Specimen collection
A clinician-collected cervical specimen is collected and placed into CarciScan Viral Transport Medium. (Self-collection is a future roadmap goal, to be validated through research.)
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 clinician-collected cervical specimens collected using CarciScan Viral Transport Medium. Self-collected specimens, such as urine and vaginal swabs, are a future roadmap goal, to be validated through research.
Read the verbatim intended-use statement
“CarciScan HPV PCR Assay is an in vitro diagnostic real-time PCR test for the qualitative detection of DNA of 14 high-risk human papillomavirus (HR-HPV) genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) in clinician-collected cervical specimens transported in CarciScan Viral Transport Medium. The assay specifically identifies HPV16, HPV18 and HPV45 and reports the remaining 11 genotypes in three pools. The test is intended for use as an aid in cervical cancer screening in conjunction with clinical findings and other laboratory results; it is not intended as a stand-alone diagnostic or for monitoring treatment. For professional laboratory use only.”IFU, Intended Use, p.1, Rev 06
14High-risk HPV types detected (3 individually genotyped: 16, 18, 45)
100Reactions per kit
60 ngDNA input per reaction
6 monthsSpecimen stability at −20°C
283Specimens in the validated clinical performance study
26 gKit weight, 75 × 55 × 65 mm
The CarciScan kit box.
Clearly documented.
CarciScan HPV PCR Assay, REF CSHPV10. 100 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 — across three pooled results (Pool 1: 33/56/68/66, Pool 2: 39/35/58/52, Pool 3: 59/51/31), for all 14 high-risk HPV types covered by the IFU. (Source: IFU, Intended Use / Table 1, Rev 06)
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)
Inside the kit
We take the CarciScan kit apart.
Scroll down and we open the box: what is inside, how a laboratory runs it, and what the result tells the clinician.
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01 · The kit
One box, made for the laboratory.
CarciScan HPV PCR Assay is an in vitro diagnostic real-time PCR test. It detects the DNA of 14 high-risk HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
For professional laboratory use.
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02 · Inside
Six tubes in a card insert.
We open the lid. Two amber tubes and four clear tubes sit in a white card insert, enough for 100 reactions per reaction mix.
Every specimen and every control takes one well in each of the two mixes.
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03 · Components
Five components, two reaction mixes.
- Reaction Mix 1
- HPV45, HPV18, HPV16 and the RNase P internal control, read on FAM, HEX, ROX and Cy5. 1000 µL.
- Reaction Mix 2
- Pool 1, Pool 2 and Pool 3 of the other eleven high-risk types, plus RNase P, on the same four channels. 1000 µL.
- Enzyme Mix (2x)
- Hot-start Taq DNA polymerase, dNTPs and reaction buffer. 2 × 500 µL.
- Positive Control
- Non-infectious synthetic DNA containing all target sequences. 200 µL.
- No Template Control
- Nuclease-free water. 200 µL.
RNase P runs in each mix to monitor specimen adequacy, extraction and amplification.
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04 · The run
From specimen to four channels.
- CollectA clinician collects a cervical brush or swab specimen into CarciScan Viral Transport Medium, which is not part of the PCR kit.
- ExtractThe laboratory extracts nucleic acid, with DNA Elixir Pap as the recommended kit (not provided).
- Set upEach extract goes into both reaction mixes, with a positive control and a no template control in every run.
- AmplifyReal-time PCR reads FAM, HEX, ROX and Cy5. Validated instrument: Bio-Rad CFX384 Touch. Other instruments: bridging pending.
To be used by trained laboratory personnel.
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05 · The result
Three types by name, eleven in three pools.
HPV16, HPV18 and HPV45 are reported individually. The other eleven high-risk types are reported as Pool 1, Pool 2 or Pool 3; the assay does not tell types within a pool apart. Otherwise the report reads HR-HPV not detected, or invalid, and the laboratory re-tests.
The result is an aid in cervical cancer screening, together with clinical findings and other laboratory results. It is not a stand-alone diagnosis, and a negative result does not exclude HPV infection or cervical disease.
Fourteen high-risk types. Two reaction mixes. One result for the clinician’s next step.
Source: CarciScan HPV PCR Assay instructions for use, CSHPV10 Rev06. The kit illustration is rebuilt from photographs of the real carton; tube contents follow the IFU.
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 across two reaction mixes on the validated four-channel qPCR instrument, 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 clinician-collected cervical specimen is collected and placed into CarciScan Viral Transport Medium. (Self-collection is a future roadmap goal, to be validated through research.)
