ANALYTICAL PERFORMANCE

Analytical Specificity

Cross-Reactivity Evaluation of the Oral Genome P. gingivalis Lateral Flow Assay

The assay was challenged with a panel of closely related periodontal pathogens to confirm that a positive result reflects P. gingivalis — and not look-alike bacteria found in the same oral environment.

Oral Genome saliva test kit and lateral flow assay device

HEADLINE RESULT

No cross-reactivity observed

Against every related pathogen tested, up to 1×10⁷ CFU/mL in a saliva matrix.

Confirms the assay is specific to the intended target.

4

Related pathogens challenged

0

Clinically significant cross-reactions

107

Highest challenge concentration

6x

Replicates per condition

WHAT THIS MEANS

Why analytical specificity matters

Saliva is a crowded environment. Dozens of bacterial species live alongside Porphyromonas gingivalis, a keystone pathogen in periodontal disease — and several of them share similar surface structures. A trustworthy test has to tell them apart.

Analytical specificity measures exactly that: whether the test reacts only to its intended target, even when closely related organisms are present at high concentrations. Strong specificity means fewer false positives and greater confidence in every result a clinician acts on.

STUDY DESIGN

How the assay was challenged

The panel was deliberately chosen for difficulty: closely related Gram-negative anaerobic periodontal pathogens with lipopolysaccharide (LPS) or surface-antigen similarity to P. gingivalis — the organisms most likely to trigger a false signal.

Porphyromonas endodontalis

Gram statusGram-negative
LPS / LOSYes
Periodontal pathogenYes

Prevotella intermedia

Gram statusGram-negative
LPS / LOSYes
Periodontal pathogenYes

Tannerella forsythia

Gram statusGram-negative
LPS / LOSYes (atypical)
Periodontal pathogenYes

Treponema denticola

Gram statusSpirochete (Gram-negative-like)
LPS / LOSLOS/LPS-like
Periodontal pathogenYes

Saliva matrix

Each organism was spiked into pooled negative saliva to reflect real sample conditions.

3 concentrations

High 1×107, medium 1×106, and low 1×105 CFU/mL — up to supraphysiologic loads.

Full controls

P. gingivalis positive controls across the same range and negative saliva controls, all in six replicates.

Test-organism concentrations were standardized by optical-density measurement against a reference calibration. Study conducted at an independent third-party laboratory.

RESULTS

Specific to the target, across the board

The P. gingivalis positive controls produced clear, concentration-dependent signal. None of the related pathogens produced a clinically significant test line at the concentrations evaluated.

Prevotella intermedia

Tested to 1×107 CFU/mL

No cross-reactivity

Tannerella forsythia

Tested to 1×107 CFU/mL

No cross-reactivity

Treponema denticola

Tested to 1×107 CFU/mL

No cross-reactivity

Porphyromonas endodontalis

Tested to 1×106 CFU/mL

No cross-reactivitySee note ↓

CONCLUSION

Excellent analytical specificity for
P. gingivalis

No analytical cross-reactivity was observed for the related periodontal pathogens tested, up to the concentrations below.

  • Cross-reactant

    Prevotella intermedia

    No cross-reactivity up to

    1×107 CFU/mL

  • Cross-reactant

    Treponema denticola

    No cross-reactivity up to

    1×107 CFU/mL

  • Cross-reactant

    Tannerella forsythia

    No cross-reactivity up to

    1×107 CFU/mL

  • Cross-reactant

    Porphyromonas endodontalis

    No cross-reactivity up to

    1×106 CFU/mL

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