Frequency and Distribution of Tuberculosis Resistance-Associated Mutations between Mumbai, Moldova, and Eastern Cape.

Molecular diagnostic assays, with their ability to rapidly detect resistance-associated mutations in bacterial genes, are promising technologies to control the spread of drug-resistant tuberculosis (DR-TB). Sequencing assays provide detailed information for specific gene regions and can help diagnostic assay developers prioritize mutations for inclusion in their assays. We performed pyrosequencing of seven Mycobacterium tuberculosis gene regions (katG, inhA, ahpC, rpoB, gyrA, rrs, and eis) for 1,128 clinical specimens from India, Moldova, and South Africa. We determined the frequencies of each mutation among drug-resistant and -susceptible specimens based on phenotypic drug susceptibility testing results and examined mutation distributions by country. The most common mutation among isoniazid-resistant (INH(r)) specimens was the katG 315ACC mutation (87%). However, in the Eastern Cape, INH(r) specimens had a lower frequency of katG mutations (44%) and higher frequencies of inhA (47%) and ahpC (10%) promoter mutations. The most common mutation among rifampin-resistant (RIF(r)) specimens was the rpoB 531TTG mutation (80%). The mutation was common in RIF(r) specimens in Mumbai (83%) and Moldova (84%) but not the Eastern Cape (17%), where the 516GTC mutation appeared more frequently (57%). The most common mutation among fluoroquinolone-resistant specimens was the gyrA 94GGC mutation (44%). The rrs 1401G mutation was found in 84%, 84%, and 50% of amikacin-resistant, capreomycin-resistant, and kanamycin (KAN)-resistant (KAN(r)) specimens, respectively. The eis promoter mutation -12T was found in 26% of KAN(r) and 4% of KAN-susceptible (KAN(s)) specimens. Inclusion of the ahpC and eis promoter gene regions was critical for optimal test sensitivity for the detection of INH resistance in the Eastern Cape and KAN resistance in Moldova. (This study has been registered at ClinicalTrials.gov under registration number NCT02170441.).

Longitudinal determinants of consistent condom use by partner type among young injection drug users: the role of personal and partner characteristics.

We investigated the longitudinal influence of individual-, relationship- and social-level factors on condom use by partner type among young injections drug users (IDUs) enrolled in the Collaborative Injection Drug Users Study-III/Drug Users Intervention Trial (CIDUS-III/DUIT) from 2002 to 2004. Based on longitudinal analysis using generalized estimating equations (GEE), consistent condom use with main partners was more commonly reported among males and those with greater self-efficacy for condom use; main partner's desire for pregnancy and needle sharing were negatively associated with consistent condom use. Among those with casual partners, having fewer sex partners was associated with consistent condom use. Positive attitudes toward condom use and partner norms supporting condom use were associated with greater consistent condom use with both partner types. These findings suggest that intervention strategies targeting individual- and partner-level factors may provide avenues for intervening upon sexual risks among young IDUs.

Evaluation of recorded video-observed therapy for anti-tuberculosis treatment.

BACKGROUND: Asynchronous video directly observed therapy (VDOT) may reduce tuberculosis (TB) program costs and the burden on patients. We compared VDOT performance across three cities in the United States, each of which have TB incidence rates above the national average.METHODS: Patients aged ≥18 years who are currently receiving directly observed anti-TB treatment were invited to use VDOT for monitoring treatment. Pre- and post-treatment interviews and medical records were used to assess site differences in treatment adherence and patient characteristics and perceptions.RESULTS: Participants were enrolled in New York City, NY (n = 48), San Diego, CA (n = 52) and San Francisco, CA, USA (n = 49). Overall, the mean age was 41 years (range 18-87); 59% were male; most were Asian (45%) or Hispanic/Latino (30%); and 77% were foreign-born. The median fraction of expected doses observed (FEDO) was 88% (IQR 76-96). At follow-up, 97% thought VDOT was "very or somewhat easy to use" and 95% would recommend VDOT to other TB patients. Age, race/ethnicity, annual income, and country of birth differed by city (P < 0.05), but FEDO and VDOT perceptions did not.CONCLUSIONS: TB programs in three large US cities observed a high FEDO using VDOT while minimizing staff time and travel. Similar findings across sites support VDOT adoption by other large, urban TB programs.

High prevalence of latent tuberculosis infection among injection drug users in Tijuana, Mexico.

