A feasibility study of quantitative respirator fit testing by controlled negative pressure

The feasibility of using a direct measure of respirator leakage flow rate as a quantitative index of respirator face seal fit has been explored through the use of a new controlled negative pressure method. The method is based on exhausting air from a temporarily sealed respirator facepiece at a rate sufficient to generate and then sustain a constant negative pressure inside the facepiece while the wearer holds his breath. The magnitude of the negative pressure is preselected to replicate the mean inspiratory pressure inside the mask during normal wear. With the air-purifying paths into the respirator temporarily blocked, measurement of the exhaust flow rate yields a synonymous measure of the leakage flow rate into the mask during inspiration under normal use conditions. The feasibility of using the new method to quantify respirator fit was assessed in a preliminary study that compared its performance with a quantitative fit test method based on the use of dichlorodifluoromethane as a challenge agent. Study data exhibit a high degree of correlation (r greater than 0.99) and no significant difference between the two methods over a range of controlled mask leakage rates. A major advantage of the new method is that a worker can be fit tested with his assigned respirator because the method does not require a destructive sampling probe. Other significant benefits compared to current methods used to quantify respirator fit appear to include (1) ease of test administration, (2) simplicity of test components, (3) lack of a potentially toxic challenge agent, (4) a straightforward calibration procedure, (5) multiple test capability, (6) immediacy of test results, and (7) field portability of the test system.     

Correlation of qualitative and quantitative results from testing respirator fit

Three qualitative respirator fit tests were evaluated for their ability to adequately measure respiratory protection. The evaluated methods were the negative pressure test, the isoamyl acetate test, and the irritant smoke test. Each test was performed concurrently with a single quantitative fit test, the dioctylphthalate (DOP) test, during 274 half-mask and 274 full facepiece wearings. The quantitative values of DOP penetration obtained after passing or failing each qualitative fit test were lognormally distributed. For each qualitative test performed on each mask type, the average log penetration values obtained after passing and failing each test were statistically different from each other. The mean of the log penetration values associated with the failed qualitative test was always larger than the mean of the log penetration values associated with passed qualitative tests for all three qualitative methods. Most (95%) of the tested study had adequately fitting respirators as determined by quantitative testing. Of these subjects, 96% to 100% passed the qualitative fit tests. Of the 5% of the study subjects with inadequately fitting half mask respirators, 93% to 100% of the inadequate fits were detected by qualitative methods. Twenty three to 46% of the poorly fitting full face masks were detected by qualitative methods. The probability of passing or failing a qualitative test with an inadequately fitting respirator can be estimated; however, the uncertainty associated with each estimate is large due to the small number of study subjects with poorly fitting respirators.     

Noninvasive, quantitative respirator fit testing through dynamic pressure measurement

A new method has been invented for the noninvasive and quantitative determination of fit for a respirator. The test takes a few seconds and requires less expensive instrumentation than presently used for invasive testing. In this test, the breath is held at a negative pressure for a few seconds, and the leak-induced pressure decay inside the respirator cavity is monitored. A dynamic pressure sensor is attached to a modified cartridge of an air-purifying respirator or built into the respirator body or into the air supply line of an air-supplied respirator. The method is noninvasive in that the modified cartridge can be mounted onto any air-purifying respirator. The pressure decay during testing quantifies the airflow entered through the leak site. An equation has been determined which gives the air leakage as a function of pressure decay slope, respirator volume and the pressure differential during actual wear--all of which are determined by the dynamic pressure sensor. Thus, the ratio of air inhaled through the filters or via the air supply line to the leak rate is a measure of respirator fit, independent of aerosol deposition in the lung and aerosol distribution in the respirator cavity as found for quantitative fit testing with aerosols. The new method is shown to be independent of leak and sensor locations. The concentration and distribution of aerosols entered through the leak site is dependent only on the physical dimensions of the leak site and the air velocity in it, which can be determined independently.(ABSTRACT TRUNCATED AT 250 WORDS)     

Experiments supporting the use of ambient aerosols for quantitative respirator fit testing

Most methods for testing facial seal leakage on subjects undergoing respirator fit tests involve comparing the generated aerosol particulate concentration inside the subject's respirator to the concentration in a test chamber. These aerosols are produced by fogging substances such as corn oil, dioctyl sebacate, or dioctyl phthalate (DOP) into the test chamber. The health effects of these substances and of their aerosols on respiratory systems are uncertain. The proposed alternate method uses as a test medium ambient particles which exist in most room atmospheres. The proposed method eliminates the need for a test chamber and for an intentionally produced aerosol. The subject is tested for respirator inleakage by comparing the particulate count concentration inside the subject's respirator to that of the room atmosphere outside the respirator. This method is less expensive and simpler to administer than the use of oil or other deliberately produced aerosols because it uses an existing ambient test medium. Statistical analysis of the test data indicates favorable comparison with the conventional chamber-aerosol method.     

