Feasibility of Using Needle Rinse Fluid for Cobas Human Papillomavirus (HPV) Assay in Diagnosing HPV+ Oropharyngeal Cancer with Neck Lymph Node Aspiration.

BACKGROUND: Human papillomavirus (HPV) is a crucial prognostic factor in oropharyngeal cancer (OPC). p16 is a surrogate marker for diagnosing HPV+ OPC, however it is not direct evidence of HPV existence. OBJECTIVE: The purpose of our study was to evaluate an HPV DNA test-Cobas HPV assay-in diagnosing HPV+ OPC through neck lymph node aspiration. METHODS: Patients with suspected neck mass who received fine needle aspiration (FNA) or core needle biopsy (CNB) at the National Taiwan University Hospital between January 2018 and December 2022 were reviewed. Besides routine cytology and pathology study, needle rinse fluid was collected for the Cobas HPV assay to detect high-risk HPV. RESULTS: We analyzed 137 patients with suspected lymph nodes, 32 (23.4%) of whom were HPV+ OPC patients and 105 (76.6%) of whom had non-HPV-related disease. FNA was performed in 31 patients and CNB was performed in 106 patients, according to the size and necrosis status of the lymph nodes. For diagnosing HPV+ OPC, CNB combined with p16 immunohistochemistry staining showed sensitivity of 93.3%, specificity of 97.8%, positive predictive value (PPV) of 87.5%, negative predictive value (NPV) of 98.9%, and accuracy of 97.2%. On the other hand, for the needle rinse Roche Cobas HPV assay, the test showed sensitivity of 96.9%, specificity of 100%, PPV of 100%, NPV of 99.1%, and accuracy of 99.3%. Compared with p16 IHC staining, the Cobas HPV test showed better PPV with statistical significance (p = 0.04). CONCLUSION: The Cobas HPV assay is a US FDA-approved, highly automated, and readily used technique to directly detect the presence of high-risk HPV. We recommend utilizing the Cobas HPV assay in combination with routine cytology or histopathology examination in the work-up of neck lymphadenopathy.

Environment contamination and intra-hospital spread of COVID-19 in a tertiary care Hospital in Taiwan.

BACKGROUND: The role of environmental contamination in COVID-19 transmission within hospitals is still of interest due to the significant impact of outbreaks globally. However, there is a scarcity of data regarding the utilization of environmental sampling for informing infection control measures during SARS-CoV-2 outbreaks. METHODS: This retrospective study analyzed incident event investigations conducted at a single center from May 1, 2021, to August 31, 2021. Investigations were initiated following the identification of a COVID-19 confirmed case (referred to as the index case) who had stayed in a hospital area outside the dedicated COVID-19 ward/bed and without specific COVID-19 precautions. Measures to prevent intra-hospital spread included contact tracing, adjusted testing policies, isolation of confirmed cases, quarantine of close contacts, environmental disinfection, and PCR testing of environmental samples. RESULTS: Among the 18 incident events investigated, the index case was a healthcare personnel in 8 events, a patient in 8 events, and a caregiver in 2 events. The median number of confirmed COVID-19 cases within 14 days was 13 (IQR, 7-31) for events with SARS-CoV-2 RNA detected on environmental surfaces, compared to only one (IQR, 1-1.5) for events without surface contamination (P = 0.04). Environmental contamination was independently associated with a higher number of COVID-19 cases (P < 0.001). CONCLUSION: This study highlights environmental contamination as an indicator of the severity of incident events and provides a framework for incident event management, including a protocol for environmental sampling. Implementing these measures can help prevent the spread of COVID-19 within healthcare facilities.

Evolution of neutralizing antibodies and cross-activity against different variants of SARS-CoV-2 in patients recovering from COVID-19.