BACKGROUND: We studied prevalence and correlates of latent tuberculosis infection (LTBI) among injection drug users (IDUs) in Tijuana, Mexico, where tuberculosis (TB) is endemic. METHODS: IDUs aged > or =18 years were recruited via respondent-driven sampling (RDS) and underwent standardized interviews, human immunodeficiency virus (HIV) antibody testing and LTBI screening using Quanti-FERON((R))-TB Gold In-Tube, a whole-blood interferon-gamma release assay (IGRA). LTBI prevalence was estimated and correlates were identified using RDS-weighted logistic regression. RESULTS: Of 1020 IDUs, 681 (67%) tested IGRA-positive and 44 (4%) tested HIV-positive. Mean age was 37 years, 88% were male and 98% were Mexican-born. IGRA positivity was associated with recruitment nearest the US border (aOR 1.64, 95%CI 1.09-2.48), increasing years of injection (aOR 1.20/5 years, 95%CI 1.07-1.34), and years lived in Tijuana (aOR 1.10/5 years, 95%CI 1.03-1.18). Speaking some English (aOR 0.38, 95%CI 0.25-0.57) and injecting most often at home in the past 6 months (aOR 0.68, 95%CI 0.45-0.99) were inversely associated with IGRA positivity. DISCUSSION: Increased LTBI prevalence among IDUs in Tijuana appears to be associated with greater drug involvement. Given the high risk for HIV infection among Tijuana's IDUs, interventions are urgently needed to prevent HIV infection and treat LTBI among IDUs before these epidemics collide.

Targeted screening and treatment for latent tuberculosis infection using QuantiFERON-TB Gold is cost-effective in Mexico.

OBJECTIVE: To assess the cost-effectiveness of screening for latent tuberculosis infection (LTBI) using a commercially available detection test and treating individuals at high risk for human immunodeficiency virus (HIV) infection in a middle-income country. DESIGN: We developed a Markov model to evaluate the cost per LTBI case detected, TB case averted and quality-adjusted life year (QALY) gained for a cohort of 1000 individuals at high risk for HIV infection over 20 years. Baseline model inputs for LTBI prevalence were obtained from published literature and cross-sectional data from tuberculosis (TB) screening using QuantiFERON-TB Gold In-Tube (QFT-GIT) testing among sex workers and illicit drug users at high risk for HIV recruited through street outreach in Tijuana, Mexico. Costs are reported in 2007 US dollars. Future costs and QALYs were discounted at 3% per year. Sensitivity analyses were performed to evaluate model robustness. RESULTS: Over 20 years, we estimate the program would prevent 78 cases of active TB and 55 TB-related deaths. The incremental cost per case of LTBI detected was US$730, cost per active TB averted was US$529 and cost per QALY gained was US$108. CONCLUSIONS: In settings of endemic TB and escalating HIV incidence, targeting LTBI screening and treatment among high-risk groups may be highly cost-effective.

Prevalence and Correlates of Injecting with Visitors from the United States Among People Who Inject Drugs in Tijuana, Mexico.

Cross-border infectious disease transmission is a concern related to drug tourism from the U.S. to Mexico. We assessed this risk among people who inject drugs (PWID) in Tijuana, Mexico. We measured the prevalence and identified correlates of injecting with PWID visiting from the U.S. among PWID in Tijuana using univariable and multivariable logistic regression. Of 727 participants, 18.5% injected during the past 6 months in Mexico with U.S. PWID described mostly as friends (63%) or acquaintances (26%). Injecting with U.S. PWID was independently associated with higher education [adjusted odds ratio (aOR) = 1.13/year], deportation from the U.S. (aOR = 1.70), younger age at first injection (aOR = 0.96/year), more lifetime overdoses (aOR = 1.08), and, in the past 6 months, backloading (aOR = 4.00), syringe confiscation by the police (aOR = 3.02) and paying for sex (aOR = 2.98; all p-values < 0.05). Nearly one-fifth of PWID in Tijuana recently injected with U.S. PWID, and their reported risk behaviors could facilitate cross-border disease transmission.

Do law enforcement interactions reduce the initiation of injection drug use? An investigation in three North American settings.

