Resource center
Point-of-care testing: where rapid tests fit
Point-of-care testing brings the test to the patient instead of sending the specimen to a laboratory. This guide covers where rapid tests fit and the quality practices that keep results reliable.
- Guide
- Reviewed October 2026
What point-of-care testing means
Point-of-care testing is diagnostic testing performed near or at the place where the patient is seen, with the result available in time to inform the same encounter. The EU regulation on in vitro diagnostics uses the term near-patient testing for devices intended to perform testing outside a laboratory environment, generally near to or at the side of the patient, by a health professional.
Testing outside the laboratory is still laboratory medicine. ISO 15189:2022, the international standard for quality and competence in medical laboratories, states that it also applies to point-of-care testing. Lateral flow rapid tests are a common instrument-free format for this work; our guide to lateral flow tests explains how they produce a result.
Where rapid tests fit: clinics, outreach and emergency settings
Clinics and primary care
A clinic without an analyzer can run a qualitative test during the consultation and decide on referral or laboratory follow-up before the patient leaves. Typical examples are STI rapid tests and hepatitis and HIV rapid tests, used within the national testing algorithm.
Outreach and community programs
Mobile teams work without a laboratory, stable power or refrigeration. Single-use cassettes that store within a labeled temperature range are practical here, for example malaria and dengue rapid tests. The constraints are transport temperature, lighting for reading and a reliable way to record results.
Emergency settings
In emergency care, cardiac marker rapid tests can add information while laboratory results are pending. A qualitative rapid test supports, and never replaces, the ECG and laboratory troponin testing required by the local chest-pain protocol.
Quality practices for point-of-care testing
- Training. Each operator is trained on the specific product and its insert, and competence is checked before testing patients and at set intervals.
- External controls. The built-in control line shows that the strip ran; it does not show that the test detects the analyte. Positive and negative external controls are run as the insert and local policy require, commonly with a new lot, a new shipment or a new operator.
- Lot records. Record the lot number and expiry date with every result, along with operator, date and time. Lot records make it possible to trace results if a problem is reported.
- Reading within the stated window. Use a timer. Read the result at the time the insert specifies, and do not interpret lines that appear later.
- Storage. Keep kits within the labeled temperature range, and leave the pouch sealed until the test is run.
Limits of testing outside the laboratory
Most rapid tests are qualitative and are generally less analytically sensitive than laboratory methods. Results are an aid to diagnosis and must be interpreted by a clinician with other clinical and laboratory findings. Reactive results for infections such as HIV or hepatitis need confirmation under the national algorithm.
Point-of-care sites also need procedures for specimen identification, sharps and waste, and for reporting results to the patient record. Digital cassette readers can help with records, with limits of their own.
First Diagnostic™ Corporation brands and distributes lateral flow rapid tests for professional in vitro diagnostic use. See the rapid tests catalog, the background guide to rapid diagnostic tests, or contact us about a program.
Frequently asked questions
Who should oversee a point-of-care testing program?
A named person or group with laboratory quality experience, often the facility laboratory. They select the tests, approve procedures, organize training and review control and lot records.
How often should external controls be run?
Follow the product insert and local policy. Common triggers are a new lot, a new shipment, a new operator, and any suspicion that kits were stored outside the labeled range.
Can rapid tests be used in the field without refrigeration?
Only within the storage and operating temperatures printed on the kit label and in the insert. Check those ranges for each product before planning outreach work.
Keep reading
- What are rapid diagnostic tests (RDTs)? — Formats, analyte types and how to evaluate a test.
- Lateral flow tests explained — The pillar guide to the technology.
- Digital cassette readers for lateral flow tests — Objective reading and record keeping.
- Country Station — Rapid test supply by region.
References
- International Organization for Standardization. ISO 15189:2022, Medical laboratories — Requirements for quality and competence (edition 4, 2022). iso.org
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, Article 2(6) (device for near-patient testing). EUR-Lex. eur-lex.europa.eu
- World Health Organization. In vitro diagnostics (health topic page). Accessed October 2026. who.int
Regulatory status: Products shown on this website are for professional in vitro diagnostic use. They are not cleared, approved or authorized by the U.S. Food and Drug Administration and are not offered for sale in the United States. Product availability and regulatory status vary by country; contact us for the status in your market.