Specimen collection
A cervical specimen is collected using an endocervical brush, rayon swab or flocked swab and placed into DNA Elixir™ Preservation Medium.
CarciScan · HPV-DNA Screening Assay
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A PCR-based HPV-DNA assay. Targeted for HPV 16, 18 and 45. One building block in cervical cancer screening.
CarciScan is an in vitro screening test based on multiplex real-time PCR. It detects high-risk HPV DNA in cervical specimens collected using DNA Elixir™ Preservation Medium.
Read the verbatim intended-use statement
“The CarciScan HPV PCR Assay is an in vitro test kit based on multiplex PCR for detection of Human papillomavirus (HPV) DNA in cervical samples collected using DNA Elixir™ Preservation Medium… The kit relies on the amplification of target HPV DNA by PCR and the collection of fluorescence emission by dual-labelled hydrolysis probes to detect 3 high-risk (HR) HPV types in a single run.”IFU, Intended Use, p.2
3High-risk HPV types detected (16, 18, 45)
100Reactions per kit
60 ngDNA input per reaction
6 monthsSpecimen stability at −20°C
Agilent AriaDxValidated instrument
26 gKit weight, 75 × 55 × 65 mm
One kit. Three components.
Clearly documented.
- Kit box CarciScan HPV PCR Assay, REF CSHPV05. 100 reactions per kit, 75 × 55 × 65 mm, 26 g.
- Transport tube (VTM) DNA Elixir™ Preservation Medium, 1.2 mL fill volume. Stable at −20°C up to 6 months, +4°C up to 3 months, ≤25°C up to 1 month.
- Collection swab Single-use, not sterile. Intended for one-time use only.
HPV 16·HPV 18·HPV 45
The commercial CarciScan kit (REF CSHPV05) detects these three high-risk genotypes. A broader panel of up to 15 high-risk HPV types is in research and development and is not currently commercially available.
Pending IFU confirmation
How the CarciScan pathway works
The exact, word-for-word collection procedure from the IFU has not yet been extracted into the approved content for this page. The three stages below restate only facts already documented elsewhere on this page; they are not IFU-verbatim user instructions.
Laboratory processing
The preserved specimen is analyzed by multiplex real-time PCR on the Agilent AriaDx instrument, with an HBB internal control run alongside every sample.
Clinical review
The HPV-DNA result is reviewed together with cytology history, other risk factors and professional guidelines by the treating physician.
The pathway
From specimen to a clear next step.
A collected specimen becomes a laboratory result, then a clinical decision, the same five stages every time.
Specimen
Laboratory
HPV-DNA result
Clinical decision
Follow-up
The CarciScan result is reviewed together with cytology history, other risk factors and professional guidelines by the treating physician. CarciScan does not replace this clinical assessment.
Assay technology
Multiplex real-time PCR with an internal control.
CarciScan uses multiplex PCR with dual-labelled hydrolysis probes (TaqMan principle) to detect HPV16, HPV18 and HPV45 DNA simultaneously in a single run. An internal control (HBB, human beta-globin gene, approximately 190 nucleotides) is run with every sample to confirm DNA extraction and PCR performance. The assay is validated for the Agilent AriaDx instrument with Aria Software v2.1.
Source: IFU “Principles of the Procedure” p.3, “Target Selection” p.3, “Instrumentation and Software” p.5.
Clinical evidence
Documented, with the caveats intact.
Every claim links to its source and states plainly what each study does and does not prove.
Karolinska / WHO reference-center study
CarciScan was one of 13 assays evaluated in an international Karolinska Institutet / WHO reference-center study across 10 countries (100 CIN2+ cases, 200 controls).
The published figures (90.08% pooled sensitivity, 92.00% pooled specificity) are averaged across all 13 assays, not CarciScan-specific. The study is a preprint and has not yet completed peer review. Source: Dillner et al., medRxiv, 4 Feb 2026.
Ghana screening study
CarciScan is the assay used in the published, peer-reviewed CarciSCAN study protocol in Ghana (n=1,000, Cancer Control, 2025).