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) across two reaction mixes to detect all 14 high-risk HPV genotypes, individually genotyping HPV16, HPV18 and HPV45 and screening the remaining 11 types (HPV31, 33, 35, 39, 51, 52, 56, 58, 59, 66, 68) across three pooled results. An internal control (RNase P, human RNase P gene) is run in each reaction mix as the Internal Positive Control, to confirm DNA extraction and PCR performance. The assay is currently validated on the Bio-Rad CFX384 Touch Real-Time PCR Detection System (CFX Maestro software). The Roche LightCycler 480 Instrument II, Corbett Rotor-Gene, Applied Biosystems 7500 Fast, Bio-Rad CFX96, BioMolecular Systems Bio 4-Channel+HRM, Drawell Gentier 96E and Applied Biosystems QuantStudio 5/7/12K are listed as compatible platforms with validation bridging pending. CarciScan uses four detection channels: FAM, HEX, ROX and Cy5.
Source: IFU Kit Contents (Table 1) & Interpretation of Results (Table 4), Rev 06. Internal control confirmed as RNase P (Human RNase P Gene, Cy5 channel, in both reaction mixes).
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.
Clinical performance study vs. a CE-IVDR reference HR-HPV test
What this shows
A retrospective, non-interventional study (protocol VSNP004-A/G-HPV-IVD-PER-001, Kocaeli University Clinical Research Ethics Committee KAEK/15.bI.01) tested 283 coded residual cervical specimens against the HPV PLUS ELITe MGB® Kit (ELITe BeGenius®, CE-IVDR) on the Bio-Rad CFX384 Touch. Panel A (screening): PPA 100.00% (177/177), NPA 100.00% (106/106), OPA 100.00% (283/283), Kappa 1.000. Panel G (genotyping): PPA 100.00% (166/166), NPA 100.00% (117/117), OPA 100.00% (283/283), Kappa 1.000. Invalid rate was 0/283; no discordant results were reported.
Important limitation
The sample set is enriched (62.9% HR-HPV positive) and is not representative of a screening population — per the manufacturer, these figures should not be presented as screening-population performance. Individual genotype-level accuracy is not assessable in this report; only panel-level (screening/genotyping) agreement is supported, as per-genotype reference-truth traceability has not yet been documented and the comparator reports most genotypes only as a pool. Single-centre study; performance is established only for the Bio-Rad CFX384 Touch and the extraction procedure used in the study.
Details and source
Source: Clinical Performance Data Summary, CSHPV10.CPDS-008 (11 Sep 2026), citing Clinical Performance Study Report VSNP004-A/G-CPR-001 Rev.02 (21 Sep 2026). Data generated under the OEM configuration REF VSNP004-A; CarciScan CSHPV10 is the same device under a different trade name/REF.
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. QCAS-VBA-24-051581146, covering the manufacturer’s Ümraniye/Istanbul site | Confirmed current in the manufacturer’s IVDR QMS and Transition Declaration (CSHPV10.QTD.002, 11 Sep 2026) | Current, per manufacturer declaration |
| 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 |
| EU IVDR transition | Class C device, Regulation (EU) 2017/746, Annex VIII Rule 3(d); transitional provisions of Article 110(3) IVDR as amended by Regulation (EU) 2024/1860 | Legacy CE (98/79/EC) valid under transition until 31 Dec 2028. IVDR conformity-assessment application lodged with Notified Body GMED (NB 0459), 20 May 2026; technical documentation submission due 30 Apr 2027 | In transition, on track |
| Philippine FDA License to Operate | Medical Device Distributor-Importer/Wholesaler, held by Malaya United Trading Inc. — License No. CDRRHR-NCR-MDI/W-2584369 | Issued 20 Sep 2026, valid to 20 Sep 2027 | Valid, held by the Philippine distributor |
The ÜTS registration states its own future intent to move to IVDR Class C. The Philippine FDA License to Operate (LTO) authorizes Malaya United Trading Inc. to import and distribute this device class; it is a distributor/establishment license, not a product registration or FDA approval of CarciScan itself — the Philippines does not require FDA product registration for this IVD device class. Source for ISO 13485 and IVDR transition rows: manufacturer’s IVDR QMS and Transition Declaration, CSHPV10.QTD.002, 11 Sep 2026 (supersedes the previously-cited certificate No. 2023/MDQMS/11045, which showed a lapsed 09 May 2024 validity date).
