Agency:Medicalservicesadvisorycommittee(MSAC) Australian Governmentdepartment of Health

Title:OstaseImmunoassayfortheMassMeasurementofSerumBoneAlkaline

Phosphatase,May2003

Agency:MedicalServicesAdvisoryCommittee(MSAC) Australian GovernmentDepartment of Health andAgeing

GPO Box 9848 Canberra ACT 2601 Australiahttp://www.msac.gov.au

Reference:MSACapplication1044. AssessmentreportISBN0 64282360 X

Ostase isanin-vitrodiagnosticlaboratorytestused inthemass measurementof bone alkalinephosphatase(BALP)inhumansera.

Aim

Toassess thesafety,effectivenessandcosteffectivenessof theOstasediagnosticlaboratory tests(Tandem-ROstase, Tandem-MPOstaseandAccessOstase)inthediagnosisand monitoringof patientswith,or suspectedof having,metabolicbonedisease,andthe circumstancesunderwhichpublicfundingshouldbesupportedfor theservice.The indicationsaddressedwerePaget'sdiseaseofbone,renalosteodystrophy,bonemetastases fromprostatecancer,andosteoporosis.

Conclusionsandresults

Safety

Thereisno safetyrisk topatientsandtheusualriskstolaboratorystaffassociatedwiththe handlingof bloodandotherbodilyfluids.

Effectiveness

PerformancecharacteristicsAreasonablystrongcorrelationwas reportedbetweenthethree Ostase testsandbetweenOstaseandelectrophoresis.No informationisavailableon the sensitivityandspecificityof theOstase testscomparedwitheachotheror electrophoresis. Cross-reactivityof about10%was reportedwithalkalinephosphatase(AP) of liverorigin, whichmaylimitthetest'sutilityinpatientswithsignificantlyelevatedliverAP.

Diagnosticaccuracy Ostaseappearstohavethepotentialtobeusefulasasupplementary testinthediagnosisof Paget'sdisease,differentiationofrenalosteodystrophy,diagnosisof prostatecancerbonemetastases,andmonitoringtreatmentinwomenwithosteoporosis. However, supportiveevidenceof diagnosticaccuracyisrequiredfromlargermore representativestudies.

Impacton clinicaldecisionmakingandhealthoutcomesNo studieswerefound that specificallyaddressedthe clinicalvalueofBALPtestingbyOstase.

Cost-effectiveness

An economicanalysisof theroleof Ostasecouldnotbeperformed.

Recommendations

MSAC recommendedagainstpublicfundingasthereis currentlyinsufficientevidence of theeffectivenessandcost-effectivenessofOstase inthediagnosisandmonitoringof treatmentintheindicationsreviewed.

Method

A systematicliteraturereviewaddressingthesafetyandeffectivenessofOstasein

patientswithor suspectedof havingPaget'sdiseaseofbone,renalosteodystrophy,bone metastasesfromprostatecancerandosteoporosis,andcost-effectivenessinpatients

withosteoporosis was conductedbytheNHMRC ClinicalTrialsCentre.Theliterature was searchedfrom1996 toFebruary2003 usingbiomedicalelectronicdatabases,the Internetandinternationalhealthtechnologyassessmentorganisationwebsites.

Produced byDr Kristina Coleman (epidemiologist), NHMRC CTC, Australia.