This is a protocol publication. Results are not yet available as of the data-room snapshot; full study results are expected from 2029. Source: DOI 10.1177/10732748251330698.
13-sample analytical study
An early analytical study on 13 specimens showed 95% sensitivity per HPV type and 100% specificity.
Small, non-population analytical sample, not a powered clinical CIN2+/CIN3+ study. Not a general clinical accuracy claim. Source: CarciScan_Phase1_Karolinska_WHO_UnderReview.pdf.
Regulatory status
Stated exactly as it stands today.
| Item | Framework | Validity | Status |
|---|---|---|---|
| CE marking | Legacy IVDD 98/79/EC (2022), General/Other IVD, not Annex II listed | Declaration of conformity signed 25 Apr 2022 | Valid under legacy IVDD only |
| ISO 13485:2016 | Quality management certificate No. 2023/MDQMS/11045 (IQR) | Validity date on certificate: 09 May 2024 | Renewal status to confirm |
| Turkish ÜTS registration | IVD-Other, registered under IVDD rules | Status “Registered” (Kayıtlı), ÜTS start 20 Feb 2025 | States a future intent to pursue IVDR Class C |
The certificate on file shows a validity date in the past; current renewal status must be confirmed before publication. The ÜTS registration states its own future intent to move to IVDR Class C.
What’s in the box
The contents, as shipped.
CarciScan HPV PCR Assay (REF CSHPV05, 1 kit = 100 reactions):
- 2 × 625 µL Master PCR Mix
- 2 × 40 µL HPV Enzyme Mix
- 2 × 300 µL PCR Grade Water
- 3 × 35 µL Positive Control (HPV16/18/45)
Shown alongside, as separate REFs used together: a transport tube with DNA Elixir™ Preservation Medium (REF VTM1001, 1.2 mL) and a collection swab (single-use, not sterile).
Technical specifications
Every documented field, grouped.
Fields not yet documented in the data room stay visible and are labeled pending IFU.
Assay
| Method | Multiplex real-time PCR, dual-labelled hydrolysis probes |
|---|---|
| Target genotypes | HPV16, HPV18, HPV45 |
| Intended use | See verbatim statement in the Assay section above |
| Internal control | HBB (human beta-globin gene) |
| Instrument compatibility | Agilent AriaDx, Aria Software v2.1 |
| Time to result | pending IFU |
Specimen
| Specimen type | Cervical specimen: endocervical brush, rayon swab or flocked swab |
|---|---|
| Specimen volume | 60 ng gDNA per reaction |
| Stability | −20°C up to 6 months, +4°C up to 3 months, ≤25°C up to 1 month |
| Transport | −20°C to 25°C, upright, cap fully closed |
Kit
| Components | See “What’s in the box” above |
|---|---|
| Single-use | Collection swab: single-use item |
| Sterility | Differs by component: swab not sterile, PCR reagent tubes sterile and DNase/RNase-free, VTM not sterile |
| Swab material | pending IFU |
| Swab dimensions | pending IFU |
Packaging
| Kit box dimensions | 75 × 55 × 65 mm, 26 g |
|---|---|
| Unit of sale | 1 kit = 100 reactions |
| Cases per carton | pending IFU |
Storage
| Temperature range | Unopened: −20°C. After thawing: +4°C, use within 1 week |
|---|---|
| Shelf life, CSHPV05 kit | pending IFU (label expiry date only, no fixed month figure documented) |
| Shelf life, VTM | 24 months from manufacture, stored at 15–25°C |
Labelling
| REF | CSHPV05 |
|---|---|
| LOT format | pending IFU |
| Expiry-date format | pending IFU |
| UDI | pending IFU |
| Insert languages | pending IFU |
| ISO 15223-1 symbols used | Manufacturer, temperature limit, REF, LOT, expiry date (hourglass), CE mark, IVD, “consult instructions for use”, Σ (sufficient for n tests), “keep away from light” |
Regulatory
| CE marking | Legacy IVDD 98/79/EC (2022) |
|---|---|
| Registrations | See Regulatory status above |
Warnings & limitations
Shown verbatim from the IFU.
