tested or number of tests performed. But there has been no study that compared the results of analyses based on these two different criteria using the same data set. METHODS: Unexpected antibody tests performed in a University Hospital during recent 6 yr (January 2002-December 2007) were retrospectively analyzed: 76,985 tests (59,503 persons) for screening and 875 tests (749 persons) for identification. Data were analyzed using two different criteria, based on 'persons tested' and 'tests performed'. Antibodies had been screened and identified using LISS/Coombs gel cards with DiaMed-ID system (DiaMed AG, Switzerland). RESULTS: Frequencies of unexpected antibodies based on 'persons tested' and 'tests performed' were 1.32% and 1.34%, respectively (P=0.88). For frequently detected as well as rarely detected antibodies, there were no significant differences in the frequencies based on two different criteria. However, for rarely detected antibodies (anti-Xg(a) and Anti-E & D), the frequencies based on 'tests performed' were higher than those based on 'persons tested', affecting a change in the order of frequencies of antibodies detected. CONCLUSIONS: As there were no significant differences in the frequencies of unexpected antibodies calculated using two different criteria, both criteria can be used together for the patient population in our hospital. However, two criteria should be compared to validate the results for other populations.

[Meta-analysis for the pooled sensitivity and specificity of hepatitis B surface antigen rapid tests].

BACKGROUND: Although hepatitis B surface antigen (HBsAg) rapid test based on immunochromatographic assay (ICA) is now widely used, the test has not been evaluated sufficiently enough to validate its performance. Thus, it is important to summarize the clinical performance of the test kits. In this study, we performed meta-analysis for the performance of the HBsAg rapid tests. METHODS: PubMed database was searched using keywords about the accuracy of diagnostic tests for hepatitis B virus (HBV) infection. Two investigators assessed methodological quality utilizing standards for reporting of diagnostic accuracy studies (STARD) checklist. After performing a heterogeneity test, we obtained pooled sensitivity and specificity. Positive and negative predictive values (PPV and NPV) were simulated according to HBV prevalence. RESULTS: A total of 38 studies was selected from 10 papers. The quality scores ranged from 3 to 13 (median, 8). Kappa value was good (0.85). The performance of the 38 studies was heterogeneous. When 33 studies with better quality from 7 papers were re-selected, the pooled sensitivity and specificity were 98.07% (95% confidence interval, CI: 97.67-98.47%) and 99.56% (95% CI: 99.21-99.91%), respectively. With an HBV prevalence of 5%, PPV and NPV were predicted to be 92.14% and 99.90%, respectively. CONCLUSIONS: In view of high HBV prevalence in Korea, it is thought that the HBsAg rapid test can be used for HBV screening in small-sized laboratories or for epidemiologic studies. This study should be helpful in establishing a guideline for the proper performance evaluation of the HBsAg rapid tests.

Partial trisomy 1q41 syndrome delineated by whole genomic array comparative genome hybridization.

Partial trisomy 1q syndrome is a rare chromosomal abnormality. We report on a male infant with 46,XY,der(11)t(1;11)(q41;p15.5) due to unbalanced segregation of the maternal reciprocal balanced translocation 46,XX,t(1;11)(q41;p15.5). The baby presented with a mild phenotype, characterized by a triangular face, almond-shaped eyes, low ears, short stature with relatively long legs, and mild psychomotor retardation. We utilized whole genomic array comparative genome hybridization (CGH) with 4,000 selected bacterial artificial chromosomes (BACs) to define the chromosomal breakpoints and to delineate the extent of the partial trisomy in more detail. To our knowledge, this is the first case of nearly pure "partial trisomy 1q41" defined by whole genomic array CGH.

Evaluation of the Sysmex UF-100 urine cell analyzer as a screening test to reduce the need for urine cultures for community-acquired urinary tract infection.

We evaluated the UF-100 flow cytometer (TOA Medical Electronics, Kobe, Japan) as a screening test for community-acquired urinary tract infection (UTI) to reduce the need for bacterial cultures. By comparing the test results for 330 urine samples with quantitative urine cultures, we established cutoff criteria for the UF-100. To rule out hospital-acquired UTI, all urine samples were from new patients who had not been admitted to a hospital within the previous month. Abacterial cutoff value of 3,000/microL provided the best discrimination for community-acquired UTI, with a sensitivity of 94.4% and a specificity of 73.4%compared with urine culture. It was possible to forgo 58.2% of cultures with only 4 false-negative results. With a bacterial cutoff value of 1,500/microL, the sensitivity improved to 100%, but the specificity declined to 49.8%, and only 38.5% of cultures could be avoided without any false-negative results. Screening with the UF-100 for community-acquired UTI is acceptable for routine use. It would improve the efficiency of the routine microbiology laboratory, and unnecessary antibiotic prescriptions could be reduced.