BACKGROUND: Patients recovering from COVID-19 may need vaccination against SARS-CoV-2 because acquired immunity from primary infection may wane, given the emergence of new SARS-CoV-2 variants. Understanding the trends of anti-spike IgG and neutralizing antibody titers in patients recovering from COVID-19 may inform the decision made on the appropriate interval between recovery and vaccination. METHODS: Participants aged 20 years or older and diagnosed with COVID-19 between January and December, 2020 were enrolled. Serum specimens were collected every three months from 10 days to 12 months after the onset of symptom for determinations of anti-spike IgG and neutralizing antibody titers against SARS-CoV-2 Wuhan strain with D614G mutation, alpha, gamma and delta variants. RESULTS: Of 19 participants, we found a decreasing trend of geometric mean titers of anti-spike IgG from 560.9 to 217 and 92 BAU/mL after a 4-month and a 7-month follow-up, respectively. The anti-spike IgG titers declined more quickly in the ten participants with severe or critical disease than the nine participants with only mild to moderate disease between one month and seven months after SARS-CoV-2 infection (-8.49 vs - 2.34-fold, p < 0.001). The neutralizing activity of the convalescent serum specimens collected from participants recovering from wild-type SARS-CoV-2 infection against different variants was lower, especially against the delta variants (p < 0.01 for each variant with Wuhan strain as reference). CONCLUSION: Acquired immunity from primary infection with SARS-CoV-2 waned within 4-7 months in COVID-19 patients, and neutralizing cross-activities against different SARS-CoV-2 variants were lower compared with those against wild-type strain.

Viral dynamics of SARS-CoV-2 Omicron infections in a previously low COVID-19 prevalence region: Effects of vaccination status, antiviral agents, and age.

BACKGROUND: In Taiwan, the prevalence of COVID-19 was low before April 2022. The low SARS-CoV-2 seroprevalence in the population of Taiwan provides an opportunity for comparison with fewer confounding factors than other populations globally. Cycle threshold (Ct) value is an easily accessible method for modeling SARS-CoV-2 dynamics. In this study, we used clinical samples collected from hospitalized patients to explore the Ct value dynamics of the Omicron variant infection. METHODS: From Jan 2022 to May 2022, we retrospectively included hospitalized patients tested positive by nasopharyngeal SARS-CoV-2 PCR. We categorized the test-positive subjects into different groups according to age, vaccination status, and use of antiviral agents. To investigate the nonlinear relationship between symptom onset days and Ct value, a fractional polynomial model was applied to draw a regression line. RESULTS: We collected 1718 SARS-CoV-2 viral samples from 812 individuals. The Ct values of unvaccinated individuals were lower than those of vaccinated persons from Day 4 to Day 10 after symptom onset. The Ct value increased more rapidly in those individuals with antiviral drug treatment from Day 2 to Day 7. In elderly individuals, the Ct values increased slowly from Day 5 to Day 10, and the increasing trend was unique compared with that in children and adults. CONCLUSION: Our study demonstrated the primary viral infection dynamics of the Omicron variant in hospitalized patients. Vaccination significantly affected viral dynamics, and antiviral agents modified viral dynamics irrespective of vaccination status. In elderly individuals, viral clearance is slower than that in adults and children.

Hepatitis E Virus Infections Among Human Immunodeficiency Virus-Positive Individuals During an Outbreak of Acute Hepatitis A in Taiwan.

Hepatitis A virus (HAV) and hepatitis E virus (HEV) share the similar fecal-oral transmission route. During an outbreak of sexually transmitted acute hepatitis A among men who have sex with men (MSM) worldwide between 2015 and 2017, we investigated the possibility of sexual transmission and related morbidity of HEV infection among human immunodeficiency virus (HIV)-positive patients. From March 1, 2015 to August 31, 2017, anti-HEV immunoglobulin G was retrospectively determined among 3,293 HIV-positive patients, who were mainly MSM (87.6%) with a median CD4 count of 575 cells/µL. Prevalence and incidence of HEV infection were 3.7% (123 of 3,293) and 4.35 per 1,000 person-years of follow-up (PYFU), respectively, which were significantly lower compared with those of HAV infection (31.1% [996 of 3,204] and 12.61 per 1,000 PYFU, respectively). The number of patients with HEV infection did not increase with the hepatitis A epidemic. The factor associated with prevalent HEV infection was older age (per 1-year increase, adjusted odds ratio, 1.07; 95% confidence interval, 1.05-1.09), but neither sexual orientation nor acquisition of sexually transmitted infections was related to prevalent or incident HEV infection. Among 23 patients with incident HEV infection, 22 patients had viremia caused by HEV genotype 4. No patients had prolonged HEV viremia or clinical symptoms, and only a mild elevation of serum aminotransferase, ranging from 34 to 77 IU/L, was noted. Although 4 patients had hepatitis for a prolonged duration of between 8 and 17 months, no abdominal imaging revealed liver fibrosis or cirrhosis. Conclusion: HEV endemicity remained low among HIV-positive patients in Taiwan during the outbreak of acute hepatitis A. Our data suggest that sexual transmission of HEV with significant morbidity of HEV infection, if any, is rare in this population.

