A Model of Shared Mycobacteriology Testing Services: Lessons Learned

Objective

The need for public health laboratories (PHLs) to prioritize resources has led to increased interest in sharing diagnostic services. To address this concept for tuberculosis (TB) testing, the New York State Department of Health Wadsworth Center and the Rhode Island State Health Laboratories assessed the feasibility of shared services for the detection and characterization of Mycobacterium tuberculosis complex (MTBC).

Methods

We assessed multiple aspects of shared services including shipping, testing, reporting, and cost. Rhode Island State Health Laboratories shipped MTBC-positive specimens and isolates to Wadsworth Center. Average turnaround times were calculated and cost analysis was performed.

Results

Testing turnaround times were similar at both PHLs; however, the availability of conventional drug susceptibility testing (DST) results for Rhode Island primary specimens and isolates were extended by approximately four days of shipping time. An extended molecular testing panel was performed on every specimen submitted from Rhode Island State Health Laboratories to Wadsworth Center, and the total cost per specimen at Wadsworth Center was $177.12 less than at Rhode Island State Health Laboratories, plus shipping. Following a mid-study review, Wadsworth Center provided testing turnaround times for detection (same day), species determination of MTBC (same day), and molecular DST (2.5 days).

Conclusion

The collaboration between Wadsworth Center and Rhode Island State Health Laboratories to assess shared services of TB testing highlighted a successful model that may serve as a guideline for other PHLs. The provision of additional rapid testing at a lower cost demonstrated in this study could potentially improve patient management and result in significant cost and resource savings if used in similar models across the country.Public health laboratories (PHLs) are essential for disease prevention and control. They serve as a first line of defense by rapidly recognizing and averting the spread of communicable diseases. In addition, they play a critical role in providing specialized tests for low-incidence, high-risk diseases, such as tuberculosis (TB), rabies, and botulism.¹ Due to recent economic constraints, many PHLs have suffered financial pressures, including budget and staffing cuts. In some cases, PHLs have reduced or eliminated certain tests, creating a potential risk to the public''s health. As an alternative to the discontinuation of services, one suggested approach was the investigation of shared services with other PHLs in different jurisdictions through testing directories and pilot projects with assistance and support from the Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL).^2,3TB, which is caused by the bacteria Mycobacterium tuberculosis, is a disease for which PHLs play an important role by providing diagnostics that contribute to prevention. Despite an overall decline in cases, TB continues to be a significant burden on social, public health, and economic systems in the United States.⁴ Maintaining a comprehensive and efficient laboratory system is critical to the continued decline of TB rates and overall prevention and control of TB in the United States. However, providing comprehensive TB testing services is becoming increasingly expensive per case identified. Additionally, retaining technical proficiency remains a challenge, especially as many experienced personnel are lost to retirement and are difficult to replace.⁵In 2013, a total of 9,582 new TB cases were reported in the United States, with an incidence rate of 3.0 cases per 100,000 population. Only four states reported more than 500 cases of TB: California, Texas, New York, and Florida, accounting for half of all TB cases in the United States. The TB incidence rate in New York State (NYS) is 4.4 per 100,000 population.⁴ The overall number of TB cases in NYS has decreased slightly over time, while the number of drug-resistant TB (DR TB) cases has remained steady during the past five years. Additionally, the percentage of multidrug-resistant TB (MDR TB) cases in NYS has increased from 1.3% to 3.6% during the past five years.⁶ In contrast, the TB incidence rate in Rhode Island is 2.6 per 100,000 population, and the overall number of TB cases has remained constant; DR TB and MDR TB cases in Rhode Island are rare.^4,7 Given the low number of TB-positive specimens received each year in Rhode Island State Health Laboratories, developing an extensive, increasingly molecular-based, testing program for TB may not be cost effective. In contrast, a high proportion of specimens received each year by the NYS Department of Health Wadsworth Center are Mycobacterium tuberculosis complex (MTBC) positive, including DR TB and MDR TB cases, and an extensive testing program has been implemented.We assessed the feasibility of shared services for the detection and characterization of MTBC between Wadsworth Center and Rhode Island State Health Laboratories during a 10-month time period. Multiple aspects critical to the implementation of shared services were examined, including shipping, testing, reporting, and cost. During this project, Wadsworth Center provided services to Rhode Island State Health Laboratories for rapid detection of MTBC, MTBC species identification, rapid detection of mutations associated with rifampin and isoniazid resistance, and conventional drug susceptibility testing (DST). Importantly, this partnership allowed Wadsworth Center to assess its ability to share its extended testing capabilities with another PHL, determine if the additional services provided were beneficial to patient treatment and outcomes, and identify any potential issues with this testing approach.     