[Diagnostic Usefulness of SD Malaria Antigen and Antibody Kits for Differential Diagnosis of vivax Malaria in Patients with Fever of Unknown Origin.].

BACKGROUND: Examination of peripheral blood smear (PBS) is the gold standard for the diagnosis of malaria; however, its diagnostic utility will be dependent on the examiner's microscopic experience, the quality of the smear, and the degree of parasitemia. Therefore, it is essential to have available a rapid and simple test that is as sensitive and specific as PBS, at a small-middle range medical center, a health care center, and a military hospital in a malaria endemic area. METHODS: Malaria antigen and antibody tests were performed on 120 febrile patients who were requested for complete blood count (CBC) and PBS at two military hospitals from May 2004 to August 2005. RESULTS: Of the 45 patients who were diagnosed with malaria by examination of peripheral blood smears, 42 were positive on both malaria antigen and antibody tests, and 2 were positive on either antigen or antibody test. Only 1 patient was negative on the both test. Furthermore, all 75 patients with negative microscopic examinations also had negative malaria antigen and antibody tests. CONCLUSIONS: The results of this study show that a rapid differential diagnosis of malaria can be made by performing malaria antigen and antibody tests on febrile patients at hospitals in malaria endemic areas. Moreover, the test is simple and convenient enough to be performed without any special equipment or experience.

Changes in plasma ghrelin concentration immediately after gastrectomy in patients with early gastric cancer.

Although the majority of circulating ghrelin originates from the stomach, no prospective study of the proportion of ghrelin derived from the stomach has been reported. Patients with early gastric cancer who underwent gastric resection were divided into three groups according to the extent and site of gastric resection: subtotal gastrectomy group (n = 24), proximal gastrectomy group (n = 4), and total gastrectomy group (n = 12). Patients with advanced gastric cancer who underwent gastrojejunostomy without gastrectomy served as the bypass group (n = 5). Blood samples were collected from all patients preoperatively, at 1 h after gastric resection or gastrojejunostomy, and on postoperative d 1, 3, and 7. The plasma ghrelin level was determined in all samples and expressed as a percentage of the preoperative level. In the bypass group, no significant drop in the ghrelin level was observed at 1 h after gastrojejunostomy, and the ghrelin level remained stable through postoperative d 7. In the subtotal gastrectomy group, the ghrelin concentration reached a nadir of 38.8 +/- 12.9% of preoperative levels at 1 h after gastric resection and then gradually increased to 88.1 +/- 13.2% by postoperative d 7. In the proximal gastrectomy group, the nadir ghrelin level was 24.5 +/- 15.4% at 1 h after gastric resection and was followed by a gradual recovery. However, the recovery rate was slower than that in the subtotal gastrectomy group, with the ghrelin level reaching only 47.6 +/- 18.8% by postoperative d 7 (P < 0.05). In the total gastrectomy group, the nadir ghrelin level was 28.6 +/- 11.1% at 1 h after gastric resection and remained at 30.0 +/- 13.2% until postoperative d 7. These results suggest that compensatory ghrelin production can occur in the remnant stomach after the surgical removal of part of the stomach and that the proximal fundus is more important than the distal antrum and body in terms of the capacity for ghrelin production. The principal site of ghrelin production is clearly the stomach, which contributes 70% of the circulating ghrelin concentration.

Acute hemolytic transfusion reactions due to multiple alloantibodies including anti-E, anti-c and anti-Jkb.

We report a case of two consecutive episodes of acute hemolytic transfusion reactions (HTRs) due to multiple alloantibodies in a 34-yr-old man who suffered from avascular necrosis of left femoral head. He received five units of packed red blood cells (RBCs) during surgery. Then the transfusion of packed RBCs was required nine days after the surgery because of the unexplained drop in hemoglobin level. The transfusion of the first two units resulted in fever and brown-colored urine, but he received the transfusion of another packed RBCs the next day. He experienced even more severe symptoms during the transfusion of the first unit. We performed antibody screening test, and it showed positive results. Multiple alloantibodies including anti-E, anti-c and anti-Jkb were detected by antibody identification study. Acute HTRs due to multiple alloantibodies were diagnosed, and the supportive cares were done for 6 days. We suggest the antibody screening test should be included in the panel of pretransfusion tests for safer transfusion, and it is particularly mandatory for the patients with multiple transfusions, pregnant women, and preoperative patients.

The clinical significance of antibody screening test including Dia+ panel cell in Asian-Mongoloid populations.