Virological, serological, and antiviral studies in an imported human case of avian influenza A(H7N9) virus in Taiwan.

We describe the clinical course and virological characteristics of the first H7N9 influenza case in a Taiwanese patient; this patient had detectable viruses in the airway for 2 weeks, during which time an oseltamivir resistance-associated R292K mutation rapidly emerged. Anti-H7N9 antibody was detected 21 days after onset of symptoms, when H7N9 viral load declined significantly.

Clinical manifestations and viral kinetics of people with Mpox: A case series during the 2023 outbreak in Taiwan.

Monkeypox (Mpox) has emerged as a global threat since 2022. We reported 14 cases of Mpox in 10 people with HIV (PWH) and 4 people without HIV (PWoH), of whom 64.3% had sexually transmitted co-infections. Severe complications of Mpox and prolonged viral shedding might occur in both PWH and PWoH.

Clinical assessment of SARS-CoV-2 infectivity by rapid antigen test compared with virus isolation.

Although real-time reverse transcriptase polymerase chain reaction (real-time RT-PCR) remains as a golden standard for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, it can not be easily expanded to large-scaled screening during outbreaks, and the positive results do not necessarily correlate with infectious status of the identified subjects. In this study, the performance of Vstrip® RV2 COVID-19 Antigen Rapid Test (RAT) and its correlation with virus infectivity was examined by virus culture using 163 sequential respiratory specimens collected from 26 SARS-CoV-2 infected patients. When the presence of cytopathic effects (CPE) in cell culture was used as a reference method for virus infectivity, the sensitivity, specificity and accuracy of Vstrip® RV2 COVID-19 Antigen Rapid Test was 96.43%, 89.63%, and 90.8%, respectively. The highest Ct value was 27.7 for RdRp gene and 25.79 for E gene within CPE-positive samples, and the highest Ct value was 31.9 for RdRp gene and 29.1 for E gene within RAT positive samples. When the Ct values of specimens were below 25, the CPE and RAT results had high degree of consistency. We concluded that the RAT could be a great alternative method for determining the infectious potential of individuals with high viral load.

Risky sexual practices and hepatitis C viremia among HIV-positive men who have sex with men in Taiwan.

BACKGROUND: Understanding the risk behaviors associated with sexually-transmitted hepatitis C virus (HCV) infection among men who have sex with men (MSM) may inform the public health policies and interventions aiming to achieve HCV microelimination. METHODS: HIV-positive MSM who had one of the following conditions were enrolled to undergo face-to-face questionnaire interviews to collect information on their sexual practices in the past 12 months: (1) elevation of aminotransferases in the past 6 months; (2) acquisition of sexually transmitted infections in the past 6 months; and (3) previous HCV infections. Plasma HCV RNA were tested at enrolment and every 3 months during follow-up. Baseline characteristics and risky behaviors were compared to identify factors associated with HCV viremia between HCV-viremic MSM and HCV-aviremic MSM in multivariate analysis. RESULTS: Among 781 MSM with a median age of 36 years, 57 (7.3%) had HCV viremia and 724 (92.7%) no HCV viremia during follow-up. A high proportion (38.9%) of the participants reported having used recreational drugs in the past 12 months, with 34.4% of them having slamming, but only 4.8% reported having shared their injection equipment. In multivariate analysis, use of recreational drugs (adjusted odds ratio [aOR], 2.14; 95% CI, 1.16-3.96), having participated in group sex (aOR, 2.35; 95% CI 1.24-4.40) and having had condomless receptive anal intercourse (aOR, 1.97; 95% CI 1.07-3.62) were significantly associated with HCV viremia. CONCLUSION: Among high-risk HIV-positive MSM, use of recreational drugs and risky sexual contacts were associated with HCV viremia, suggesting the mucosal contacts as the major route of HCV transmission.

Hepatitis C microelimination among people living with HIV in Taiwan.

