Specimen collection
A cervical, penile/vaginal or urethral swab specimen (or urine) is collected and placed into CarciScan Viral Transport Medium.
CarciScan · HPV-DNA Screening Assay
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A PCR-based HPV-DNA assay. Detects all 14 high-risk HPV types. 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, penile/vaginal or urethral swab specimens, or urine, collected using CarciScan Viral Transport Medium.
Read the verbatim intended-use statement
“This kit is an in vitro diagnostic (IVD) molecular diagnostic test developed for the qualitative detection of high-risk Human Papillomavirus (HPV) genotypes, including HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, in human clinical specimens. The kit enables specific genotyping of HPV 16, 18, and 45, while screening for the other high-risk HPV genotypes.”IFU, Intended Use, p.1, Rev 04
14High-risk HPV types detected (3 individually genotyped: 16, 18, 45)
96Reactions per kit
60 ngDNA input per reaction
6 monthsSpecimen stability at −20°C
8Compatible five-channel qPCR systems
26 gKit weight, 75 × 55 × 65 mm
The CarciScan kit box.
Clearly documented.
CarciScan HPV PCR Assay, REF CSHPV10. Up to 96 reactions per kit, 75 × 55 × 65 mm, 26 g.
HPV 16·HPV 18·HPV 45
These three types are individually genotyped and reported. The commercial CarciScan kit (REF CSHPV10) additionally screens 11 further high-risk genotypes — HPV31, HPV33, HPV35, HPV39, HPV51, HPV52, HPV56, HPV58, HPV59, HPV66 and HPV68 — together as a single pooled result, for all 14 high-risk HPV types covered by the IFU. (Source: IFU, Intended Use / Table 1, Rev 04)
Each of the three genotyped types is reported individually, not as a single pooled result. Together, HPV16, HPV18 and HPV45 account for approximately 80% of HPV-positive cases and are considered the genotypes most likely to progress to cervical cancer. (Source: CarciScan scientific advisor, technical Q&A)
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 compatible five-channel qPCR equipment, with an RNase P internal control (Internal Positive 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 Review
Follow-up
A cervical, penile/vaginal or urethral swab specimen (or urine) is collected and placed into CarciScan Viral Transport Medium.
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 all 14 high-risk HPV genotypes in a single run, individually genotyping HPV16, HPV18 and HPV45 and screening the remaining 11 types (HPV31, 33, 35, 39, 51, 52, 56, 58, 59, 66, 68) as a pooled result. An internal control (RNase P, human RNase P gene) is run with every sample as the Internal Positive Control, to confirm DNA extraction and PCR performance. The assay is compatible with five-channel real-time PCR equipment, including Roche LightCycler 480 Instrument II, Corbett Rotor-Gene, Applied Biosystems 7500 Fast, Bio-Rad CFX96, Bio-Rad CFX384 Touch, BioMolecular Systems Bio 4-Channel+HRM, Drawell Gentier 96E and Applied Biosystems QuantStudio 5/7/12K with compatible filter sets. CarciScan uses five detection channels: FAM, HEX, ROX, CY5 and CY5.5.
Source: IFU Table 1 (Materials Provided) & Table 5 (Control design), Rev 04. Internal control confirmed as RNase P (Human RNase P Gene, CY5 channel).
Clinical evidence
What’s genuinely documented, with the caveats intact.
We link every claim to its source and state plainly what each study does and doesn’t prove.
Limit of detection validated against Karolinska reference plasmids
What this shows
CarciScan’s limit of detection is established using International HPV Reference Center plasmids from the Karolinska Institute, achieving 95% or greater positivity across 20 replicates. These results were presented at the European Society of Gynaecological Oncology (ESGO).
Important limitation
This is a laboratory limit-of-detection study using reference plasmid material, not a clinical-accuracy or patient-specimen result. It was presented at a scientific conference, not published as a peer-reviewed journal article.