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 = sufficient for 100 reactions per reaction mix):
- 1000 µL Reaction Mix 1 (HPV45/HPV18/HPV16/RNase P)
- 1000 µL Reaction Mix 2 (Pool 1/Pool 2/Pool 3/RNase P)
- 2 × 500 µL Enzyme Mix (hot-start Taq polymerase, dNTPs, buffer)
- 200 µL Positive Control (non-infectious synthetic DNA)
- 200 µL No Template Control (nuclease-free water)
Shown alongside, as separate REFs used together: a transport tube with CarciScan Viral Transport Medium (REF VTM1002, 1.8 mL, 100 test) 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; kit contents per IFU Table 1, Rev 06)
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 across three pools: 33/56/68/66, 39/35/58/52, 59/51/31) |
| Intended use | See verbatim statement in the Assay section above |
| Internal control | RNase P (human RNase P gene) — Internal Positive Control, Cy5 channel, included in both reaction mixes |
| Reaction mixes | Reaction Mix 1: FAM = HPV45 · HEX = HPV18 · ROX = HPV16 · Cy5 = RNase P (IPC). Reaction Mix 2: FAM = Pool 1 (33/56/68/66) · HEX = Pool 2 (39/35/58/52) · ROX = Pool 3 (59/51/31) · Cy5 = RNase P (IPC) |
| Detection channels | Four channels: FAM, HEX, ROX, Cy5 |
| Instrument compatibility | Currently validated: Bio-Rad CFX384 Touch Real-Time PCR Detection System (CFX Maestro software), via clinical performance study VSNP004-A/G-HPV-IVD-PER-001 (283 specimens). Also listed, validation bridging pending: Roche LightCycler 480 Instrument II, Corbett Rotor-Gene, Applied Biosystems 7500 Fast, Bio-Rad CFX96, BioMolecular Systems Bio 4-Channel+HRM, Drawell Gentier 96E, Applied Biosystems QuantStudio 5/7/12K. |
| 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 | Clinician-collected cervical specimen (cervical brush/swab), currently validated per IFU Rev 06. Self-collected vaginal, penile, urethral, anal or oral specimens and urine are not yet validated for this device; self-collection and urine-based screening are a future roadmap goal, to be validated through research. |
|---|---|
| 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 = 100 reactions |
| Cases per carton | pending IFU |
Storage
| Temperature range | Reagents: −10°C to −30°C, dark (do not store the unopened kit at +4°C). Components for daily use may be kept at 2–8°C for up to 1 month. Avoid more than 3 freeze-thaw cycles; keep cold during use; protect reaction mixes from light. (IFU, Storage and Handling, Rev 06) |
|---|---|
| Shelf life, CSHPV10 kit | Full performance for 12 months from date of manufacture, stored as specified above; performance declines after 12 months. (Source: Shelf-Life and Storage Matrix, CSHPV.002.SLSM-005) |
| Shelf life, VTM | 24 months, stored at 2–30°C (Source: Shelf-Life and Storage Matrix, CSHPV.002.SLSM-005) |
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 06 (product code CSHPV10) — Rev 06 is an editorial/document-control revision of Rev 05, no further change to intended use, assay configuration, kit contents, protocol, thermal profile, interpretation criteria or performance data. Rev 05 (the prior substantive revision, issued by the legal manufacturer) reconfigured the assay from a single reaction mix with five detection channels to two reaction mixes with four channels, restricted the intended use to clinician-collected cervical specimens only, and restricted the validated instrument list to the Bio-Rad CFX384 Touch. (Source: IFU Revision history, p.8) |
Warnings & precautions
Shown verbatim from the IFU.
Reproduced below are the complete Warnings and Precautions, and Limitations, sections from the current IFU (CSHPV10, Rev 06).
“For in vitro diagnostic use only; to be used by trained laboratory personnel.”
“Treat all specimens and the Positive Control as potentially infectious; follow universal precautions and local biosafety regulations.”
“Use separate areas and dedicated equipment for reagent preparation, specimen addition and amplification to avoid carry-over contamination; use aerosol-barrier tips and change gloves frequently.”
“Do not use reagents after the expiry date or if packaging is damaged. Do not mix components from different lots.”
“Do not eat, drink, smoke or apply cosmetics in the laboratory area.”
“Dispose of specimens and reaction products as biohazardous waste according to local regulations.”
“Report serious incidents related to this device to Vision Biotechnology and to the competent authority of the country of use.”
Limitations
Also shown verbatim from the IFU.
“Results must be interpreted together with cytology, clinical findings and screening guidelines; a negative result does not exclude HPV infection or cervical disease.”