Alcohol policy impact on young risky drinkers and their support for proposed measures

Objective: To explore the impacts of existing policies on young Australian risky drinkers' access to alcohol and to gauge their support for proposed alcohol measures. Methods: The 16–19 year old participants were recruited from three Australian states using non‐random convenience sampling, for either a face‐to‐face or online quantitative survey (N=958). The sample was deliberately selected to represent drinkers whose consumption placed them in the riskiest drinking 20–25% of their age bracket. Results: Half (49%) the sample who were younger than the Australian legal purchase age reported it was ‘easy’ to buy alcohol from bottle stores, and 75% of those who had tried to purchase alcohol, said it was ‘easy’ the last time they tried. Half of those under 18, who had attempted to enter a licensed venue, reported they did not have their identification checked last time they gained access. Ninety per cent of all respondents drank within a private location at their last risky drinking session. Sixty‐five per cent supported ‘increasing the price of [alcohol by 20¢] a standard drink if the extra 20¢ was used to support prevention and treatment of alcohol problems'. Conclusions: Age‐ or intoxication‐based restrictions to alcohol were commonly bypassed. Implications: Point‐of‐sale alcohol controls require improvement to prevent under age access. Given that a significant proportion of drinking occasions for those under 18 were in private premises, prevention strategies need to target these locations. There were diverse levels of support for strategies to reduce harm, including potential community backing for an evidence‐based proposed price policy.     

An immunochromatographic dipstick as an alternate for monitoring of heroin metabolites in urine samples

Heroin use and addiction pose serious risks and side effects due to overdose. Quantification of heroin in biological samples is challenging due to rapid deacetylation of heroin to its active metabolites. In this study, we report the quantification of metabolic degradation of heroin by-products in biological urine samples. The presence of the drug was monitored after oral administration of heroin at different time intervals. Various biophysical techniques, such as high performance liquid chromatography (HPLC) and mass spectrometry (MS) were used to evaluate the presence of the drug. A competitive fluorescence based immunoassay was developed with a limit of detection (LOD) up to 0.01 ng mL⁻¹ and the IC₅₀ value was 0.1 ng mL⁻¹, while the dipstick assay shows a LOD up to 5 ng mL⁻¹. Rapid detection of narcotic drugs was carried out for biological urine samples collected at various time points. Validation of the developed dipstick was carried out for the standard as well as the spiked urine samples by fluorescence based immunoassay (FIA), using anti-morphine antibodies. A strong correlation (R = 0.94) was obtained between the developed dipstick and FIA assay for biological urine samples collected at various time points. The developed immunochromatographic dipstick is highly sensitive, field applicable and cost effective, and can serve as a first choice for the monitoring of narcotic drugs in blood, urine and saliva in drug addicts and athletes.

Pathway of heroin degradation post oral administration in mice.     

Anxiety and outcome expectations predict the white-coat effect

OBJECTIVE: To determine whether elevated clinic blood pressure compared with daytime ambulatory blood pressure, referred to as the white-coat effect, is associated with anxiety and increased blood pressure expectancy in the doctor's office. METHODS: The 24-h ambulatory blood pressure measurements and physicians' blood pressure measurements were obtained in 226 normotensive and hypertensive study participants. Anxiety levels were assessed multiple times during the clinic visit using a Visual Analog Scale. Participants' expectations regarding the clinic visit were assessed using a six-item scale (Expectations of Outcomes Scale). The white-coat effect was computed as the difference between the mean clinic blood pressure and the mean daytime ambulatory blood pressure. Multiple regression analysis was performed to examine the association between anxiety, outcome expectations and the white-coat effect, adjusting for age, sex, and ambulatory blood pressure level. RESULTS: As predicted, outcome expectations and anxiety during the clinic visit were significantly associated with the white-coat effect. Results of the regression analysis indicated that only expectancy had an independent effect on the systolic white-coat effect; however, both anxiety and expectancy had independent effects on the diastolic white-coat effect. CONCLUSION: Our results provide empirical support to the hypothesis that anxiety and blood pressure expectancy may elevate clinic blood pressure.     

'Coumadin ridge' in the left atrium demonstrated on three dimensional transthoracic echocardiography.

An echogenic band like structure was seen in the left atrium on two dimensional transthoracic echocardiography (2D TTE). Full volume three dimensional (3D) TTE and colour Doppler established the surrounding anatomical landmarks, and demonstrated the absence of obstruction related to this band. 3D TTE confirmed that this band like structure was consistent with the ridge between the left atrial appendage and left superior pulmonary vein ('warfarin/coumadin ridge').     

Non-oxidative metabolism of ethanol by rat pancreatic acini.