“The CarciScan HPV PCR Assay detects the DNA of high-risk types HPV16, HPV18, and HPV45. This does not detect DNA of low-risk types HPV6, HPV11 etc. since there is no cancer screening utility for testing low-risk HPV types.”
“The CarciScan HPV PCR Assay for detection of HPV16, HPV18, and HPV45 is not recommended for evaluation of sexual abuse.”
“The performance of the CarciScan HPV PCR Assay has not been adequately established for HPV vaccinated individuals.”
“Infection with HPV does not indicate cytological abnormalities or underlying high-grade CIN, nor does it imply that pre-cancer lesions or cervical cancer will develop. Most HPV infections clear and most women infected with one or more HPV type does not develop pre-cancer lesions or cervical cancer.”
“A negative high-risk HPV, HPV16, HPV18 or HPV45 result does not exclude the possibility of future cytological abnormalities or developing pre-cancer lesions/cervical cancer.”
“Test only the indicated specimen type. The CarciScan HPV PCR Assay has only been validated for use with DNA Elixir™ Preservation Medium.”
“Use of this product must be limited to personnel trained in the techniques of PCR.”
“Only DNA Elixir™ Isolation Kit and Agilent AriaDx are validated with this product. No other sample preparation method or PCR system can be used with this product.”
“A negative results does not preclude the presence of HPV infection, because the results depend on adequate specimen collection, absence of interfering substances and sufficient DNA to be detected.”
“HPV negative results are not intended to prevent women from proceeding to colposcopy.”
“Cervical specimens often show visibly detectable levels of whole blood as pink or light brown coloration. These specimens are processed normally… CarciScan HPV PCR Assay is tested up to concentrations of 2% of whole blood.”
FAQ
Questions a clinical or procurement lead asks first.
Answers drawn directly from the evidence and certification detail above, with the same caveats intact.
What does the CarciScan HPV PCR Assay measure?
CarciScan is an in vitro screening test that detects HPV DNA of the high-risk types HPV16, HPV18 and HPV45 in cervical specimens using multiplex PCR. (IFU p.2)
Which HPV genotypes does the commercial kit cover?
The commercial kit (REF CSHPV05) covers HPV16, HPV18 and HPV45. A broader 15-type panel is in research and development and is not commercially available. (IFU p.2; Technical File §1.1)
Is a CarciScan result a stand-alone clinical determination?
No. CarciScan is a screening test used alongside cytology, and its result is reviewed together with the treating physician’s assessment as part of patient care. It does not replace a physician’s evaluation. (IFU Intended Use, p.2)
What specimen types are accepted and how must they be stored?
Cervical specimens collected with an endocervical brush, rayon swab or flocked swab in DNA Elixir™ Preservation Medium. Stable at −20°C for up to 6 months, at +4°C for up to 3 months, and at ≤25°C for up to 1 month. (IFU p.6/p.7)
Which instruments and systems are compatible with CarciScan?
Only the Agilent AriaDx instrument with Aria Software v2.1, together with the DNA Elixir™ Isolation Kit, are validated for this product. No other system is validated with this product. (IFU p.5, p.15)
Is CarciScan CE marked?
Yes, under the EU’s legacy IVD Directive 98/79/EC from 2022 (legacy conformity procedure), not the newer EU IVD Regulation framework. (IFU Symbols p.20; EU Declaration of Conformity, signed 25 Apr 2022)
What is the current ISO 13485 certification status?
The ISO 13485:2016 certificate on file (No. 2023/MDQMS/11045) shows a validity date of 09 May 2024. [OPEN — needs input: current renewal status must be confirmed with the manufacturer before this answer is published.]
Who performs specimen collection, trained clinical staff or the patient herself?
[OPEN — needs input.] The source documents on file (Technical File §3.4.1, third-party collection-swab package insert) describe collection performed by trained clinical staff. The planned positioning as a “self-sample kit” is a business decision that should be confirmed with the manufacturer before publication.
Talk to the right team.
Clinical documentation, investor materials, or a distribution enquiry, routed directly.