Fortress Fast COVID-19 Home Test - Technical Specification - IgG/IgM Rapid Test

Oct 4, 2026

Fortress Fast COVID-19 Home Test is a solid phase immunochromatographic lateral flow assay for rapid, qualitative and differential detection of SARS-CoV-2 IgG and IgM antibodies from fresh human capillary whole blood collected by finger stick. The kit is a self-contained system with buffer, lancets, test cassette and collection accessories. Results are read after ten minutes, with IgG/IgM specificity of 98.8% and 96.0% and sensitivity of 98.4% and 95.2%. The limit of detection for whole blood corresponds to a dilution of 1:32.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages2

Reading Time5 min

AccessFree to download

Intended Use

Intended End User

Technology

Clinical Performance

Limit of Detection

Conditions That Might Affect the Results

Technical specification – Fortress Fast test Fortress Fast COVID-19 Home Test is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood. The kit contains all the materials required for the procedure in a self-contained kit that includes buffer and all accessories needed to perform the assay and blood collection. Standard kit contents Kit comprises: 1x COVID-19 lateral flow test device 1x Owen Mumford Unistick Touch-contact activated lancet-21G 1x Owen Mumford Unistick Touch-contact activated lancet-23G 1x 5ml buffer bottle, teat and lid, containing 1ml buffer 1x sterile cotton ball 1x alcohol-free wipe 1x small plaster The standard kit used in the self-test study was accompanied by an instructions for use leaflet (IFU) developed for the REACT 2 programme and tailored for use in UK Biobank. Intended Use: The Fortress Fast Test is intended to be used to aid the identification of SARSCoV-2 IgG and IgM antibodies using samples of fresh, human capillary whole blood obtained through a finger stick blood collection technique. Intended End User: The Fortress Fast Test is intended to be used by professionals and laypeople with no knowledge of self-testing. Technology: The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow solid phase immunochromatographic assay for the rapid qualitative and differential detection of IgG and IgM antibodies to SARS-CoV-2 in human capillary whole blood, serum or plasma. The test uses anti-human IgM antibody (test line IgM), anti-human IgG antibody (test line IgG) and rabbit IgG antibody (control line C) immobilised on a nitrocellulose strip. The burgundy-coloured conjugate pad contains recombinant COVID-19 antigens conjugated with colloid gold (COVID-19 conjugates) . When a specimen followed by assay buffer is added to the sample well, if IgM and/or IgG antibodies are present it will bind to COVID-19 conjugates and make an antigen antibodies complex. This complex migrates through the nitrocellulose membrane by capillary action. When the complex meets the line of the corresponding immobilised antibody (anti-human IgM and/or anti-human IgG), the complex is trapped and forms a burgundy-coloured band which confirms a reactive test result. The test results can be read in ten minutes. Clinical performance | Clinical performance characteristic | Fortress Fast COVID-19 Home Test | | | --- | --- | --- | | | IgG | IgM | | Specificity | 98.8% | 96.0% | | Sensitivity | 98.4% | 95.2% | Limit of detection The limit of detection of the Fortress Fast COVID-19 Home Test (Whole Blood) is a dilution rate of 1:32 . Conditions that might affect the results 􀁸 Re-use of a device. The Fortress Fast COVID-19 Home Test is a single-use test which cannot be re-used. 􀁸 Use of the device after the expiry date. 􀁸 Use of a device that has been stored at temperatures less than 2°C or greater than 30°C. 􀁸 Use of a device that has been exposed to the atmosphere for longer than one hour. 􀁸 Excess pressure can cause haemolysis of the red blood cells which may interfere with the results. Squeezing the finger too tightly when collecting the capillary sample should be avoided. 􀁸 The Fortress Fast COVID-19 Home Test has been validated for use with blood samples obtained from a finger-stick puncture. No other sample types should be used. 􀁸 Use of a single puncture site on more than one occasion. This may lead to bacterial contamination and infection. 􀁸 User error, for example, the use of too much or too little test solution, or capillary blood. 􀁸 Incorrect reading of results. Results should be read immediately following the 20-minute wait time. Results should be discarded if read >5 minutes after the 10-minute wait time as they may be inaccurate.

FAQs

What antibodies does the Fortress Fast test detect?

The test detects SARS-CoV-2 IgG and IgM antibodies. A control line (C) is also used to confirm a valid test result.

How long does it take to read results?

Results should be read in ten minutes. They should be read immediately after the specified waiting time, and discarded if read later than allowed because results may be inaccurate.

What is the limit of detection for the whole blood test?

For whole blood, the limit of detection corresponds to a dilution rate of 1:32.

Oct 4, 2026

Uploaded by PakDamar76