The Problem 25/09/2018. Hydrosense 1. Agenda

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1 Using Innovation & Proven Technologies to Challenge Conventional Legionella Testing Paradigms & Save Lives Greg Rankin, CEO, Hydrosense World Aquatic Health Conference 11 th October 2018 Agenda Overview of The Problem Legionella and Legionnaires disease The Role of Testing Traditional Testing Methods An Overview Hydrosense The Role of Rapid Testing The Problem Hydrosense 1

2 The History of Legionella Pneumophila The Bellevue-Stratford Hotel, Philadelphia July 21 24th th Convention of the American Legion was held at the hotel July 27 th 1976 the first death was reported 221 pneumonia cases (34 deaths) but cause was a mystery January 1977 Dr Joseph McDade of CDC isolated bacteria It was also isolated from the hotel s cooling tower water 72 cases were patients that didn t attend the convention Thus the realization came that droplets containing bacteria and inhalation of them in & around the hotel was the cause Named: Legionella pneumophila; Condition: Legionnaires disease Documentary Legionella Over 50 species and 70 serogroups identified Only around half of species cause any disease, much of it non serious Legionella Longbeachae notable dangerous species found in soil Most virulent species are water based Most dangerous of all waterborne species is Legionella pneumophila Most dangerous serogroup of Legionella pneumophila is serogroup 1 Legionella pneumophila serogroup 1 responsible for vast majority of deaths from Legionnaires disease globally (where data exists) Legionella Pneumophila Ubiquitous in most fresh water sources on earth Rivers, ponds, lakes etc. Detected in up to 40% of freshwater environments by culture and up to 80% by PCR Gram negative, rod shaped, pleomorphic parasite of amoeba Stains poorly due unique lipopolysaccharide content (antigen component) in outer cell membrane Hard to detect and to eradicate Capable of remaining in dormant Viable But Non Culturable state for long periods Often resident in biofilm so can be resistant to biocides Generally resilient/adaptive to environment 15 Serogroups of L. p and over 50 other species of Legionella bacteria Hydrosense 2

3 Legionella life cycle Ideal Conditions for Legionella Biofilms or Sediments Temperature Cell growth between 77 F 108 F (20 C to 45 C) Peak growth temperature ~ 96 F (36 C) Cell multiplication reduced but cells still viable 113 F 120 F (45 C to 49 C) Cells start to die above above 122 F (50 C) Speed of cell death increases as temperature increases. Above 158 F (70 C) cells are killed quickly. Amoeba present Nutrients (including iron and L cysteine) ~ Neutral ph Low flow (or dead legs in the system) Route of Infection Inhalation of aerosols <5 µm aerosols can enter alveoli in lungs Legionella bacteria survive 3 4 hrs in aerosols at relative humidity of 65% Cooling tower bacteria has been shown to spread many kilometers Aerosols created by atomisation or water impacting surfaces Minimal evidence of person to person spread or by drinking water Hydrosense 3

4 Some Confirmed Sources Spas/Jacuzzis Showers/taps Ornamental Fountains Water Sprinklers Clinical Humidifiers Drilling/Grinding Machines Swimming Pools Car Washes Ice Making Machines WCs Dental Equipment Misting Machines Symptoms of Legionnaires Disease 2 10 day incubation period Typically presents as pneumonia Fever (>39 C) in 70% Cough in 75% Sputum production 45% Confusion 45% Myalgia 38% Diarrhoea 33% Headache 32% Legionnaires Disease Characteristics Risk Groups >50 years old Smokers Hospital patients Chronic Medical Conditions (particularly immunosupression) Men (2 3x more susceptible) 10 15% patients die More long term health effects 1 Fatigue (75% of patients) Neurologic symptoms (66%) Neuromuscular symptoms (63%) HRQL was impaired in 7 of the 8 PTSD (15%) LD Cases 2015: 7,034 (EU), ~6000 (US) Underdiagnosis globally, likely very significant HEALTHY ADMISSION DAY 4 1 YEAR 7 YEARS Radiography Source: Legionella Infections, Bartlett, Christopher L.R., Macrae, Alastair D., Macfarlane, John T, ISBN 10: Follow up study with 122 survivors in Nl : Hydrosense 4