“The assay does not distinguish individual genotypes within Pools 1–3.”
“Performance has been established only for clinician-collected cervical specimens in CarciScan/Vision VTM and the validated instruments listed in section Instruments and Software.”
“Inadequate sampling, improper transport, PCR inhibitors or sequence variation in primer/probe binding regions may cause false-negative results.”
“Cross-contamination during specimen handling may cause false-positive results.”
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 clinician-collected cervical specimens using multiplex PCR, individually genotyping HPV16, HPV18 and HPV45 and screening the remaining 11 types across three pooled results. (IFU Intended Use, p.1, Rev 06)
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 across three pooled results (Pool 1: 33/56/68/66, Pool 2: 39/35/58/52, Pool 3: 59/51/31). (IFU Intended Use / Kit Contents, p.1, Rev 06)
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?
A clinician-collected cervical specimen (cervical brush/swab), placed into CarciScan Viral Transport Medium (1.8 mL). Self-collected specimens, and other specimen types such as urine or penile/urethral/anal/oral swabs, are not yet validated for this device; self-collection and urine-based screening are a future roadmap goal, to be validated through research. Stable at 2–30°C for up to 72 hours, or at −20°C if the extraction procedure is delayed. (IFU, Specimen Collection, Transport and Storage, Rev 06)
Which instruments and systems are compatible with CarciScan?
CarciScan uses four detection channels across two reaction mixes: Reaction Mix 1 reports FAM (HPV45), HEX (HPV18), ROX (HPV16) and Cy5 (RNase P internal control); Reaction Mix 2 reports FAM (Pool 1: 33/56/68/66), HEX (Pool 2: 39/35/58/52), ROX (Pool 3: 59/51/31) and Cy5 (RNase P internal control). The only currently validated instrument is the Bio-Rad CFX384 Touch Real-Time PCR Detection System (CFX Maestro software); Roche LightCycler 480 Instrument II, Corbett Rotor-Gene, Applied Biosystems 7500 Fast, Bio-Rad CFX96, BioMolecular Systems Bio 4-Channel+HRM, Drawell Gentier 96E, and Applied Biosystems QuantStudio 5/7/12K are also listed as compatible platforms, with validation bridging pending. (IFU, Instruments and Software, Rev 06)
Can other qPCR instruments be used, or only the Bio-Rad CFX384 Touch?
Only the Bio-Rad CFX384 Touch is currently validated, via a 283-specimen clinical performance study (13 runs). Other five- and four-channel instruments (e.g. Roche LightCycler 480 II, Corbett Rotor-Gene, Applied Biosystems 7500 Fast/QuantStudio, Bio-Rad CFX96, BioMolecular Systems Bio 4-Channel+HRM, Drawell Gentier 96E) are not yet validated for CarciScan and will only be added to the IFU after the manufacturer completes bridging verification. Instruments used in the Philippines must either be on the validated list or pass documented on-site verification against the manufacturer's control-acceptance criteria on a minimum of 20 samples.
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). The device is in transition to the EU IVD Regulation (IVDR) as a Class C device, covered by the transitional provisions of Article 110(3) IVDR (as amended by Regulation (EU) 2024/1860) until 31 December 2028; a conformity-assessment application has been lodged with Notified Body GMED (NB 0459), with technical documentation submission due 30 Apr 2027. (IFU Symbols p.7; EU Declaration of Conformity, signed 25 Apr 2022; IVDR QMS and Transition Declaration, CSHPV10.QTD.002, 11 Sep 2026)
What is the current ISO 13485 certification status?
Current, per the manufacturer’s IVDR QMS and Transition Declaration (CSHPV10.QTD.002, 11 Sep 2026): ISO 13485:2016 certificate No. QCAS-VBA-24-051581146, covering the manufacturer’s Ümraniye/Istanbul site. This supersedes the previously-cited certificate No. 2023/MDQMS/11045, which showed a lapsed 09 May 2024 validity date.
Who performs specimen collection, trained clinical staff or the patient herself?
Trained clinical staff only, today. CarciScan is validated exclusively for clinician-collected cervical specimens; self-collected specimens (including vaginal self-sampling and urine) have not been validated, and no self-sampling claim is made in the intended purpose, labelling or promotional material for this device. Self-sampling is a future roadmap goal, to be validated through research: the manufacturer has stated a dedicated clinical performance study would be run and the technical documentation, risk file and IFU updated accordingly before any such claim is made. (Source: Self-Collection/Self-Sampling Statement, CSHPV.SCS.006, 11 Sep 2026; IFU Rev 06)
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