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GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual
1.4 Principle of Procedure
The information below describes the principle of procedure for those tests enabled on your reader.
Microchip electrophoresis: Gazelle Hb Variant uses a miniaturized version of the gold standard test for hemoglobinopathy
detection known as electrophoresis. When a disposable cartridge (from the Hb Variant Test Multipack) containing a lysed
blood sample (20 µL) is inserted into the Reader, the hemoglobin types are separated according to their charge. In about 8
minutes, the interpretation (normal, trait, disease) as well as the types and percentages of hemoglobin are displayed on the
screen and stored digitally.
Gazelle separates hemoglobin types in a small volume of blood on a piece of cellulose acetate paper that is housed in a
cartridge. The basis of Gazelle’s technology lies in hemoglobin electrophoresis, in which different hemoglobin types,
including A (normal), S (sickle), C (hemoglobin C disease), A2, E (hemoglobin E disease), and F (fetal) have different net
negative charges in an alkaline solution and move across the paper at different speeds due to an applied voltage. The
different hemoglobin types separate into visible bands on the paper. The image analysis algorithm extracts the image
characteristics of the hemoglobin bands to determine the type of hemoglobin as well as its relative amount. This information
is used to offer an interpretative statement based on hemoglobin proportions.
COVID-19 Fluorescent immunoassay: Gazelle works in conjunction with the Gazelle PathoCatch™ COVID -19 Test Cassette’s
fluorescent immunoassay technology to detect COVID-19. The Gazelle™ PathoCatch™ COVID -19 Test Cassette for SARS-CoV-2
antigen employs immunofluorescence technology in a sandwich design that is used with the Gazelle Reader to detect SARS-
CoV-2 nucleocapsid protein. The nucleocapsid protein in the nasal sample combines with the fluorescently labeled SARS-
CoV-2 antibody to form a complex, which is subjected to chromatography. The complex moves forward through the
nitrocellulose membrane to the SARS-CoV-2 detection line (T line). The complex is captured by the SARS-CoV-2 antibody-
coated detection line to form the final reaction, making the detection line (T line) visible to the Gazelle Reader. An internal
procedure control band will appear at the control line (C line) region for each test if the test was conducted properly.