BACKGROUND: The prevention of drug injecting is often cited as a justification for the deployment of law enforcement and for the continuation of drug criminalization policies. We sought to characterize the impact of law enforcement interactions on the risk that people who inject drugs (PWID) report assisting others with injection initiation in three North American countries. METHODS: Cross-sectional data from PWID participating in cohort studies in three cities (San Diego, USA; Tijuana, Mexico; Vancouver, Canada) were pooled (August 2014-December 2016). The dependent variable was defined as recently (i.e., past six months) providing injection initiation assistance; the primary independent variable was the frequency of recent law enforcement interactions, defined categorically (0 vs. 1 vs. 2-5 vs. ≥6). We employed multivariable logistic regression analyses to assess this relationship while controlling for potential confounders. RESULTS: Among 2122 participants, 87 (4.1%) reported recently providing injection initiation assistance, and 802 (37.8%) reported recent law enforcement interactions. Reporting either one or more than five recent interactions with law enforcement was not significantly associated with injection initiation assistance. Reporting 2-5 law enforcement interactions was associated with initiation assistance (Adjusted Odds Ratio=1.74, 95% Confidence Interval: 1.01-3.02). CONCLUSIONS: Reporting interactions with law enforcement was not associated with a reduced likelihood that PWID reported initiating others into injection drug use. Instead, we identified a positive association between reporting law enforcement interactions and injection initiation assistance among PWID in multiple settings. These findings raise concerns regarding the effectiveness of drug law enforcement to deter injection drug use initiation.

Correlates of consistent condom use with main partners by partnership patterns among young adult male injection drug users from five US cities.

This paper examined correlates of consistent condom use with a main partner among heterosexual male injection drug users (IDUs). Using data from a multi-site sample of young IDUs, we identified 1770 sexually active men of whom 24% (429/1770) reported an exclusive main female sex partner and 49% (862/1770) reported both main and casual female sex partners. Consistent condom use with a main partner was low among men with an exclusive main partner and those with multiple partners (12% and 17%, respectively). In multivariate analysis, consistent condom use with a main partner across partnership patterns was directly associated with anticipating a positive response to requests for condom use and by partner support of condom use; consistent condom use was inversely associated with a main partner's pregnancy desires. Among men with an exclusive main partner, consistent condom use was also inversely associated with needle sharing with a main partner. Among men with multiple partners, consistent condom use with a main partner was inversely associated with injecting with a used needle and intimate partner violence. The low prevalence of consistent condom use with main female partners among heterosexually active male IDUs indicates an increased risk for HIV transmission between men and their primary sex partners. Interventions for heterosexual males that are geared toward increasing condom use in primary relationships are warranted.

Mycobacterium tuberculosis infection among persons who inject drugs in San Diego, California.

BACKGROUND: Persons who inject drugs (PWID) might be at increased risk for Mycobacterium tuberculosis infection and reactivation of latent tuberculous infection (LTBI) due to their injection drug use. OBJECTIVES: To determine prevalence and correlates of M. tuberculosis infection among PWID in San Diego, California, USA. METHODS: PWID aged 18 years underwent standardized interviews and serologic testing using an interferon-gamma release assay (IGRA) for LTBI and rapid point-of-care assays for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections. Independent correlates of M. tuberculosis infection were identified using multivariable log-binomial regression. RESULTS: A total of 500 participants met the eligibility criteria. The mean age was 43.2 years (standard deviation 11.6); most subjects were White (52%) or Hispanic (30.8%), and male (75%). Overall, 86.7% reported having ever traveled to Mexico. Prevalence of M. tuberculosis infection was 23.6%; 0.8% were co-infected with HIV and 81.7% were co-infected with HCV. Almost all participants (95%) had been previously tested for M. tuberculosis; 7.6% had been previously told they were infected. M. tuberculosis infection was independently associated with being Hispanic, having longer injection histories, testing HCV-positive, and correctly reporting that people with 'sleeping' TB cannot infect others. CONCLUSIONS: Strategies are needed to increase awareness about and treatment for M. tuberculosis infection among PWID in the US/Mexico border region.

Mobility patterns of persons at risk for drug-resistant tuberculosis in Mumbai, India.

