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Pillar guide · Rapid test FAQ
Rapid Test FAQ: Fluorescent Lateral Flow Assays, Cancer Biomarkers and the OncoFirm™ Platform
Straight answers to the questions clinicians, laboratories, partners and patients ask most about lateral flow rapid tests: how they work, what fluorescent reading adds, what cancer biomarkers can and cannot do, how tests are regulated, and where the OncoFirm™ platform stands today. Every answer is written to be accurate, sourced and honest about limits.
At a glance
Covers
25 questions in 5 topics
Technology
Fluorescent lateral flow assays read by a handheld reader
First assays
CEA and PSA, quantitative, in development
Important limit
No protein-marker rapid test is recommended for cancer screening
OncoFirm™ status
Research use only; not cleared, approved or for sale
On this page
Key facts
Rapid tests in three numbers
5–20 mintypical time to result for lateral flow tests, depending on the assay
25.49%more confirmed positives found by a digital reader than by self-reading, in 1.49 million COVID-19 tests
ng/mLwhat a calibrated fluorescent reader reports, instead of a yes-or-no line
Sources: Koczula and Gallotta 2016; UK Health Security Agency 2022. Full citations below.
How it works
Inside a fluorescent lateral flow test
A sandwich immunoassay on a strip: labelled antibodies bind the target, the test line captures it, the control line confirms the run, and a reader turns the fluorescence into a concentration.
Benefits, honestly
What rapid tests do well, and their limits
| Benefit | What is true | The caveat |
|---|---|---|
| Fast results | Results in minutes, during the same visit | Speed only helps if the result is reliable and linked to a clinical pathway |
| Easy to use | Simple steps suit trained non-laboratory staff | Training, quality control and correct sample handling still matter |
| Low cost | Low manufacturing and running costs | Quantitative tests add a reader; total cost includes QC and connectivity |
| Portable | Works in clinics, mobile units and remote sites | Storage temperature and humidity limits must be respected |
| Small samples | Fingerstick blood or other easy samples | Each sample type must be validated; serum results do not transfer automatically |
| Broad use | Infections, pregnancy, cardiac markers and more | In cancer, protein markers are for monitoring and risk assessment, not population screening |
| Decentralized testing | Brings testing to people far from laboratories | Results must reach the record; see LIS connectivity |
| Digital readers | Remove subjective reading and report numbers | Reader performance must be validated for each assay |
For a side-by-side comparison with laboratory testing, see fluorescent LFA vs traditional testing; for the global case for affordable tests, the global need for affordable diagnostics.
FAQ
Rapid test basics
What is a lateral flow rapid test?
A lateral flow assay (LFA) is a paper-based test strip in which a liquid sample flows by capillary action past antibodies that recognise a target molecule. A visible or fluorescent line forms where the target is captured. Pregnancy tests and COVID-19 antigen tests are familiar examples. How lateral flow assays work →
How long do lateral flow tests take?
Most give a result in about 5–20 minutes, depending on the assay. OncoFirm™ assays are being designed to a target of 20 minutes or less; this is a development target, not a validated claim.
What samples can rapid tests use?
Depending on the test: fingerstick or venous blood, serum, plasma, urine, saliva or swabs. Protein cancer markers such as CEA and PSA are measured in blood. The sample type must match what the test was validated for.
Do rapid tests need a laboratory?
Visual tests need no equipment. Quantitative fluorescent tests need a small reader but not a full laboratory analyser. Both still need trained users, quality control and, in the US, the right CLIA categorization for the setting. Fluorescent LFA vs traditional testing →
Are rapid tests as accurate as laboratory tests?
It depends on the test. Some rapid tests perform close to laboratory methods; many are less sensitive, especially at low concentrations. Performance must be shown for each test, intended use and population, and results are interpreted alongside clinical findings.
FAQ
Fluorescent and quantitative testing
What is a fluorescent lateral flow assay?
Instead of coloured gold or latex particles, the antibodies are labelled with fluorescent particles. A reader shines light of one wavelength on the test line and measures the light emitted at another, which is proportional to the amount of target captured. OncoFirm™ fluorescent platform →
Why does a quantitative result matter?
Many biomarkers are interpreted as numbers, not yes-or-no answers. CEA and PSA are followed as trends over time, and decisions depend on the value and its change. A visual line cannot give a reliable number; a calibrated reader can.
Does a digital reader improve accuracy?
Readers remove subjective visual interpretation. In 1.49 million COVID-19 test reports, a digital reader detected 25.49% more PCR-confirmed positives than people reading their own tests. That reader imaged visual strips, so it illustrates the principle rather than proving any specific fluorescent reader's performance. Digital diagnostic readers →
What is the hook effect?
At very high concentrations, excess target can saturate the antibodies and produce a falsely low signal. Well-designed quantitative assays characterise this range and flag or dilute samples above it.
How are results kept consistent between test batches?
Each reagent lot is calibrated, ideally traceable to an international reference standard. OncoFirm™ plans traceability to the WHO international standards for CEA (NIBSC 73/601) and PSA (NIBSC 17/100). One reader, one strip →
FAQ
Cancer biomarkers
Can a rapid test screen for cancer?
Not on its own. No protein-marker rapid test is recommended for screening the general population for cancer. Proven screening uses tests such as mammography, HPV testing, stool tests or colonoscopy, and low-dose CT for high-risk people. Early detection evidence hub →
What is CEA used for?
