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PCR · bacterial, fungal, viral targets · +$125

Is there bacterial, fungal or viral material in the vial?

Nucleic acid is extracted from the dissolved sample and amplified against a panel of targets. It finds the genetic signature of contamination at very low levels, whether or not the organism is still alive. It is a screen, and we call it one.

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PCR SCREEN · VL-2026-[00404a]ALL TARGETS ND
TargetCtCall
Bacterial 16S rRNA—Not detected
Fungal ITS—Not detected
Viral panel [list]—Not detected
Internal control27.1Valid ✓
Illustrative readout — real lot spectra replace this when the registry opens.

How it works

  1. 01
    Extract
    DNA and RNA are pulled from an aliquot of the reconstituted sample with a kit that includes an extraction control.
  2. 02
    Amplify
    Separate reactions target the bacterial 16S rRNA gene, the fungal ITS region, and a viral panel [list to be published with the validated method]. RNA targets go through reverse transcription first.
  3. 03
    Read Ct
    Each reaction reports a cycle threshold. A valid internal control and a Ct below the cutoff is "detected"; no amplification is "not detected".
  4. 04
    Rule out contamination
    No-template controls run on every plate. A detection in the blank invalidates the run.

What the result means — and what it doesn't

Not detected means no target amplified above the cutoff with valid controls. Detected names the target and the Ct. PCR finds nucleic acid, so it can flag dead organisms and cannot prove a vial is sterile. The screen is an add-on and is not part of the seal.

We will not say: "sterile", "sterility tested", or USP <71>. Sterility testing is a culture-based test on a batch; this is a molecular screen on one vial.

Why another lab might report a different number

  • Panel: a lab screening five targets and a lab screening thirty will disagree by construction. Ours is listed.
  • Extraction efficiency from a peptide matrix varies; the extraction control tells you whether the "not detected" is trustworthy.
  • Culture methods need live organisms and days; PCR needs neither. They answer different questions.

That's why every result here prints the method and the limit next to the number. The full science article on why tests vary.

Methods described are Vialidate's own and are published so results can be compared with other laboratories' on equal terms. Nothing on this page is medical advice. ISO 17025 accreditation in progress.