To reach the WHO target of hepatitis C virus (HCV) elimination by 2025, Taiwan started to implement free-of-charge direct-acting antiviral (DAA) treatment programme in 2017. Evaluating the progress of HCV microelimination among people living with HIV (PLWH) is a critical step to identify the barriers to HCV elimination. PLWH seeking care at a major hospital designated for HIV care in Taiwan between January 2011 and December 2021 were retrospectively included. For PLWH with HCV-seropositive or HCV seroconversion during the study period, serial HCV RNA testing was performed using archived samples to confirm the presence of HCV viremia and estimate the prevalence and incidence of HCV viremia. Overall, 4199 PLWH contributed to a total of 27,258.75 person-years of follow-up (PYFU). With the reimbursement of DAAs and improvement of access to treatments, the prevalence of HCV viremia has declined from its peak of 6.21% (95% CI, 5.39-7.12%) in 2018 to 2.09% (95% CI, 1.60-2.77%) in 2021 (decline by 66.4% [95% CI, 55.4-74.7%]); the incidence has declined from 25.94 per 1000 PYFU (95% CI, 20.44-32.47) in 2019 to 12.15% per 1000 PYFU (95% CI, 8.14-17.44) (decline by 53.2% [95% CI, 27.3-70.6%]). However, the proportion of HCV reinfections continued to increase and accounted for 82.8% of incident HCV infections in 2021. We observed significant declines of HCV viremia among PLWH with the expansion of the DAA treatment programme in Taiwan. Further improvement of the access to DAA retreatments is warranted to achieve the goal of HCV microelimination.

Three-Stage Pooled Plasma Hepatitis C Virus RNA Testing for the Identification of Acute HCV Infections in At-Risk Populations.

Timely diagnosis and treatment of hepatitis C virus (HCV) infection may prevent its transmission. We evaluated the performance and cost reductions of the pooled plasma HCV RNA testing strategy to identify acute HCV infections among people living with HIV (PLWH). PLWH with sexually transmitted infections, elevated aminotransferases within the past 6 months or past HCV infections (high-risk) and those without (low-risk) were enrolled prospectively. Participants underwent three-stage pooled plasma HCV RNA testing every 12 to 24 weeks until detection of HCV RNA or completion of a 48-week follow-up. The three-stage strategy combined 20 individual specimens into a stage 1 pool, 5 individual specimens from the stage 1 pool that tested positive for HCV RNA in the stage 2 mini-pool, followed by testing of individual specimens of the stage 2 mini-pool tested positive for HCV RNA. A simulation was constructed to investigate the cost reductions and pooled sensitivity and specificity under different combinations of HCV prevalence and pool/mini-pool sizes. Between June 25, 2019 and March 31, 2021, 32 cases of incident HCV viremia were identified in 760 high-risk PLWH that were enrolled 834 times, giving an incidence rate of 56.6 per 1000 person-years of follow-up (PYFU). No cases of HCV viremia were identified in 557 low-risk PLWH during a total of 269.2 PYFU. Simulation analysis suggested that this strategy could reduce HCV RNA testing cost by 50% to 86% with HCV viremia prevalence of 1% to 5% and various pooled sizes despite compromised pooled sensitivity. This pooled plasma HCV RNA testing strategy is cost-saving to identify acute HCV infections in high-risk populations with HCV viremia prevalence of 1% to 5%. IMPORTANCE Our three-stage pooled plasma HCV RNA testing successfully identified HCV viremia in high-risk PLWH with a testing cost reduction of 84.5%. Simulation analysis offered detailed information regarding the selection of pool and mini-pool sizes in settings of different HCV epidemiology and the performance of HCV RNA testing to optimize the cost reduction.

The effects of researcher-composed music at mealtime on agitation in nursing home residents with dementia.

This study examined the effects of music at mealtimes on agitation in 22 nursing home residents with dementia. We used a pretest-posttest research design. We played researcher-composed music to residents at each of two mealtimes daily over a consecutive 4-week period. We observed and recorded agitation 24 hours daily for the 4-week period and the following 2-week period. Results revealed a significant decline in mean agitation scores. A cumulative dose effect and a short-term linger effect were observed. Findings suggest that soothing music may be beneficial in managing agitation in nursing home residents with dementia.

Acute HIV infection with presentations mimicking acalculous cholecystitis: A case report.

