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Point of Care Diagnostics for Iron Deficiency in pre-menopausal women undergoing surgery - testing the efficacy of saliva sampling versus blood sampling

Point of Care Diagnostics for Iron Deficiency in pre-menopausal women undergoing surgery - testing the efficacy of saliva sampling versus blood sampling

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000701325
Acronym
POCID
Enrollment
150
Registered
2026-06-11
Start date
2022-12-12
Completion date
2023-12-05
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aimed to explore any correlation between salivary and serum ferritin in 150 women undergoing elective surgery, to evaluate the feasibility of using salivary ferritin as a non-invasive biomarker for iron deficiency. Participants provided a fasted morning saliva sample and blood sample prior to their surgery. It was hypothesised that ferritin levels in saliva would accurately reflect serum ferritin levels.

Interventions

Saliva ferritin levels will be collected from all participants using a fasted, morning saliva sample during the patient's admission prior to surgery. The saliva collection kits are commercially available kits from Salimetrics. Kits will be provided to patients in their hospital cubicle by research coordinators/ research nurses. Participants will use the ‘passive drool method’ to provide their sample which is anticipated to take up to five minutes. They will be shown an instructional video (appro

Saliva ferritin levels will be collected from all participants using a fasted, morning saliva sample during the patient's admission prior to surgery. The saliva collection kits are commercially available kits from Salimetrics. Kits will be provided to patients in their hospital cubicle by research coordinators/ research nurses. Participants will use the ‘passive drool method’ to provide their sample which is anticipated to take up to five minutes. They will be shown an instructional video (approx four minutes in length) and instructed to allow saliva to collect in their mouth. They will then lean forward and allow the saliva to drool into the saliva collection kit. Participants will be instructed not to spit or force the saliva out of their mouth to avoid foaming. A total of 0.5mL minimum is required for analysis. Following collection of the sample, research staff will visually inspect the sample to confirm that the minimum sample was required and to check that there is an acceptable amount of foam in the sample. The sample will then be immediately transported and stored in a -80 degree Celsius freezer in the Barwon Health laboratory. Samples will be collected intermittently or at the end of the study, as arranged with the CSIRO. Samples will be further processed (e.g. clarified by centrifugation) and analysed for ferritin levels by an established method. The assay kit will be the Human Ferritin ELISA Kit (ab108837) supplied by Abcam. The same cut offs for serum ferritin levels will be used to classify patients as either iron deficient, normal or elevated with regard to their salivary levels of ferritin (Iron Deficiency: 220 µg/L).

Sponsors

Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

• Female • Aged 16-60 years • Undergoing elective surgery at University Hospital Geelong

Exclusion criteria

• Refusal of blood and/ or saliva sample • Non-English Speaking Background or Interpreter required • Inability of saliva sample to be collected in the morning prior to eating or drinking (non-fasted patient) or stored for less than 2 hours in a refrigerator prior to arrival in hospital. • Recent dental work (within the last week). • Currently undergoing or received medical procedures including radiation (e.g. current chemotherapy or isotope procedures pre-operatively on the day of surgery). • Diagnosed chronic degenerative inflammatory condition (i.e. rheumatoid arthritis, inflammatory bowel disease and metastatic cancer). • Post-menopausal or have had a hysterectomy

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026