Details and source
Source: company brochure, p.2 (LOD validation, ESGO presentation).
Karolinska Institute / WHO ten-country study
What this shows
CarciScan is one of 13 HPV assays evaluated in a ten-country collaborative study led by Prof. Joakim Dillner at the Karolinska Institute, covering 100 CIN2+ cases and 200 controls.
Important limitation
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.
Details and source
Source: Dillner et al., medRxiv, 4 Feb 2026.
Ghana screening study
What this shows
CarciScan is the assay used in the published, peer-reviewed CarciSCAN study protocol in Ghana (n=1,000, Cancer Control, 2025).
Important limitation
This is a protocol publication. Results are not yet available as of the data-room snapshot; full study results are expected from 2029.
Details and source
Source: DOI 10.1177/10732748251330698.
13-sample analytical study
What this shows
An early analytical study on 13 specimens showed 95% sensitivity per HPV type and 100% specificity.
Important limitation
Small, non-population analytical sample, not a powered clinical CIN2+/CIN3+ study. Not a general clinical accuracy claim.
Details and source
Source: CarciScan_Phase1_Karolinska_WHO_UnderReview.pdf.
Prof. Murat Gültekin, Hacettepe University
What this shows
Letter dated 6 Jul 2026 supporting a Philippines pilot / proof-of-concept deployment, from a co-author on the Karolinska/WHO evaluation.
Important limitation
This is individual expert support for a pilot deployment, not a clinical validation study, regulatory approval, or institutional endorsement by Hacettepe University or any regulatory body.
Details and source
Letter on file, dated 6 Jul 2026; the author is a co-author on the Karolinska Institute / WHO ten-country evaluation above.
Connected to Türkiye’s national HPV screening program
What this shows
CarciScan’s scientific foundation is connected to Prof. Dr. Murat Gültekin, architect of Türkiye’s national HPV DNA screening program, with published real-world data covering more than 5 million women.
Important limitation
This reflects Prof. Gültekin’s national program leadership, not a CarciScan-specific screening volume: we do not present “5 million screened with CarciScan” as a product claim.
Details and source
Context: Türkiye’s national HPV DNA screening program, led by Prof. Dr. Murat Gültekin.
No evidence items in this category yet.
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.
The full commercial CarciScan configuration that Malaya United distributes is three components used together: a sample collection kit, the DNA Elixir™ Isolation Kit (DNA extraction), and the CarciScan HPV PCR Assay (PCR kit). (Source: CarciScan scientific advisor, technical Q&A)
CarciScan HPV PCR Assay (REF CSHPV10, 1 kit = up to 96 reactions):
- 2 × 625 µL Master PCR Mix
- 2 × 40 µL HPV Enzyme Mix
- 2 × 300 µL PCR Grade Water
- 3 × 35 µL Positive Control
Shown alongside, as separate REFs used together: a transport tube with CarciScan Viral Transport Medium (REF VTM1001, 1.2 mL) and a collection swab (single-use, not sterile) — together the sample collection kit.
The DNA Elixir™ Isolation Kit (DNA extraction reagents) is the third component of the commercial configuration; its own REF number is not yet documented in the data room.