Carcinoembryonic antigen is mainly used to monitor colorectal cancer after treatment and during therapy. Guidelines state it should not be used as a screening test. CEA guide →
What is PSA used for?
Prostate-specific antigen is the entry point to a shared-decision, risk-stratified prostate pathway that now often includes MRI before biopsy. It is also used to monitor men after prostate cancer treatment. PSA guide →
What about AFP and CA-125?
AFP is used with ultrasound every six months to watch for liver cancer in people with cirrhosis. CA-125 is used to monitor ovarian cancer; screening trials with CA-125 did not reduce deaths. In OncoFirm™ plans, AFP is a future pipeline candidate. Causes of high AFP →
What is the Thomsen-Friedenreich (TF) antigen?
A carbohydrate antigen exposed on many cancer cells and studied as a research biomarker. OncoFirm™ TF assay concepts are at concept stage. TF antigen guide →
FAQ
The OncoFirm™ platform
What is OncoFirm™ developing?
A quantitative fluorescent lateral flow platform: single-use test strips read by a handheld digital reader. The first assays are designed to measure CEA (1–100 ng/mL) and PSA (0.5–50 ng/mL). Platform overview →
Who is the platform intended for?
Clinicians and laboratories in settings where a central laboratory is far away or slow, including community clinics and resource-limited health systems, working within guideline-defined uses such as CEA monitoring and PSA risk assessment. Point-of-care oncology →
Will results connect to hospital systems?
That is a design objective: results with operator, QC, lot and device identifiers, exported through standard interfaces such as POCT01-A2, HL7 v2.5.1 and FHIR, with LOINC coding and offline store-and-forward. LIS connectivity guide →
Can the platform test several markers at once?
Multi-marker panels are being researched under the OncoFirm™ MultiDx concept. Any panel would need its own validation and would make no multi-cancer detection claim without evidence. Multi-biomarker blood tests →
Where can I read the evidence behind OncoFirm™ content?
Each OncoFirm™ guide links its sources. The Cancer Biomarker Atlas and the Early Detection Evidence Hub summarise the evidence on markers and screening. Cancer Biomarker Atlas 2026 →
FAQ
Regulation and availability
Are OncoFirm™ tests FDA cleared or CE marked?
No. OncoFirm™ assays, reader and software are in development, have not been cleared or approved by the FDA or any other regulatory authority, are not CE marked, are for research use only and are not for sale.
How are rapid diagnostic tests regulated in the United States?
In vitro diagnostics are regulated by the FDA, usually through 510(k) clearance, De Novo or premarket approval depending on risk. Separately, CLIA categorizes each test as waived, moderate or high complexity, which decides where it can be used.
What does CLIA-waived mean?
A CLIA-waived test is simple enough, with low enough risk of an incorrect result, to be used in sites holding a certificate of waiver, such as many physician offices. Waiver is granted per test, not per technology.
What evidence would a new cancer marker test need?
First analytical validity (accuracy, precision, measuring range, interference), then clinical validity in the intended population, and ultimately evidence that using it improves outcomes. Regulators and guideline bodies weigh each step. Evidence ladder →
How do I partner with or invest in OncoFirm™?
Clinicians, laboratories, research groups and investors can contact the team through the collaboration and investor inquiry forms, or at [email protected]. Collaboration inquiry →
Guide directory
Go deeper
Technology
Biomarkers
Evidence
Sources
References
- Koczula KM, Gallotta A. Lateral flow assays. Essays Biochem. 2016;60(1):111–120. doi.org/10.1042/EBC20150012
- Land KJ, Boeras DI, Chen XS, Ramsay AR, Peeling RW. REASSURED diagnostics to inform disease control strategies. Nature Microbiology. 2019;4:46–54. doi.org/10.1038/s41564-018-0295-3
- UK Health Security Agency. Evaluation of a digital reader for COVID-19 lateral flow device results. November 2022. assets.publishing.service.gov.uk/media/6363de468fa8f505764b007b/LFD-digital-reader-november-2022.pdf
- U.S. Food and Drug Administration. CLIA categorizations. www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations
- U.S. Food and Drug Administration. Overview of IVD regulation. www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation
- Locker GY, et al. ASCO 2006 update of recommendations for the use of tumor markers in gastrointestinal cancer. J Clin Oncol. 2006;24:5313–5327. ascopubs.org/doi/10.1200/JCO.2006.08.2644
- USPSTF. Prostate cancer: screening. Final recommendation, May 8, 2018. www.uspreventiveservicestaskforce.org/uspstf/recommendation/prostate-cancer-screening
- Singal AG, et al. AASLD practice guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma. Hepatology. 2023;78:1922–1965. journals.lww.com/hep/fulltext/2023/12000/aasld_practice_guidance_on_prevention,_diagnosis,.30.aspx
- Menon U, et al. Ovarian cancer population screening and mortality after long-term follow-up in UKCTOCS. Lancet. 2021;397:2182–2193. www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00731-5/fulltext
- Clinical and Laboratory Standards Institute. POCT01-A2: Point-of-Care Connectivity. clsi.org/shop/standards/poct01/
About this FAQ. Written by the OncoFirm™ Scientific Team from peer-reviewed literature, regulatory sources and clinical guidelines, linked above and in each related guide, reflecting public information as of 1 October 2026. It is for general education, is not medical advice and does not state or imply that any OncoFirm™ product is cleared, approved, CE marked or authorized for clinical use. OncoFirm™ assays, reader and software are in development, are for research use only and are not for sale.
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