SETTING: Tuberculosis (TB) hospital in Mumbai, India. OBJECTIVE: To describe the mobility patterns of persons with suspected drug-resistant tuberculosis (DR-TB) and to assess whether there were significant differences in demographic or risk characteristics based on mobility. DESIGN: Observational cohort study of TB clinic patients at risk for DR-TB. RESULTS: Among 602 participants, 37% had ever moved from their place of birth; 14% were local movers (within state), and 23% were distant movers, between states or countries. Univariate multinomial logistic regression models showed that distant movers were more likely than non-movers to have lower income, less education, a greater number of previous TB episodes, and to have ever smoked. Compared to non-movers, local movers were more likely to have lower income and were more likely to have seen a doctor in the past 2 years. Clinical outcomes, including DR-TB, diabetes, and human immunodeficiency virus (HIV), did not differ between the three mobility groups. CONCLUSION: Mobility was common among patients at risk for DR-TB in Mumbai. TB programs should consider the implications of mobility on the protracted treatment for DR-TB in India.

A performance evaluation of MTBDRplus version 2 for the diagnosis of multidrug-resistant tuberculosis.

OBJECTIVE: To evaluate the performance of a recently updated rapid molecular diagnostic test, GenoType® MTBDRplus version 2, designed to detect drug resistance in both acid-fast bacilli (AFB) smear-negative and -positive specimens. DESIGN: Sputum samples from 1128 patients at risk for multidrug-resistant tuberculosis (MDR-TB) were tested using MTBDRplus v2 and compared with reference standard MGIT™ 960™ drug susceptibility testing. The relationship of participant human immunodeficiency virus (HIV) status, diabetic status, previous treatment, and smear gradation to the likelihood of obtaining an interpretable result was assessed using logistic regression. RESULTS: The sensitivity and specificity of MTBDRplus v2 for detecting MDR-TB, when compared to a reference standard, were respectively 96.0% (95%CI 93.5-97.6) and 99.2% (95%CI 97.0-99.9) in AFB smear-positive specimens and 82.8% (95%CI 63.5-93.5) and 98.3% (95%CI 89.9-99.9) in AFB smear-negative specimens. A dose-response relationship was observed between the proportion of interpretable test results and AFB smear bacterial load after adjusting for age, sex, body mass index, HIV status, previous treatment and diabetic status. CONCLUSION: While MTBDRplus v2 performs well among both AFB smear-positive and -negative specimens, smear gradation appears to influence both the probability of obtaining an interpretable result and test sensitivity, indicating a significant association between bacillary load and test performance.

Factors associated with interest in initiating treatment for hepatitis C Virus (HCV) infection among young HCV-infected injection drug users.

OBJECTIVE: We sought to identify factors associated with interest in receiving therapy for hepatitis C virus (HCV) infection among HCV-infected injection drug users (IDUs) in 3 United States cities. METHODS: IDUs aged 18-35 years who were HCV-infected and seronegative for human immunodeficiency virus underwent surveys on behaviors, experience, and interest in treatment for HCV infection and readiness to quit drug use. RESULTS: Among treatment-naive IDUs (n=216), 81.5% were interested in treatment for HCV infection, but only 27.3% had seen a health-care provider since receiving a diagnosis of HCV infection. Interest in treatment for HCV infection was greater among IDUs with a high perceived threat of progressive liver disease, those with a usual source of care, those without evidence of alcohol dependence, and those with higher readiness scores for quitting drug use. Interest in treatment for HCV infection was 7-fold higher among IDUs who were told by their health-care provider that they were at risk for cirrhosis or liver cancer. CONCLUSIONS: Improving provider-patient communication and integrating treatments for substance abuse and HCV may increase the proportion of IDUs who initiate treatment for HCV infection.

Feasibility of tuberculosis treatment monitoring by video directly observed therapy: a binational pilot study.

BACKGROUND: Although directly observed therapy (DOT) is recommended worldwide for monitoring anti-tuberculosis treatment, transportation and personnel requirements limit its use. OBJECTIVE: To evaluate the feasibility and acceptability of 'video DOT' (VDOT), which allows patients to record and transmit medication ingestion via videos watched remotely by health care providers to document adherence. METHODS: We conducted a single-arm trial among tuberculosis (TB) patients in San Diego, California, USA, (n = 43) and Tijuana, Mexico (n = 9) to represent high- and low-resource settings. Pre-/post-treatment interviews assessed participant characteristics and experiences. Adherence was defined as the proportion of observed doses to expected doses. RESULTS: The mean age was 37 years (range 18-86), 50% were male, and 88% were non-Caucasian. The mean duration of VDOT use was 5.5 months (range 1-11). Adherence was similar in San Diego (93%) and Tijuana (96%). Compared to time on in-person DOT, 92% preferred VDOT, 81% thought VDOT was more confidential, 89% never/rarely had problems recording videos, and 100% would recommend VDOT to others. Seven (13%) participants were returned to in-person DOT and six (12%) additional participants had their phones lost, broken or stolen. CONCLUSIONS: VDOT was feasible and acceptable, with high adherence in both high- and low-resource settings. Efficacy and cost-effectiveness studies are needed.