BACKGROUND: The pathogenesis of alcoholic pancreatitis may involve the metabolism of ethanol (via oxidative and non-oxidative pathways) within the pancreas. The aims of this study were to determine the rate of non-oxidative metabolism in isolated rat pancreatic acini and to compare this to the rate of ethanol oxidation. METHODS: Pancreatic acini were isolated from male Sprague-Dawley rats and incubated with (14)C-ethanol. Radiolabelled fatty acid ethyl esters (non-oxidative metabolites) were isolated from lipid extracts by thin-layer chromatography. Radiolabelled acetate (oxidative metabolite) was isolated from the incubation medium by ion-exchange chromatography. RESULTS: Non-oxidative metabolism by isolated pancreatic acini was demonstrated. At 50 and 100 mmol/l ethanol, fatty acid ethyl ester concentrations were 49.6 +/- 13.3 and 199 +/- 93 micromol/l, respectively. These levels have previously been shown to result in tissue injury. Non-oxidative metabolism was increased 9-fold by addition of oleic acid and inhibited by the lipase inhibitor, tetrahydrolipstatin, by 91.05 +/- 1.99%. The rate of oxidative metabolism was 21-fold higher than that of non-oxidative metabolism. CONCLUSIONS: Intact pancreatic cells metabolize ethanol by the non-oxidative pathway, generating fatty acid ethyl esters at a rate sufficient to cause pancreatic damage. Oxidative metabolism of ethanol occurs at a much higher rate and may also play a role in pancreatitis.     

Socially marketed insecticide-treated nets improve malaria and anaemia in pregnancy in southern Tanzania

OBJECTIVES: To study the uptake of socially marketed insecticide-treated nets (ITNs) and their impact on malaria and anaemia in pregnancy; and to report on a discount voucher system which aimed to increase coverage in pregnancy. METHODS: A 12-month cross-sectional study of women in the second or third trimester of pregnancy. ITN use and other factors were assessed by questionnaire and a blood sample taken for malaria parasitaemia and anaemia. 'Non-users' of ITNs included both women not using any net and women using untreated nets. RESULTS: Fifty three per cent of pregnant women used ITNs. Women aged 15-19, primigravidae, unmarried women, and those with no access to cash had the lowest ITN use. Fewer ITN users were positive for malaria than ITN non-users (25 vs. 33%: P=0.06), and the protective efficacy (PE) for parasitaemia was 23% (CI 2-41). Multiparous ITN users had a twofold decrease in parasite density compared with multiparous non-ITN users (625 parasites/microl vs. 1173 parasited/microl: P=0.01). Fewer ITN users were anaemic (Hb < 11 g/dl) than ITN non-users (72 vs. 82%: P=0.01). ITNs had a PE of 12% (CI 2-21) against mild anaemia and a PE of 38% (CI 4-60) against severe anaemia (Hb < 8 g/dl). There was a trend in the prevalence of severe, mild and no anaemia, and of high density, low density and no malaria infection by ITN status. Recently treated nets were most effective at preventing malaria and anaemia (prevalence of mild anaemia was 68% compared with 82% for those without nets (P=0.002); prevalence of malaria was 22% compared with 33% for those without nets (P=0.02). Knowledge and reported use of the discount voucher system were low. Further qualitative research is ongoing. CONCLUSIONS: A modest impact of ITNs on pregnancy malaria and anaemia was shown in our high malaria transmission setting. The development of ITN programmes for malaria control should include pregnant women as a specific target group.     

Physical and pH properties of gastroesophagopharyngeal refluxate: a 24-hour simultaneous ambulatory impedance and pH monitoring study

OBJECTIVES: Frequency occurrence of nonacidic and nonliquid reflux events in the pharynx has not been systematically studied. The aim of the present study was to characterize the physical (liquid, gas, and mixed gas/liquid) and pH properties of the gastroesophagopharyngeal refluxate. METHODS: We performed a total of 31 24-h simultaneous ambulatory pharyngoesophageal impedance and pH recordings in 11 GERD patients, 10 patients with reflux-attributed laryngitis, and 10 healthy controls. RESULTS: On average, the total number of reflux events (all kinds) in the pharynx was less than half of that in the proximal esophagus (18 +/- 4 vs 50 +/- 4, p < 0.01). Most of the pharyngeal reflux events were gas events and were observed in all three studied groups. Prevalence of these gas reflux events ranged between 0 and 74. The number of gas reflux events accompanied by a minor pH drop in laryngitis patients (1 (0-36)) was significantly higher than those in GERD and controls (0 (0-2) and 0 (0-1), respectively, p < 0.05). There was no significant difference in the number of nonacidic gas reflux events among the three groups (GERD: 10 (2-57), laryngitis: 11.5 (0-51), controls: 10.5 (0-27)). Impedance recording identified a total number of 566 events in the pharynx. Of these, a total of 563 events were compatible with gas reflux events, 101 events were accompanied by minor drops in intrapharyngeal pH, whereas 460 events were not accompanied by any pharyngeal pH change. CONCLUSIONS: Concurrent impedance and pH recordings detect significantly more events qualifying as reflux in the pharynx than pH recordings alone. A substantial majority of these events are gaseous refluxes both with and without minor pH drops. Gas reflux events with weak acidity appear to be more common among patients with reflux-attributed laryngeal lesions compared to GERD patients and controls.