RATIONALE: Acute retroviral syndrome is the symptomatic presentation of acute human immunodeficiency virus (HIV) infection, which often manifests as a self-limited infectious mononucleosis-like syndrome and occurs 2 to 6 weeks after exposure to HIV. Atypical manifestations including hepatitis, meningitis, or hemophagocytic lymphohistiocytosis have been reported. However, manifestations of acute acalculous cholecystitis during acute HIV infection are rarely reported. PATIENT CONCERNS: A 30-year-old man with nausea and loose stools, followed by fever and abdominal pain at the right upper quadrant for 10 days. DIAGNOSIS: Acute retroviral syndrome, complicated with acute acalculous cholecystitis. INTERVENTIONS: Percutaneous transhepatic gallbladder drainage was performed and treatment with co-formulated bictegravir/emtricitabine/tenofovir alafenamide was initiated upon HIV diagnosis. OUTCOMES: The patient's symptoms improved after the drainage. The levels of liver enzyme including aspartate transaminase alanine aminotransferase decreased to a level within normal limits 1 month after initiation of antiretroviral therapy. CONCLUSION: Acalculous cholecystitis in combination with acute hepatitis could be manifestations of acute HIV infection. For individuals at risk of acquiring HIV infection who present with manifestations of acute acalculous cholecystitis, HIV testing should be considered.

Recently acquired hepatitis C virus infection among people living with human immunodeficiency virus at a university hospital in Taiwan.

BACKGROUND: Little is known about the engagement in hepatitis C virus (HCV) care and completion of HCV treatment in people living with human immunodeficiency virus (HIV) (PLWH) who have HCV coinfection in the Asia-Pacific region. Examining the HCV care cascade can identify barriers to the completion of HCV treatment and facilitate achievement of HCV micro-elimination in PLWH. AIM: To investigate the care cascade of incident HCV infections among PLWH in Taiwan. METHODS: PLWH with incident HCV infections, defined as HCV seroconversion, were retrospectively identified by sequential anti-HCV testing of all archived blood samples at National Taiwan University Hospital between 2011 and 2018. All PLWH with incident HCV infections were followed until December 31, 2019. The care cascade of HCV examined included all incident HCV-infected patients, the percentages of anti-HCV antibodies detected by HIV-treating physicians in clinical care, plasma HCV RNA load tested, HCV RNA positivity diagnosed, referral to treatment assessment made, anti-HCV treatment initiated, and sustained virologic response achieved. Those who had HCV seroconversion during the interferon (IFN) era (2011-2016) and the direct-acting antiviral (DAA) era (2017-2018) were analyzed separately. The duration of HCV viremia-from the date of seroconversion to viral clearance by treatments or until the end of observation-and the incidence of sexually transmitted infections (STIs) during the HCV viremic period were estimated. RESULTS: During the study period, 287 of 3495 (8.2%) PLWH (92.3% being men who have sex with men) who were HCV-seronegative at baseline developed HCV seroconversion by retrospective testing of all archived blood samples. Of the 287 incident HCV infections, 277 (96.5%) had anti-HCV antibodies detected by HIV-treating physicians, 270 (94.1%) had plasma HCV RNA determined and 251 (87.5%) tested positive for HCV RNA. Of those with HCV viremia, 226 (78.7%) were referred to treatment assessment, 215 (74.9%) initiated anti-HCV treatment, and 202 (70.4%) achieved viral clearance. Compared with that in the IFN era, the median interval from HCV seroconversion by retrospective testing to detection of HCV seropositivity by HIV-treating physicians was significantly shorter in the DAA era {179 d [interquartile range (IQR) 87-434] vs 92 d (IQR 57-173); P < 0.001}. The incidence rate of STIs in the DAA vs the IFN era was 50.5 per 100 person-years of follow-up (PYFU) and 38.5 per 100 PYFU, respectively, with an incidence rate ratio of 1.31 (95% confidence interval 0.96-1.77), while the duration of HCV viremia was 380 d (IQR 274-554) and 735 d (IQR 391-1447) (P < 0.001), respectively. CONCLUSION: While anti-HCV therapies are effective in achieving viral clearance, our study suggests more efforts are needed to expedite the linkage of PLWH diagnosed with incident HCV infections to HCV treatment.

Trends of recent hepatitis C virus infection among HIV-positive men who have sex with men in Taiwan, 2011-2018.