Phenotypic and genotypic diversity in a multinational sample of drug-resistant Mycobacterium tuberculosis isolates.

OBJECTIVE: To develop and evaluate rapid, molecular-based drug susceptibility testing (DST) for extensively drug-resistant tuberculosis (XDR-TB), we assembled a phenotypically and genotypically diverse collection of Mycobacterium tuberculosis isolates from patients evaluated for drug resistance in four high-burden countries. METHODS: M. tuberculosis isolates from India (n = 111), Moldova (n = 90), the Philippines (n = 96), and South Africa (n = 103) were selected from existing regional and national repositories to maximize phenotypic diversity for resistance to isoniazid, rifampin (RMP), moxifloxacin, ofloxacin, amikacin, kanamycin, and capreomycin. MGIT™ 960 was performed on viable isolates in one laboratory using standardized procedures and drug concentrations. Genetic diversity within drug resistance phenotypes was assessed. RESULTS: Nineteen distinct phenotypes were observed among 400 isolates with complete DST results. Diversity was greatest in the Philippines (14 phenotypes), and least in South Africa (9 phenotypes). Nearly all phenotypes included multiple genotypes. All sites provided isolates resistant to injectables but susceptible to fluoroquinolones. Many patients were taking drugs to which their disease was resistant. DISCUSSION: Diverse phenotypes for XDR-TB-defining drugs, including resistance to fluoroquinolones and/or injectable drugs in RMP-susceptible isolates, indicate that RMP susceptibility does not ensure effectiveness of a standard four-drug regimen. Rapid, low-cost DST assays for first- and second-line drugs are thus needed.

Correlates of HIV infection among young adult short-term injection drug users.

OBJECTIVES: To identify risks associated with HIV infection among young adult short-term injection drug users. METHODS: Current injection drug users, between 18 and 29 years of age, were recruited through street outreach to participate in a cross-sectional survey of HIV prevalence by circumstances of drug injection initiation, HIV-related risk behaviors, and a follow-up to estimate HIV incidence. RESULTS: At enrollment, 33 (14.4%) of 229 participants were HIV-seropositive. Significant bivariate associations with HIV at the time injection drug use was initiated included age less than or equal to 18 years, having receptive anal sex with the person who assisted with initiation, and having two or more 'trainers' before being able to self-inject. Injecting risks positively associated with HIV included cocaine or speedball (heroin and cocaine together) injection versus heroin or amphetamine injection, injecting five or more times per day, daily crack smoking, backloading, sharing needles at peak drug use, and not using a new needle for every injection. Sexual practices associated with HIV included reporting > 100 lifetime sex partners, a history of sexual assault, being gay or bisexual, and trading sex for money or drugs after starting to inject. In a multivariate model, trading anal sex for money or drugs after initiating injection drug use [odds ratio (OR), 14.2; 95% confidence interval (CI) 3.2-62.3], cocaine/speedball injection (OR, 10.3; 95% CI, 2.2-47.9), daily crack smoking (OR, 4.2; 95% CI, 1.7-10.5), and having two or more trainers (OR, 2.6; 95% CI, 1.1 - 5.9) were independently associated with HIV. During 12 months of follow-up, four persons seroconverted for HIV (annual incidence: 2.6%; 95% CI, 1.1 -5.9%) CONCLUSIONS: Among short-term injectors, both sexual and injecting practices were important predictors of HIV infection, indicating that a proportion of HIV infections among young injection drug users can be attributed to sexual transmission. The incidence rate for HIV infection suggests that immediate steps should be taken to prevent new infections among young injection drug users.

Variability of reporting and lack of adherence to consensus guidelines in human T-lymphocyte immunophenotyping reports: results of a case series.