Running CarciScan also requires standard lab consumables purchased separately and not included in the kit: pipette tips, mini-centrifuge tubes and ethanol. (Source: CarciScan scientific advisor, technical Q&A)
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 | All 14 high-risk types: HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 (16, 18, 45 individually genotyped; remaining 11 as a pooled result) |
| Intended use | See verbatim statement in the Assay section above |
| Internal control | RNase P (human RNase P gene) — Internal Positive Control, CY5 channel |
| Detection channels | CY5.5 = HPV16 · HEX = HPV18 · ROX = HPV45 · FAM = HPV31/33/35/39/51/52/56/58/59/66/68 (pooled) · CY5 = RNase P (Internal Positive Control) |
| Instrument compatibility | Five-channel real-time PCR equipment, including Roche LightCycler 480 Instrument II, Corbett Rotor-Gene, Applied Biosystems 7500 Fast, Bio-Rad CFX96, Bio-Rad CFX384 Touch, BioMolecular Systems Bio 4-Channel+HRM, Drawell Gentier 96E, Applied Biosystems QuantStudio 5/7/12K with compatible filter sets (FAM, HEX, ROX, CY5 and CY5.5). |
| Time to result | Less than 4 hours |
| Maximum samples per run | Up to 96 patient samples per PCR run (full-plate batch); no fixed 20-sample cap. Recommended batch size for routine high-volume screening is also 96. (Source: CarciScan scientific advisor, technical Q&A) |
Specimen
| Specimen type | Cervical swab, penile/vaginal swab, urethral swab, or urine |
|---|---|
| Specimen volume | 60 ng gDNA per reaction |
| Stability | 2 to 30°C, up to 72 hours; −20°C if extraction is delayed |
| Transport | 2 to 30°C (or −20°C if delayed), upright, cap fully closed |
Kit
| Components | See “What’s in the box” above |
|---|---|
| Full commercial configuration | Sample collection kit + DNA Elixir™ Isolation Kit (DNA extraction) + CarciScan HPV PCR Assay (REF CSHPV10). (Source: CarciScan scientific advisor, technical Q&A) |
| 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 (specific swab material not specified in the IFU) |
| Swab dimensions | pending IFU |
Packaging
| Kit box dimensions | 75 × 55 × 65 mm, 26 g |
|---|---|
| Unit of sale | 1 box = up to 96 reactions |
| Cases per carton | pending IFU |
Storage
| Temperature range | Reagents: −10°C to −30°C (not recommended at +4°C, except reagents in daily use). Avoid more than 3 freeze-thaw cycles; keep cold during use; store the reaction mixture in the dark. |
|---|---|
| Shelf life, CSHPV10 kit | pending IFU (label expiry date only, no fixed month figure documented) |
| Shelf life, VTM | pending IFU (no shelf-life figure for the transport medium found in the IFU) |
Labelling
| REF | CSHPV10 |
|---|---|
| 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 |
| Current IFU revision | Rev 04 (product code CSHPV10) — per the IFU’s own revision history, rev 04 is an editorial/layout-only update; no change to intended use, kit contents, protocol, thermal profile, interpretation criteria or performance data versus earlier revisions. (Source: IFU Revision history, p.9) |
Warnings & precautions
Shown verbatim from the IFU.
The current IFU (CSHPV10, Rev 04) does not contain a separate “Limitations” section. Reproduced below is the complete Warnings and Precautions section, p.1.
“Read these instructions carefully before starting the procedure.”
“For in vitro diagnostic use only.”
“It should be used by laboratory personnel trained in vitro diagnostic procedures.”
“Follow standard precautions. All patient samples and Positive Controls should be considered potentially infectious samples and processed accordingly.”
“This test should be performed in accordance with Good Laboratory Practices.”
“Do not use the kit after the expiration date.”
“Do not eat, drink, smoke, apply cosmetics or touch contact lenses in areas where reagents and human samples are used.”
“Treat all samples as if they are infectious using safe laboratory procedures.”
Beyond the pilot
Scaling from a pilot lab to nationwide screening.
The manufacturer’s scientific advisor on what changes as CarciScan moves from a first lab to several hundred or several thousand samples per day.
Pilot setup, sized to fit
The right workflow, batch size, staffing and equipment for a first laboratory depend on volume, existing infrastructure, budget and timeline. The manufacturer can provide consultancy on setting up the lab, or deliver the on-site infrastructure directly, where needed.
Tracking software becomes the priority
The single most important addition when scaling up is tracking software integrated into logistics: a central system to know who has been sampled, analysed and recontacted if positive, and when to schedule the next test if negative — alongside where each sample physically is, how many kits each service center holds, and how kit consumption relates to coverage. The manufacturer can advise on this, or develop tracking software for a nationwide Philippine screening program.