A modified protocol for quantitative fit testing using the PortaCount

A modified quantitative fit testing method has been developed for testing half masks using the TSI PortaCount respirator fit tester. This approach focuses on shortening the time for each exercise during fit testing; however, the shortened protocol is applied only to the very good-fitting masks. For marginal-fitting masks, the testing is carried out according to the full Occupational Safety and Health Administration (OSHA) respiratory protection standard (29CFR1910.134).(1) The shortened protocol (currently not approved by OSHA) still uses all the exercises required by the OSHA standard but for a shorter time (30 seconds [s] for each exercise instead of the usual 60 s). How good the fit has to be to qualify for a shortened exercise is determined by the statistical analysis of a large data set containing pass and fail fit-test data. The statistical analysis involves calculating the sensitivity and specificity of the pass and failed fit tests on half masks. From this analysis, a multiplication factor (K) to the OSHA pass/fail criterion was developed. For a respirator to undergo the shortened protocol, the fit factor obtained during any exercise must be K times the OSHA pass/fail criterion of 100 for half masks. Hence, this approach is more conservative than fit testing protocols that involve shortened exercises regardless of the fit. Nevertheless, this approach still saves time without compromising the accuracy of the fit test expressed in terms of sensitivity and specificity. For the existing data, 85 percent of the fit tests would have been performed according to the faster test protocol while only 15 percent of the tests would have been tested according to the full-length OSHA test protocol.     

A comparison of controlled negative pressure and aerosol quantitative respirator fit test systems by using fixed leaks

An automated version of a new method for quantitative respirator fit testing by controlled negative pressure was compared with a computerized aerosol fit test system. The controlled negative pressure technique eliminates many of the problems associated with aerosol and pressure decay fit test methods. A series of fixed leaks was used to compare the leak measurement capabilities of the controlled negative pressure system against a standard computerized aerosol fit test system. Negative pressure and aerosol fit factors determined for a series of fixed leaks through hypodermic needles were highly correlated with each other (r = 0.998) and with the cross-sectional areas of the leak needles (r greater than 0.995).     

Improved technique that allows the performance of large-scale SNP genotyping on DNA immobilized by FTA technology.

FTA technology is a novel method designed to simplify the collection, shipment, archiving and purification of nucleic acids from a wide variety of biological sources. The number of punches that can normally be obtained from a single specimen card are often however, insufficient for the testing of the large numbers of loci required to identify genetic factors that control human susceptibility or resistance to multifactorial diseases. In this study, we propose an improved technique to perform large-scale SNP genotyping. We applied a whole genome amplification method to amplify DNA from buccal cell samples stabilized using FTA technology. The results show that using the improved technique it is possible to perform up to 15,000 genotypes from one buccal cell sample. Furthermore, the procedure is simple. We consider this improved technique to be a promising methods for performing large-scale SNP genotyping because the FTA technology simplifies the collection, shipment, archiving and purification of DNA, while whole genome amplification of FTA card bound DNA produces sufficient material for the determination of thousands of SNP genotypes.     

New respirator fit test panels representing the current U.S. civilian work force

The fit test panels currently used for respirator research, design, and certification are 25-subject panels developed by Los Alamos National Laboratory (LANL) and are based on data from the 1967 and 1968 anthropometric surveys of U.S. Air Force personnel. Military data do not represent the great diversity in face size and shape seen in civilian populations. In addition, the demographics of the U.S. population have changed over the last 30 years. Thus, it is necessary to assess and refine the LANL fit test panels. This paper presents the development of new respirator fit test panels representative of current U.S. civilian workers based on an anthropometric survey of 3,997 respirator users conducted in 2003. One panel was developed using face length and face width (bivariate approach) and weighting subjects to match the age and race distribution of the U.S. population as determined from the 2000 census. Another panel was developed using the first two principal components obtained from a set of 10 facial dimensions (age and race adjusted). These 10 dimensions are associated with respirator fit and leakage and can predict the remaining face dimensions well. Respirators designed to fit these panels are expected to accommodate more than 95% of the current U.S. civilian workers. Both panels are more representative of the U.S. population than the existing LANL panel and may be appropriate for testing both half-masks and full-face piece respirators. Respirator manufacturers, standards development organizations, and government respirator certification bodies need to select the appropriate fit test panel for their particular needs. The bivariate panel is simpler to use than the principal component analysis (PCA) panel and is most similar to the LANL panel currently used. The inclusion of the eight additional facial measurements allows the PCA panel to provide better criteria for excluding extreme face sizes from being used. Because the boundaries of the two new panels are significantly different from the LANL panel, it may be necessary to develop new respirator sizing systems. A new five-category sizing system is proposed.     

