Critical evaluation of a CLIA-waived streptococcal antigen detection test in the emergency department.

STUDY OBJECTIVE: We compare the performance of a Clinical Laboratory Improvement Amendments (CLIA)-waived antigen detection test (ADT) analyzed in the emergency department and a CLIA moderately complex ADT performed in the hospital microbiology laboratory. METHODS: Samples from throat swabs were obtained using a double-headed Culturette II (Becton Dickinson Medical Systems, Sparks, MD) from a consecutive sample of 322 patients 3 years or older who presented to the ED of a university-affiliated pediatric referral hospital with the complaint of sore throat during 1998. One swab was transported to the microbiology laboratory and analyzed using a CLIA moderately complex ADT; negative results were confirmed using sheep blood agar culture. The second swab remained in the ED where a nurse conducted a CLIA-waived ADT. The accepted standard for documentation of group A beta-hemolytic streptococcal (GABHS) infection was either a positive moderately complex ADT or culture result. The time of specimen collection, as well as the time the ED results and microbiology laboratory results were available to treating physicians, were recorded. Main outcome measures were concordance (kappa statistic), sensitivity, and turnaround time (Mann-Whitney U test). RESULTS: Three hundred twenty-two patients (mean age 7.5 years) had both ADTs performed. One hundred one (31%) patients had documented GABHS in the microbiology laboratory; 83 (82%) had a positive ADT result in the microbiology laboratory, and 18 (18%) had a positive culture result after a negative moderately complex ADT result. In 299 patients or 93% (95% confidence interval [CI] 90.8%, 95.8%) of patients, the waived ADT and the moderately complex ADT results were concordant (kappa 0.82; 95% CI 0.78, 0.86; P <.001). The sensitivity of the waived ADT was 80%; the sensitivity of the moderately complex ADT approximated 82% (difference of 2%; 95%CI -3%, 7%). The median times from swab specimen collection to availability of ADT results were 10 minutes (range 3 to 37 minutes) for the waived ADT and 35 minutes (range 5 to 162 minutes) for the moderately complex ADT (P <.001) with a difference of 25 minutes (95% CI 22.4, 27.6 minutes). CONCLUSION: In this study, an ED CLIA-waived rapid streptococcal throat test performed as well as its equivalent CLIA-regulated laboratory test. Further, the ED test provided results more rapidly than the laboratory test. Our results also validate previous work that negative rapid throat test results in pediatric patients in the ED should be confirmed by standard throat culture.

Bronchiolitis-associated mortality and estimates of respiratory syncytial virus-associated deaths among US children, 1979-1997.

A 1985 estimate that 4500 respiratory syncytial virus (RSV)-associated deaths occur annually among US children has not been updated using nationally representative data. Thus, 1979-1997 multiple cause-of-death records for children <5 years old listing bronchiolitis, pneumonia, or any respiratory tract disease were examined. Deaths among children associated with any respiratory disease declined from 4631 in 1979 to 2502 in 1997. During the 19-year study period, 1806 bronchiolitis-associated deaths occurred (annual mean, 95 deaths; range, 66-127 deaths). Of these deaths, 1435 (79%) occurred among infants <1 year old. Congenital heart disease, lung disease, or prematurity was listed in death records of 179 (9.9%), 99 (5.5%), and 76 (4.2%) children dying with bronchiolitis, respectively. By applying published proportions of children hospitalized for bronchiolitis or pneumonia who were RSV-infected to bronchiolitis and pneumonia deaths, it was estimated that < or =510 RSV-associated deaths occurred annually during the study period, fewer than previously estimated.

Does the use of ultrasonography improve the outcome of children with appendicitis?

OBJECTIVE: To determine whether the use of ultrasonography (US) improves the outcome of children with appendicitis. METHODS: All cases of patients (<17 years old) with pathologically confirmed appendicitis treated in the ED between July 1992 and December 1995 were retrospectively reviewed. RESULTS: 231 charts met criteria for analysis. 100 (43%) patients had US prior to surgery. Age, race, and insurance status were similar for children in the US and non-US groups; there were no differences between the groups at presentation in mean temperature, mean WBC count, or percentage of children with vomiting, diarrhea, abdominal tenderness, or guarding. Those in the non-US group were more often male (71%, p=0.002) and more frequently had right lower quadrant pain (65%, p=0.003). Time from ED triage to the OR was 17.1 hours (US group) vs 10.4 hours (non-US group) (p=0.002). The perforation rates and the complication (abscess, wound infection, wound dehiscence) rates were similar for children in the two groups. Hospital charges were higher in the US group than in the non-US group ($14,123 vs $13,021, p=0.007). CONCLUSION: The use of US did not result in early diagnosis of appendicitis, nor was it associated with a reduction in perforation or complication rates. Among children with clinical evidence of appendicitis, US was associated with a delay in surgery and an increase in hospital charges.