BACKGROUND: Increasing trends of HCV infection have been reported among HIV-positive men who have sex with men (MSM) in Europe, Australia and North America. The trends of recently acquired HCV infection among HIV-positive MSM are less clear in Asia-pacific region. METHODS: All HIV-positive patients seeking care at a university hospital in Taiwan tested for anti-HCV IgG at least once annually to estimate the incidence of HCV seroconversion during 2011-2018. HCV genotyping and sequencing were performed and multivariate logistic regression analysis was conducted to identify the factors associated with HCV seroconversion among MSM. FINDINGS: During the study period, 3495 HCV-seronegative patients (86·4% MSM) were included and 294 (8·4%) with recent HCV infection were identified, in whom 281 (95·6%) were MSM, during a total of 16,361·86 person-years of follow-up (PYFU), giving an overall incidence rate of 17·97 per 1000 PYFU, which increased from 14·28 per 1000 PYFU in 2011 to 25·38 per 1000 PYFU in 2018 (p<0·001). HCV seroconversion among MSM was associated with aspartate aminotransferase ≥37 U/L (adjusted odds ratio [AOR] 7·50, 95% CI 4·17-13·50), alanine aminotransferase ≥41 U/L (AOR 7·47, 95% CI 4·11-13·58), and syphilis acquisition (AOR 2·88, 95% CI 1·67-4·97). Among the 277 (94·2%) with HCV viremia, genotype 2a (n = 116) was the leading genotype, followed by 1b (n = 85), 6a (n = 34), and 1a (n = 21). Genotypes 3a and 6a increased from 0% and 5·2%, respectively, in 2011-2014 to 4·1% and 17·1% in 2015-2018. Phylogenetic analysis revealed increased clusters in genotypes 2a, 3a and 6a from 2011-2014 to 2015-2018. INTERPRETATION: An expanding HCV epidemic among HIV-positive MSM is occurring in Taiwan. Improving access to HCV testing and early linkage to treatment are needed to curb the expanding HCV epidemic. FUNDING: This research was supported by a grant from National Taiwan University Hospital, Taipei, Taiwan (NTUH.106-003347 to Hsin-Yun Sun).

Molecular epidemiology and clinical features of adenovirus infection in Taiwanese children, 2014.

BACKGROUND/PURPOSES: Human adenovirus (HAdV) infection is prevalent and has an important clinical impact on children. We aim to investigate the molecular epidemiology of HAdV infection and discover the correlations between clinical features and HAdV species in an HAdV outbreak of 2014. METHODS: This is a retrospective study, enrolling patients under 19 years of age with HAdV infection at the National Taiwan University Hospital in 2014. We gathered the demographic and clinical data, carried out molecular typing and constructed a phylogenetic tree. Statistical analyses were performed in terms of HAdV species and hospitalization. RESULTS: A total of 531 patients with HAdV infection were identified. HAdV-B accounted for the largest proportion (n = 387, 73%). On average, patients infected with HAdV-E were oldest, whereas those with HAdV-C infection were youngest (p < 0.001). Patients with HAdV-B (HAdV-3) infection were associated with a lower incidence of co-infection with other viruses (p < 0.001). Complications occurred in 203 (38%) patients. There were 149 (28%) patients requiring hospitalization. The risk factors for hospitalization included underlying neurological abnormalities, prematurity and the diagnosis of pneumonia. Five patients (1%) had severe HAdV infection requiring intensive care; all of them fully recovered. The phylogenetic study showed that the partial hexon genes of HAdV-1, HAdV-3, HAdV-4 and HAdV-5 remain stable over time. CONCLUSION: We established the molecular epidemiology of HAdV infection and demonstrated the relationship between clinical features and HAdV species.

Comparison of three automated urinalysis systems--Bayer Clinitek Atlas, Roche Urisys 2400 and Arkray Aution Max for testing urine chemistry and detection of bacteriuria.