The Di(a) antigen is well known as one of the antigens with low incidence among Caucasians; however, it has been discovered with a relatively higher incidence among Mongoloid populations. Thus, it has been speculated that the incidence of unexpected antibody against the Di(a) antigen might be relatively higher among these populations. Hemolytic transfusion reactions (HTRs) and hemolytic disease of the newborns (HDNs) caused by anti-Di(a) have been reported sporadically. However, there has been no prospective study on the incidence of anti-Di(a) in Mongoloid populations particularly. The authors conducted a series of antibody screening tests on 11,219 Korean individuals for 25 months, by using three kinds of screening cells including Di(a) cell. Anti-Di(a) was detected in 8 patients, seven of whom had a history of transfusions or were multigravida. The incidence of anti-Di(a) measured in this study was higher than expected, ranked third among unexpected antibodies identified during the period of the study, so it is strongly recommended that the Di(a+) panel cell must be incorporated into antibody screening test for safer transfusion in Asian-Mongoloid populations.

Plasmodium vivax malaria complicated by hemophagocytic syndrome in an immunocompetent serviceman.

We describe a 23-year-old retired military officer who was immunocompetent but diagnosed with hemophagocytic syndrome (HPS) by Plasmodium vivax infection. Initially, the patient was suspected to have toxic hepatitis related to heavy drinking. But abnormal hematologic findings required a further bone marrow examination and the diagnosis of HPS was made. Antimalarial chemotherapy then brought complete remission. Plasmodium falciparum, a species causing more severe malarial infection, was listed as one of the major causes of HPS. However, P. vivax was not mentioned, and only one case was reported in the literature. In this study, we suggest that P. vivax malaria should be included in the differential diagnosis of HPS, even in an immunocompetent person.

Tetraploid acute promyelocytic leukemia with double t(15;17) and PML/RARA rearrangements detected by fluorescence in situ hybridization analysis.

Acute promyelocytic leukemia (APL) is characterized by a serious hemorrhagic syndrome, unique morphologic findings, and its response to retinoids. Tetraploidy is a very rare chromosomal abnormality in acute myelocytic leukemia. This report presents a unique case of APL with a tetraploid clone characterized by two t(15;17) without other chromosomal changes, as well as PML/RARA rearrangements confirmed fluorescence in situ hybridization. The morphology of the blast cells was that of the classic M3 subtype, but the mean blast size exceeded that of control APL cases with diploidy. A chromosomal study revealed a 92,XXXX,t(15;17)(q22;q21)x2 karyotype in all 20 metaphase spreads. Despite all-trans-retinoic acid (ATRA) treatment and chemotherapy, leukemic cells persisted in the blood, and the patient died of an intracranial hemorrhage on the 16th day after admission.

Reduction of contamination of mycobacterial growth indicator tubes with a modified antimicrobial combination.

Culture in the fluorimetric Mycobacteria Growth Indicator Tube (MGIT) treated with a combination of vancomycin, amphotericin B, and nalidixic acid (VAN) showed growth of most strains of 31 mycobacterial species with a less-than-1-day delay. The results were similar to those in the MGIT with polymyxin B, amphotericin B, nalidixic acid, trimethoprim, and azlocillin, but with respiratory specimens, the MGIT with VAN showed a lower contamination rate with no change in the detection rate or time.

Type-specific antibody for hepatitis C virus detected by use of NS-4 peptide and hepatitis C virus genome in Korea.

Hepatitis C virus, often possessing mutant genes, have the features that allow them to avoid host's immunologic response and further cause chronic progressive infections. Therefore, it is essential for those patients infected of HCV to receive improved diagnostic procedures. And it is equally important to investigate the course of disease progression and the response to treatment. The goal of this study is to review the efficacy of the third generation immunoblot assay and standardized RT-PCR-Hybridization assay, and in contrast with genotype identification(genotyping), the followings were briefly evaluated for the efficacy of serotype identification(serotyping) by using NS-4 peptide in the observation of the course and in the treatment of patients with HCV hepatitis. 1. The true positive rate in 132 cases showing repeated positives with 3rd generation anti-HCV EIA are 81.8% by immunoblot assay and 75.8% by RT-PCR-Hybridization assay. 2. The 79.5% concordance of immunoblot and RT-PCR-Hybridization assay is shown. The negative results from immunoblot assay are also negative in RT-PCR-Hybridization assay. 3. Among 95 patients with HCV hepatitis patients in 95 cases, the serotype 1, 2 and 4 were 53.2%, 45.2%, and 1.6%, respectively. In 29 cases, the genotypes of patients with HCV showed 1b in 15 cases, 2a/2c in 8 cases, 2b in 2 cases and mixed type in 4 cases. 4. In comparison between serotype and genotype, they showed 75.9% concordance. But serotyping showed higher efficacy in experimental procedures and sampling conditions, with more convenience. Based on above evaluation and reference review, it is reasonable to check with 3rd generation immunoblot assay the samples producing repeated positive results from anti-HCV EIA. For more definitive diagnosis of HCV infection, it is appropriate to confirm and double-check with standardized RT-PCR-Hybridization assay. Lastly, it is strongly suggested that for observation of progression and for choice of interferon treatment, serotype identification(serotyping) is more useful in practice than genotype identification (genotyping).