5 Epidemiology Of Legionellosis Legionellosis Legionellosis is the term used to describe all diseases caused by Legionella bacteria (>50 species) 95% of Legionellosis cases are Legionnaires Disease L. p Serogroup 1 causes ~85% of legionellosis. Legionella Longbeachae is also pathogenic. This bacteria is not water based (typically found in compost.) Other Legionellosis illnesses include Pontiac Fever and Lochgoilhead fever which typically self resolve in 2 3 days. Legionnaires' disease caused by LP Serogroup 1 Legionnaires' disease caused by other Legionellae Other Legionellosis Illnesses Legionella A growing problem in the EU/EEA Source: disease europe 2014.pdf Legionella A growing problem in the US Source: reporting.html Hydrosense 5

6 Legionella A growing problem in the US Source: reporting.html Source: disease europe 2014.pdf Why is Legionnaires Disease growing? Susceptibility Better Diagnosis Increase in auto immune diseases Increase in immune suppressing medications Aging populations Better technology Medical practitioners better at spotting LD symptoms Vs other pneumonia Environmental Climate Change Warmer weather Wetter conditions Research What does some of the latest research say about Legionnaires disease in pools and spas? Hydrosense 6

7 Research Treated Recreational Water Outbreaks 500 Outbreaks associated with Treated Recreational Water in US Most frequent outbreak setting hotels 20% of 13,834 inspections of public hot tubs/spas identified improper water treatment [16 jurisdictions, 2013] Legionella can be protected in biofilm and rapidly amplify when disinfection concentrations subside. Source: Research Legionellosis in Recreational Waters 42 Events Reviewed Private Houses, Public/Hotels, Hot Spring/Thermals Spas 29 Fatalities (69% chance of fatality per outbreak) 459 Legionnaires Disease Cases (~11 cases of LD per outbreak) Public centres/hotels highest number of events (22), cases (744), and deaths (16) Where LD Diagnosis undertaken over 18 Events ALL fatalities involved Legionella pneumophila Serogroup 1 Source: Cases_and_Outbreaks_in_Swimming_Pools_Spa_Pools_and_Similar_Environments Research Outbreaks of LD & PF Confirmed and Probable LD Cases in Pools and Spas Top 3 source of disease after Cooling Towers/Aircon and Potable Water Systems 433 Pontiac Fever Cases in Pools and Spas Number one source followed by Cooling Towers Source: r_ /links/5b1b188e0f7e9b68b429e736/Outbreaks of Legionnaires Disease and Pontiac Fever pdf Hydrosense 7

8 Testing Why test? Legionella is practically ubiquitous Legionella is very resilient VBNC dormant forms when shocked Hides in biofilm so can be resistant to biocides and heat treatments Total eradication / complete sterility impractical Typical treatments and risk management techniques are not 100% effective Therefore testing is an absolute necessity to MANAGE RISK Source: Causes of Outbreaks in North America ( ) Why test? More than one of the above in 48% of cases Unmanaged external changes 35% Process Failures 65% Human Errors 52% Equipment Failures 35% Garrison LE, Kunz JM, Cooley LA, et al. Vital Signs: Deficiencies in Environmental Control Identified in Outbreaks of Legionnaires Disease North America, MMWR 2016;65: DOI: Hydrosense 8

9 Testing Lab Culture Lab Culture Testing The original method for analytical methods to detect Legionella is lab culture testing Culture methods are a good tool for the quantification of serogroups of L. pneumophila and species, but require days to return a result The recovery rate of the lab test is typically much lower than Hydrosense or PCR testing Part of every regulatory compliance framework Sometimes referred to as the Gold standard of testing. This is an historical phrase which is now very hard to justify due to its significant shortcomings. Lab Culture Testing Many methods in use including: ISO CDC Standard Methods SM9260J Which is best for separating out Legionella from non Legionella bacteria? Which media does your lab use? Do each of the media types perform the same way? Hydrosense 9

10 Culture testing The Gold Standard? Recovery rates vary from ~30% to ~80% ISO Water quality Enumeration of Legionella (ISO 11731:2017) 1 Multi country intralaboratory trial recovery rate of > 64% Why so low? Legionella complex lifecycle & parasite, yet lab culture does not provide host Some lifecycle stages are not replicative Other bacteria can dominate so acid and heat treatments performed on sample Sources: 1 : Page 29 Table H.1 Culture testing The Gold Standard? Viable But Non Culturable (VBNC) bacteria are dangerous 1 Very slow 10 to 14 days time to a result is too slow for many applications Decorative fountain in lobby of a hotel Underused hotel room that needs to be used imminently ANY location where there is concern on water safety Missed maintenance/duty holder absent for period of time Visual or other evidence (e.g. biofilm buildup) etc. Any location where your customer won t want to get that call 2 weeks later! 1 : Lab Culture Testing A view of the past September Type equation here. Hydrosense 10