Percentages and absolute counts of CD4+ lymphocytes, as determined by T-lymphocyte immunophenotyping (TLI), are prognostic, as well as diagnostic, of the course of human immunodeficiency virus type 1 infections and are important indicators for initiating Pneumocystis carinii pneumonia prophylaxis and antiretroviral therapy. In December 1990, we requested that a nonrandom sample of 17 laboratories provide us with typical reports of their TLI results from an immunodeficient patient and from a patient whose TLI results were within the laboratory's normal reference ranges. We also searched published literature and documents proposed by professional organizations for recommendations regarding T-lymphocyte testing and reporting. This article compares guidelines for reporting TLI results, as proposed by the National Committee for Clinical Laboratory Standards in Document H42-P, with samples of reports obtained in our case series. Most reports follow some, but not all, of the proposed guidelines. A majority of the laboratories provided interpretations of the results in their reports. We found considerable variation in normal reference ranges. We describe this variation in detail for the CD4+ T-lymphocyte counts and CD4+ T-lymphocyte percentages. This article describes some of the TLI result report forms currently being used and identifies important quality issues in this rapidly expanding area of clinical laboratory testing.

Content and design of laboratory report forms for human immunodeficiency virus type 1 antibody testing.

In a pilot study involving proficiency testing for human immunodeficiency virus, markedly diverse and potentially confusing test report forms were encountered among participating laboratories. Therefore, a comprehensive study of human immunodeficiency virus type 1 report forms was conducted from state-licensed testing laboratories in California. Participants analyzed three serum samples of known human immunodeficiency virus type 1 antibody reactivity and reported their results on forms that they would normally submit to clinicians. Report forms from 84 laboratories were evaluated for content, design, and clarity. Differences were found among commercial, hospital, and public health laboratories. The significance of these findings is discussed. This technique also may be applied to evaluate laboratory report form design and content for other diagnostic test results.

Methods for a model blind proficiency testing system.

The method developed for establishing a blind proficiency testing (PT) system is presented. The Laboratory Assurance Program of the Graduate School of Public Health at San Diego State University is developing and pilot testing innovative strategies that will evaluate and improve the performance of clinical laboratories. To date, a total of 32 laboratories have been incorporated into this program along with 12 counseling and testing sites. From June 1988 to December 1989, five blind PT surveys for human immunodeficiency virus type 1 antibody testing were conducted, representing 306 proficiency specimens entered into the testing system as simulated patient specimens. Despite the difficulties and expense involved, we found the system to be acceptable and to have certain advantages over conventional methods of external testing.

Analytic results of HIV-1 testing using blind proficiency testing.

The use of blind proficiency testing (PT) to examine analytic performance of human immunodeficiency virus type 1 (HIV-1) antibody testing. A total of 32 hospital, blood bank, public health, and commercial laboratories were included in this study. Test sera were introduced as clinical specimens for HIV-1 testing from private practitioners, group practices, clinics, and hospitals in Southern California. A total of 26 laboratories were located throughout California, with six laboratories located in six other states. Results from 306 enzyme immunoassay screening tests and 192 supplemental tests for HIV-1 were reported. Although one positive specimen was reported as indeterminate in almost 30% of results, screening and supplemental testing performances were excellent, with accuracy levels comparable to performance reported on open PT and performance evaluation surveys in the United States. The indeterminate results were attributed to the interpretive criteria used rather than to laboratory errors. Blind PT can be an important tool in improving the quality of total laboratory testing, the usefulness of laboratory results in patient care, and ultimately the health of the public.

Identification of nonanalytic issues in HIV-1 antibody testing using blind proficiency testing.

Blind proficiency testing was used to examine nonanalytic performance indicators for human immunodeficiency virus type 1 (HIV-1) antibody testing. Physician offices, clinics, and hospitals located throughout Southern California submitted simulated patient specimens to laboratories as routine test requests. A total of 32 laboratories were involved during five blind proficiency testing surveys. Turnaround time for a reactive specimen ranged from three to 17 days. Laboratory charges for evaluating a reactive specimen varied depending on the volume of testing, prevalence of reactive specimens, and whether screening and confirmatory tests were billed separately or as a package price. Charges for an enzyme immunoassay screening test plus supplemental tests ranged from $11.75 to $114.50, with a median of $31.00 for 24 laboratories that participated in one of the five surveys. Evaluation of laboratory report content revealed that 37% of the 16 screening reports and 71% of the 14 supplemental reports contained information that was unrelated to the patient results. Evaluation of the testing system documents the need to monitor multiple outcomes of the total laboratory testing process, not just the analytic testing phase.