BACKGROUND: Our study is aimed to determine the performance of 3 automated urinalysis systems-Clinitek Atlas, Urisys 2400 and Aution Max. METHODS: One thousand urine specimens were analyzed with the 3 automated systems. The results of the 3 assays were compared for testing urine chemistry and evaluating the capacity of leukocyte esterase and nitrite to detect bacteriuria. RESULTS: The correlation between the 3 instruments represented as within 1 grading difference was better between the Atlas and Aution Max systems for pH, blood, glucose, urobilinogen, ketone and specific gravity. For protein and nitrite, better correlation was observed between the Atlas and Urisys 2400, while the Aution Max and Urisys 2400 conveyed better correlation for bilirubin and white blood cells. The sensitivity and specificity of both the leukocyte esterase and nitrite in screening for significant bacteriuria were 71.7, 58.9, 70.8% and 99.1, 99.1 and 97.2%, for the Clinitek Atlas, Aution Max and Urisys 2400, respectively. CONCLUSIONS: The automated urinalysis systems demonstrate acceptable correlations with each other in urine chemistries, especially between the Clinitek Atlas and Aution Max systems on the majority of items. The specificity and negative predictive value of leukocyte esterase and nitrite of the 3 instruments for screening of significant bacteriuria were sufficient to avoid unnecessary urine culture.

Evaluation of performance of human immunodeficiency virus antigen/antibody combination assays in Taiwan.

BACKGROUND: The fourth-generation human immunodeficiency virus (HIV) combination assay, which can simultaneously detect the presence of anti-HIV antibody and HIV antigen, has been shown to shorten the window period in HIV diagnosis compared with the third-generation HIV antibody immunoassay. This study was aimed to determine the performance of HIV combination assays in Taiwan, where the HIV-1 seroprevalence is 0.007% and HIV-2 infection has never been reported. METHODS: Performance of three fourth-generation HIV Ag/Ab combination assays (Dia.Pro, Wantai, and Bio-Rad) and one third-generation HIV Ab immunoassay (AxSYM HIV 1/2 gO) was assessed. RESULTS: A total of 152 specimens, including 86 confirmed HIV-seropositive and 66 HIV-seronegative samples, were used in the study. The sensitivity of four assays varied from 98.8% to 100%, and specificity varied from 98.5% to 100%. Performance of the 75 equivocal samples, the HIV status of which was confirmed later, in terms of negative prediction varied from 81.8% to 87.5%. The Bio-Rad and Dia.Pro assays exhibited higher sensitivity for the detection of p24 antigen among the three fourth-generation HIV combination assays. CONCLUSION: The three fourth-generation HIV Ag/Ab combination assays exhibited better sensitivity, specificity, and negative prediction than the third-generation HIV Ab immunoassay.

Pseudo-outbreak of rotavirus infection in a neonatal intensive care unit.

BACKGROUND: A rotavirus outbreak in a neonatal intensive care unit (NICU) may have catastrophic consequences for young infants receiving critical care. From May 13, 2011 to July 11, 2011, a significant increase in stool samples testing positive for rotavirus antigens in the NICU of a university affiliated hospital was observed. Due to lack of clinical presentations suggestive of rotavirus infection in the patients and the rarity of rotavirus infection in the NICU in the past, a pseudo-outbreak was suspected. METHODS: Infection control measures were reinforced initially. To investigate the outbreak, a prospective laboratory-based active surveillance of all infants in the NICU was conducted right after the cluster was identified. Repeated testing using a modified enzyme immunoassay (EIA) kit, rotavirus RNA polyacrylamide gel electrophoresis (PAGE), reverse transcription polymerase chain reaction (RT-PCR), and retrospective chart review methods were used to confirm the pseudo-outbreak. RESULTS: Seven infants in the NICU, with or without gastrointestinal symptoms, tested positive for the rotavirus antigen using the old version of an EIA kit, which indicated a possible outbreak. Active surveillance with repeated tests for recollected stool samples using a modified EIA kit showed negative results in all 24 infants in the NICU. Seven stored stool samples from four infants, which previously tested positive for the rotavirus antigen, tested negative for rotavirus using the modified EIA kit, PAGE, and RT-PCR. Chart reviews showed no clinical difference between index cases and controls. False positivity might arise from unsatisfactory specificity of the old EIA kit. After the introduction of the modified EIA kit, no rotavirus was detected in the NICU for at least 7 months. CONCLUSION: This cluster of patients who tested positive for the rotavirus antigen in stools was confirmed to be a pseudo-outbreak. Interpretation of the old EIA for rotavirus in an NICU setting should be done with caution until the mechanism of the false-positive reaction is elucidated.