Comparison of N95 disposable filtering facepiece fits using bitrex qualitative and TSI Portacount quantitative fit testing

As a means of evaluating the use of denatonium benzoate (bitrex) as a qualitative fit test agent with filtering facepiece respirators, the bitrex qualitative and TSI Protacount(R) quantitative fit-test methods were compared using N95 filtering facepieces. Seventy-nine paired tests (trial) were performed. Detection of bitrex during a qualitative fit test or measurement of a fit factor of <100 during a quantitative fit test constituted a failure. Qualitative and quantitative methods were performed using identical test protocols. Data were analyzed using pass/fail criteria, and matched-pair analysis methods were applied. The results of this study indicate that the use of bitrex during qualitative fit testing of N95 disposable filtering facepieces results in an increase in failure and/or rejection in cases where a TSI Portacount (plus N95 companion accessory) quantitatively establishes an acceptable fit.     

An assessment of critical anthropometric dimensions for predicting the fit of a half-mask respirator.

The purpose of this study was to determine if facial dimensions for a group of subjects were predictive of the fit factors measured while one brand of half-mask respirator was worn. Fit factors and 12 facial dimensions measured on 30 female and 38 male subjects were analyzed by correlation coefficients; weighted, multiple linear regression; and discriminant analysis. Data were analyzed for all subjects, gender subgroups, a race subgroup (whites only), and race/gender subgroups. Significant correlation coefficients with the log-transformed fit factors were found for four dimensions; four dimensions had significant coefficients in four or more multiple linear regression models. Only two dimensions had significant coefficients in four or more discriminant analysis models. Menton-subnasale (lower face) length was the only dimension included in all three of these groups. Gender-specific regression models had very high coefficient of determination values (R2 > 0.85). Discriminant analysis of the data for all subjects and race/gender subgroups found very good predictive scores for statistical software-generated models and menton-subnasale length alone; these scores were significantly better than those for the model with the respirator test panel dimensions (face length and lip width). These analyses found that facial dimensions were good predictors of respirator fit for those subjects wearing one brand of half-mask respirator. Lower face length was consistently indicated as being correlated or associated with fit. These results would indicate that dimensions other than those currently used may be more appropriate to define a half-mask respirator test panel.     

A new technique for quantitative bacterial assessment on burn wounds by modified dermabrasion

Bacterial colonization and invasive bacterial infection is still one of the major problems in the treatment of burn victims. The standard procedures of bacterial monitoring of the burn would are i) swab-culture which is non-invasive but detects bacteria at the very surface and ii) biopsy-culture which gives a more complete view but has the disadvantage of being invasive. Therefore we developed a new technique for examination of microbial colonization of the wound surface. Dermabrasion of the upper layers of the wound was performed using a small rotating carbon-steel disc of defined roughness. The tissue samples obtained were analysed for bacterial growth in different culture media. Results were qualitatively and quantitatively compared with those of standard techniques performed in parallel. Our results show that this new technique is superior to the swab culture in identifying different bacterial species. The results can be compared with the biopsy technique, but has the advantage of being less invasive.     

定量态势分析法分析我国基因检测服务发展影响因素的研究

目的研究我国以基因组技术为基础的基因检测服务发展影响因素及发展策略。方法通过目的抽样的方法选择基因组学和基因检测领域相关专家,对11名专家进行深入访谈并设计问卷,通过调查问卷获取25名专家的数据信息,态势分析法、层次分析法、内部因素评价矩阵和外部因素评价矩阵相结合的定量态势分析法进行数据分析,随机一致性比率（CR）检验逻辑一致性（CR〈10％）。结果共确定15项关键影响因素,其中重要性排在前三位的分别是法律与市场规范缺失、国家已出台政策扶持和缺少知识产权保护,权重分别为0．099、0．091和0．087,国内基因检测服务发展处于战略态势图的第三象限。结论国内基因检测服务发展宜采取防御性战略,回避外部威胁,克服自身缺点,降低基因检测所带来的风险。     

Review of respirator performance testing in the workplace: issues and concerns.

Performance capability of respirators has traditionally been evaluated by testing components of the respirator (e.g., filter efficiency), facepiece fit, total inward leakage, or some other measure of performance evaluated under laboratory conditions. In recent years, increased emphasis has been placed on development of test methods suitable for evaluating respirator performance in the workplace. The goal of such testing is to evaluate the level of protection provided by respirators in the work environment. The AIHA Respiratory Protection Committee believes that workplace testing of respirators has the potential to be an excellent tool for increasing knowledge about the effectiveness of respiratory protection. However, a number of technical issues remain to be addressed before optimal test protocols and data analysis methods can be defined. The progress made to date in workplace testing will be reviewed, and broader discussion about key elements that must be considered when developing guidelines for testing respirators in the workplace will be initiated.     

A new tool for sampling airborne isocyanates.

A new sampling system is presented that uses solid sorbent media contained in a tube for the determination of airborne isocyanates (2.4-2.6 toluene diisocyanate, hexamethylene diisocyanate, and 4.4' diaminodiphenylmethane diisocyanate). The method is compared with the National Institute for Occupational Safety and Health (NIOSH) Method P&CAM 5505 (Revision #1). Experimental tests yielded results that were highly concordant with the NIOSH method.