Measuring whether it works
Going nationwide requires outcome metrics as feedback — evidence that the program is actually finding disease and saving lives, and that it is cost-effective enough to sustain at scale.
Source: CarciScan scientific advisor, technical Q&A.
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 all 14 high-risk types in cervical specimens using multiplex PCR, individually genotyping HPV16, HPV18 and HPV45 and screening the remaining 11 types as a pooled result. (IFU Intended Use, p.1, Rev 04)
Which HPV genotypes does the commercial kit cover?
The commercial kit (REF CSHPV10) covers all 14 high-risk HPV genotypes: HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. HPV16, HPV18 and HPV45 are individually genotyped; the remaining 11 types are detected together as a pooled screening result. (IFU Intended Use / Table 1, p.1–2, Rev 04)
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, penile/vaginal or urethral swab specimens, or urine, collected using CarciScan Viral Transport Medium (or a urine container / Vis-Express, depending on specimen type). Stable at 2–30°C for up to 72 hours, or at −20°C if the extraction procedure is delayed. (IFU Table 2, p.3, Rev 04)
Which instruments and systems are compatible with CarciScan?
CarciScan uses five detection channels: CY5.5 (HPV16), HEX (HPV18), ROX (HPV45), FAM (pooled HPV31/33/35/39/51/52/56/58/59/66/68) and CY5 (RNase P internal control). The assay is compatible with five-channel real-time PCR equipment, including the Roche LightCycler 480 Instrument II, Corbett Rotor-Gene, Applied Biosystems 7500 Fast, Bio-Rad CFX96, Bio-Rad CFX384 Touch, BioMolecular Systems Bio 4-Channel+HRM, Drawell Gentier 96E, and Applied Biosystems QuantStudio 5/7/12K. (IFU, Instrumentation and Software, Rev 04)
Which qPCR instruments are compatible with CarciScan?
Per the IFU, CarciScan is compatible with five-channel qPCR equipment, including the Roche LightCycler 480 Instrument II, Corbett Rotor-Gene, Applied Biosystems 7500 Fast, Bio-Rad CFX96, Bio-Rad CFX384 Touch, BioMolecular Systems Bio 4-Channel+HRM, Drawell Gentier 96E, and Applied Biosystems QuantStudio 5/7/12K, each with compatible filter sets. (IFU, Instrumentation and Software, Rev 04)
What is the maximum number of patient samples per PCR run, and what batch size is recommended?
Centers using automated systems, and experienced manual-PCR labs, can run a full 96-well plate in a single batch; there is no fixed 20-sample-per-run limit. 96 samples is both the current validated maximum and the recommended batch size for routine high-volume screening. Across four such runs, one validated instrument can process up to 96×4 samples in an 8-hour shift. (Source: CarciScan scientific advisor, technical Q&A)
How many patient results can we obtain from one 100-reaction kit?
Every batch requires one positive and one negative control (the positive controls can be mixed into a single tube), consuming reactions from the same 100-reaction kit. Run as one full batch, 100 reactions are enough for up to 96 patient results. Actual yield depends on batch size and how often controls must be repeated: running high-throughput batches with few repeats can reach close to 96 patient results per kit, while testing patients individually, one at a time, consumes proportionally more reactions for repeated controls and yields as few as roughly 33 patient results per kit. (Source: CarciScan scientific advisor, technical Q&A)
Is training and technical support available when setting up a new lab?
On-site training is available, and free online troubleshooting support is offered until the end of the first year. The manufacturer recommends three physically separate rooms (DNA extraction, PCR setup, and post-PCR handling), ideally with slightly positive pressure, since handling post-PCR product in the extraction room risks contamination. Freeze-thaw cycles should be minimized, and PCR plates and caps should be high-quality optical polypropylene to avoid read errors. (Source: CarciScan scientific advisor, technical Q&A)
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.
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