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Rapid test FAQ
Answers to the questions distributors, laboratories and procurement teams ask most often about our rapid tests.
- Products
- Ordering
- Documentation
Products
What does First Diagnostic supply?
Lateral flow rapid tests under the ATFirst™ and inSTIcheck™ brands, covering sexually transmitted infections, hepatitis and HIV, malaria and dengue, influenza, ToRCH serology, cardiac markers and general health tests. See the rapid tests catalog.
Does First Diagnostic manufacture the tests?
No. First Diagnostic brands and distributes tests made by established IVD manufacturers.
Are the tests for professional use?
Yes. The products with pages on this site are for professional in vitro diagnostic use. For items supplied on request, the insert states the intended user.
How are the tests stored?
Follow the kit label. The inserts we publish state storage at 2–30 °C, or 4–30 °C for the syphilis test, in the sealed pouch, without freezing.
How accurate are the tests?
Performance depends on the product. Where a published insert reports sensitivity and specificity against a comparator method and the figures agree with its data table, the product page reproduces them with the sample counts; for other products, see the insert. No rapid test is right every time, and results are interpreted with other clinical findings.
What is the difference between a rapid test and a lateral flow test?
Rapid test describes the speed; lateral flow describes the technology. Most rapid tests are lateral flow tests. Our lateral flow tests guide explains the format.
Ordering and distribution
How do I request a quotation?
Email sales@firstdiagnostic.com with the products, quantities and destination country, or use the contact page.
How do I become a distributor?
Complete the distributor application. It asks about your licences, storage, quality system and market coverage. Submitting it does not guarantee appointment or exclusivity.
Which countries do you supply?
Customers outside the United States. Availability depends on the product and on local registration; the Country Station explains how supply to a new country starts.
What pack sizes are available?
Most cassette tests are packed in kits of 20. The pack size for each product is confirmed on your quotation.
Can I buy online?
No. Orders are placed by quotation with the sales desk.
Documentation and regulatory
Where can I download product inserts?
Ten documents are on the product inserts page. Others are sent on request.
Which products are CE marked?
The inserts for ATFirst™ HBsAg, inSTIcheck™ Chlamydia, inSTIcheck™ Gonorrhea, ATFirst™ Malaria P.f. and ATFirst™ Rubella IgG/IgM carry the CE mark. For other products, documentation is available on request. See quality and regulatory information.
Are the products cleared by the U.S. FDA?
No. Products shown on this website are not cleared, approved or authorized by the U.S. Food and Drug Administration and are not offered for sale in the United States.
How do I report a problem with a product?
Email sales@firstdiagnostic.com with the product name, catalog number, lot number, expiry date and a description. Keep the affected kits.
Still have a question?
The sales desk answers product, documentation and distribution questions by email.
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.