Point of Care testing (POCT)For

Sexually Transmitted Infections (STI)

Barbara Bewley

Operations ManagerPathology Clinical Services

Pathology Clinical Services

ClinicalHaematology

Immunology

PhysiciansAssistants Diabetes

Endocrinology

Phlebotomy

POCT

OpsManager

POCT for STIs

• What is POCT?• Who oversees POCT?

• Governance

• Who performs POCT? • Hands on staff

• Why POCT?• Benefits

• Why POCT for STIs?• Benefits

• What is available?

POCT - Definition

“… any analytical test performed for a patient bya healthcare professional outside theconventional laboratory.”

“…testing that is performed near or at the siteof the patient with the result leading to possiblechange in the care of the patient.”

POCT Guidelines and Standards

• Management and Use of IVD Point of Care Test Devices– March 2003 DB2002(03)

• Pre POCT implementation - Lab involvement– Clinical need– Equipment choice– Business Case– Clinical Governance– Pro’s and Con’s

POCT Guidelines and Standards

– DB2002(03)

• Management and Organisation– Accountiblity– SOPs, Training, Health and Safety– QA (inc QC,& EQA)– Maintenance, Record Keeping– IT– Adverse Incidents

POCT Guidelines and Standards

• DB2010(02) February 2010– More expansive

• Locations– Wider variety of hospital and community areas

• Range of test examples

– References Strategic Government Papers– Use of Case studies

• Illustrates poor practice• Specific key learning points

POCT Guidelines and Standards

• Ultimate responsibility

–“The laboratory, or the parentorganization of which it is a part,shall ultimately be responsible forensuring that appropriate measures,including internal quality control andparticipation in EQA schemes, arein place to monitor the accuracy andquality of POCT conducted withinthe healthcare organization.”

POCT Management

• Team– Senior Biomedical Scientist – Band 7– Biomedical Scientist – Band 6– Associate Practitioners x 3 – Band 4– Administrative Assistant

• Multidisciplinary• Trust Policies• Procurement control

POCT - Locations and Staff Groups

wardsOut

patients

GPsurgery

A&EOff Site

Pharmacy

OtherHospitals

Consultants

SpR

SHOHO

Medicalstudents

Nurses

Midwives HCAs

ODPs

PAs

Lab staff

RespTechs

Anaesthetists

COPDnurses

Studentnurses

Pharmacists

Practicestaff

Out Reach

POCT – Why?

• Turn Around Time (TAT) for results– Analysis time – Reporting time– Transport

• Benefits– Rapid changes to care and medication– A&E 4 hour target– Prevent unnecessary cancellation of appointments– Captures hard to reach clients

Quality Point of Care Testing

• Right result for• Right investigation on• Right specimen from• Right patient at• Right time in• Right place using• Right reference data at• Right cost (?)

POCT for STIs

• USA (2010)– 30 STI organisms in lead group of reportable

diseases– >19 million new cases per year– Cost of 9.3 – 15.5 million dollars– Lab TAT 2 – 14 days

• Contributed to low pt return rates• Re infection of presenting patients• On going transmission of infection

POCT for STIs

• Ideal POCT for STI– Immediate diagnosis and treatment in a single

visit– Address some of STI control needs

POCT for STIs

• Barriers– Complexity – Time– multiple time driven steps– Difficulty reading results– Interruption of workflow– Unreliability– Invasiveness

POCT for STIs

• The WHO Sexually Transmitted Diseases Diagnostic Initiative coined the term ASSURED to define the criteria for a POCT for STIs in a resource limited setting.

ASSURED – WHO Criteria

• Affordable• Sensitive• Specific• User friendly• Rapid & Robust• Equipment free• DeliveredAn ASSURED test that is less sensitive than a lab test

might result in more infected people receiving treatment

POCT for STIs

• Applicable to other settings:– Access and confidentiality– Community based services– Improve low return rates for results– Reduction in mental stress for returners– Transient populations– Hard to reach communities

• STI’s-– chlamydia, – gonorrhea, – syphilis, – HIV

Current examples of POCT for STIsCurrent examples of POCT for STIs

Future POCT for STIs

• BioMEMS– Microfluidics allowing miniaturisation of

complex reaction processes

• PCR– Smaller equipment & sample size– Faster processing

POCT for STIs

• What is POCT?• defined

• Who oversees POCT?• POC team/appropriate lab

• Who performs POCT?• Clinical staff

• Why POCT?• TAT, quicker changes to care/ medication• improved patient care• Reduction in cancelled appointments

POCT for STIs

• Why POCT for STIs?– Effectively treat more people with STIs

• Single visit diagnosis and treatment initiation• Infection control strategy = risk reduction

• What is available?• Increasing number of manufacturers• Increasing range of products• Remember the WHO ASSURED criteria

– Not lab quality but must meet minimum criteria

Thank you