PROFARMA UAB is a GMP certified company for the batch release testing of medicinal drug products, active pharmaceutical ingredients and medical devices, imported into EU countries.
PROFARMA is a GMP certified biopharmaceutical company in Lithuania, specialising in batch release testing of medicinal drug products, active pharmaceutical ingredients and medical devices, imported into EU countries. Company has EMA approved laboratories for conformity testing of medications imported into EU countries.
PROFARMA evaluated different suppliers for a rapid diagnostic SARS-CoV-2 test, selected and qualified the most reliable supplier.
The Rapid COVID-19 Test is based on mmunochromatographic separation of IgG / IgM specific antibody pair and their identification. This test detects both early marker and late marker, IgM/IgG antibodies in human finger-prick or venous blood samples It is a simple, fast and selective method which can be used for initial screening and evaluation of the SARS-CoV-2 family viruses. Test can be used for rapid screening of carriers of the virus that are symptomatic or asymptomatic. It is important to stress, that test provides only a preliminary test result. Therefore, any reactive specimen with the 2019-nCoV IgG/IgM Rapid Test Cassette must be confirmed with alternative testing method(s) and clinical findings.
The test uses anti-human IgM antibody, anti-human IgG and goat anti-rabbit IgG immobilised on a nitrocellulose strip. The burgundy colored conjugate pad contains colloidal gold conjugated to recombinant COVID-19 antigens conjugated with colloid gold and rabbit IgG-gold conjugates. When a specimen followed by assay buffer is added to the sample well, IgM &/or IgG antibodies if present, will bind to COVID-19 antigens conjugates making antigen antibodies complex. This complex migrates through nitrocellulose membrane by capillary action. When the complex meets the line of the corresponding immobilized antibody (anti-human IgM &/or anit-human IgG) the complex is trapped forming a burgundy colored band which confirm a reactive test result. Absence of a colored band in the test region indicates a non-reactive test result.
The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid and the specimen must be retested with another device.
The main advantages of express test:
· Fast: the answer YES/NO is received within 15 minutes.
· Reliable: sensitivity >85%, specificity >90%
· Test is based on the identification of the pair of antibodies (IgG / IgM), so infection can be diagnosed from day 4 of infection.
· Each batch of the kits are tested and approved by a GMP certified laboratory before being placed on the market.
V. A. Graičiūno g. 8, LT-02241 Vilnius, Lithuania.