A kinetic enzyme immunoassay for the quantitation of antibodies to a humanized monoclonal antibody in human serum.

A kinetic enzyme immunoassay was developed and validated to quantitate human antibodies to the humanized monoclonal antibody CAMPATH1-1H (C1H) in human serum. The assay was configured using C1H-coated 96-well plates which were blocked with bovine serum albumin, and incubated with dilutions of human serum containing anti-C1H antibody. Antibody was detected using biotinylated C1H followed by streptavidin-conjugated alkaline phosphatase and p-nitrophenyl phosphate. Absorbance data were collected for 10 min, and mOD min-1 data were exported to MultiCalc data analysis software. A 4-parameter logistic-log algorithm was shown to model the data through the range of the standard curve within 15% of nominal values. The overall assay performance coefficient of variation by ANOVA was 9.2%. The lower limit of detection was defined at 160 Units ml-1. The anti-idiotype antibody standard stock solution is stable at 4 degrees C and at -80 degrees C for at least 11 months in buffer. The anti-idiotype antibody controls are stable for at least seven freeze-thaw cycles and at least 6 months in human serum stored at -20 degrees C. A strategy was devised by which to establish the specific antibody potency for any given batch of anti-C1H antibody standard relative to the Reference Standard. This EIA has been used to quantify and characterize anti-C1H antibody in human serum in support of clinical safety and efficacy studies.

Essential food hygiene certificate examination: examination papers reviewed.

One thousand papers for the Essential Food Hygiene examination, chosen consecutively from those being processed in RSH House on 6-7 April 1994, were reviewed. The purpose of the review was to assess the impact of the redesigned course and the new examination papers which were introduced from 1 January 1994. The pass rate for the sample was 96.7% which was somewhat lower than the pass rate of 99.2% for the whole of 1993 when the previous examination papers were in use. Out of 1000 papers 33 were failures. Eighteen candidates had obtained the 70% pass mark yet still failed because one of the two questions on temperature control had been answered incorrectly. The requirement to answer both those questions correctly in order to obtain a certificate was introduced with the new examination papers and marked a major change. The conclusion from this snapshot study was that the majority of Tutors and the candidates from their courses had achieved a high degree of examination success. In particular, Tutors had secured a major objective by ensuring that trainees had a clear understanding of the concepts of temperature control. Only a minority were having difficulty. Of the 33 individuals who failed, 18 came from just four of the 108 courses.

Teeside coronary survey--fatality and comparative severity of patients treated at home, in the hospital ward, and in the coronary care unit after myocardial infarction.

An epidemiological survey of myocardial infarction in Teesside County Borough was completed between April 1972 and April 1973. Cases were notified and divided into those who had suffered a 'definite', 'possible', or 'not' myocardial infarction. Severity factors were measured in the 'definite' cases and the distribution of the various factors studied among home, ward, and coronary care unit treated cases. Increasing severity was found to be related to increased fatality. The fatality of patients treated at home was less than that of those treated in the ward or the coronary care unit. Those who survived to be treated at home were not less severe than those who survived in a comparable group to be treated in hospital using the objective criteria described in the assessment of severity. It is emphasised that the results must be interpreted with caution as other essentially subjective criteria not so easily measurable, but which might have been of considerable influence in the assessment of severity, were not measured in this study.

Teesside coronary survey: an epidemiological study of acute attacks of myocardial infarction.

A 12-month epidemiological survey of attacks of acute myocardial infarction was carried out in a large urban population. The incidence and mortality at all ages and in both sexes were examined. Altogether, 1938 attacks were diagnosed--an overall incidence of 4-89 per 1000 population. The 28-day fatality rate was 50-5%. A third of the patients were treated at home and these patients had a lower fatality rate than those in hospital, a difference that could not be attributed to age, sex, or severity of attack. Half of the deaths that were witnessed occurred suddenly and a further 21% occurred within the next two hours. The median time to patients coming under care was about three hours. As used at present, coronary care units are unlikely to improve fatality rates. Future advances in treatment must take place outside hospital and will require re-education of the public and the general practitioner.

Anxiety after a heart attack.

An objective measurement of anxiety at defined intervals after the onset of acute cardiac symptoms was made in 203 men admitted to the Coronary Care Unit, Royal Infirmary of Edinburgh, and in 83 patients in a Teesside coronary survey. Of the Teesside patients, 50 were treated at home, 22 were admitted initially to a coronary care unit, and 11 were admitted directly to a general medical ward. In the Edinburgh patients the level of anxiety was high early in the illness, fell rapidly, and rose again towards the end of their stay in hospital. At 4 months it was that of a normal population. After transfer from the coronary care unit the group was not more anxious than other patients in the ward. Reaction to the illness was unrelated to its physical severity. Patients who reacted badly at the beginning were less likely to return to work. The pattern of anxiety in the Teesside patients resembled that of the Edinburgh group, and reaction to illness was largely independent of physical aspects. Treatment in hospital, either through a coronary care unit initially or in a medical ward, did not increase emotional distress. At 3 months patients treated initially in a coronary care unit were less anxious than the others. Throughout the period of study the Teesside patients were more anxious than the Edinburgh patients and outcome was not related to anxiety. Social and environmental differences may account for this.