11 Legionella life cycle Effects on testing The motile phase of Legionella pneumophila is not ready to replicate it is seeking an amoeba (or lung cell!) This is one of the reasons that lab culture tests have lower recovery rates Legionella antigen can be detected in any phase of Legionella s lifecycle This enables detecting the bacterium when it is an immediate danger to humans. Testing PCR PCR Testing Polymerase Chain Reaction Testing Method of amplifying DNA Heating to denature or split the DNA into two single strands Use enzyme to synthesize two new strands using the split pair Results in duplication of original DNA Can be done 30+ times Millions of copies in hours Amplified Legionella DNA is then detected (variety of methods) Lab based, expertise required, not easily scalable to many tests Fast, but ship to lab then report typically means ~2 days before result is available Hydrosense 11

12 PCR Testing As with Lab Culture testing care must be taken with the sample Sodium thiosulphate used to neutralize chlorine Sample must not experience excessive temperatures High recovery rate ~90% but some studies have shown high false positives when compared with Lab Culture tests Can get false positives from Biocides or other contaminants in the water. Important to have water types screened before relying on results Can detect VBNC Testing Antigen Testing Antigen Test Detects: Legionella pneumophila SG1 Method: Lateral Flow Immunochromatographic Assay (LFICA) PROVEN technology used widely in clinical setting Adapted to be able to cope with wide variety of water types, biocides and contaminants Time for result: 25 Minutes (<10 mins filtration) LOD: 100 CFU/L, 1000 CFU/L, 10,000 CFU/L or 100,000 CFU/L Recovery Rate: Greater than Lab Culture at 80% Where: On site Immediate, so minimises risk Anyone can take test with minimal training Detects dangerous VBNC bacteria Hydrosense 12

13 Recovery Rates Antigen Test Vs. Culture International Water Conference Paper Presented with Nalco at IWC 182 Samples Spiked with varying doses of Legionella pneumophila SG1 Lab Culture 101 POSITIVES 81 NEGATIVES 55% Accuracy/Recovery Rate Hydrosense 146 POSITIVES 36 NEGATIVES >80% Accuracy/Recovery Rate Note: Many of the negatives were likely below the Limit of Detection for the Hydrosense test 100CFU/L Hydrosense 13

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16 App and Portal AIM - Use technology to accelerate decision to protect people Records batch number, date, time, user, test location and result information Test schedules to monitor testing programs Secure connectivity to Hydrosense Portal Real time tracking and monitoring of results Test Result Alerts immediate communication with Duty managers SMS Stored report inc. photo of test Minimises Time to Decision Reader App Android and ios Returns to the user a score of "0" for no Legionella detected. Returns a Hazard Index (HI) value of "1 10" depending on quantity of Legionella antigen HI values mapped to CFU/ml values from experiments on precise Legionella counts (via lenticules) Produce conformance reports from stored data Hydrosense 16

17 Reader Benefits Summary Schedule alerts/reminders Immediate notification of positive results to Duty Holders Create Audit Trail and certificates Turn visual readings into quantitative results Give confidence to inexperienced test users, removing doubt Ability to integrate data captured with water management service desks Models for Use of Hydrosense Routine monitoring of water systems Immediate need to assess risk Part of comprehensive risk assessment Environments with no lab access Rapid identification of likely source of outbreaks Legionella is a serious health problem. Legionella pneumophila serogroup 1 by far the most virulent and deadly. It is clearly a growing problem in US and EU/EEA Summary It cannot be easily eradicated or controlled testing is necessary Lab Culture testing s deficiencies increasingly understood Slow Completely Low recovery misses deadly rate/accuracy VBNC Legionella Should NOT be used by itself for Risk Mgt. Hydrosense 17

18 Recreational Water a significant Risk area for Legionella Particularly Public or Hotel Hot Tubs, Spas and Pools Rapid Antigen Test Method Useful For Immediate Call to Action Summary Simple for any member of staff or duty holder to use Time to Decision Reduced from Over 2 weeks to ~30 minutes Fast High recovery rate/accuracy Detects VBNC Legionella Key Risk Management Tool Questions? Contact greg.rankin@albagaia.com legionella.com Hydrosense 18