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QUALITY

ASSURANCE

WHAT IS THE PRINCIPLE BEHIND TUBEX AND HOW DOES IT DETECT ANTIBODIES AGAINST S. TYPHI?
TUBEX detects the presence of anti-O9 antibodies in the patients serum by assessing their ability to inhibit the reaction between the antigen-coated brown and antibody-coated blue reagents. The level of inhibition is proportional to the concentration of anti-O9 antibodies in the sample. Separation is enabled by magnetic force. Result is read visually against a color scale.

WHAT TYPE OF ANTIBODIES AGAINST S. TYPHI IS DETECTED BY TUBEX?


TUBEX detects the presence of anti-O9 antibodies in the patients serum.

WHAT TYPE OF SPECIMEN MAY BE USED IN THE TEST?


Clear serum sample or heparin plasma may be used in TUBEX.

DO ANTICOAGULANTS INTERFERE WITH THE TEST?


EDTA and citrated plasma are not allowed in the test. The only allowable specimen with anticoagulant is heparinized plasma.

WHAT ARE THE CONTENTS OF EACH REAGENT AND WHAT ARE THEIR PURPOSES?
TUBEX Blue Reagent - antibody coated particles in protein stabilized buffer TUBEX Brown Reagent - antigen coated particles in protein stabilized buffer TUBEX Negative Control - protein stabilized buffer TUBEX Positive Control - control antibody in protein stabilized buffer

WHAT IS THE PURPOSE OF FIRST INCUBATION? HOW ABOUT THE SECOND INCUBATION?
First and second incubation are done in order to allow the reactions between the antigens and antibody to take place.

WHAT IS THE CORRECT WAY OF SHAKING THE WELL?


The correct way of shaking the well is by holding the reaction well strip across at one end (well number face-front) using one hands thumb and fore nger then tilt the reaction well strip horizontally to expose maximum well surface for the mixture. Shake the reaction well strip rapidly backwards and forwards.

WHAT IS THE PURPOSE OF TILTING THE WELL 90 DEGREES WHILE SHAKING LATERALLY AFTERWARDS?
This is to ensure that the contents ow across the entire exposed surface of the well and that vigorous shaking is observed.

WHAT MAY HAPPEN IF THE INCUBATION TIME IS LESSENED OR GREATER?


Any discrepancy in the procedure may produce erroneous results.

WHAT MAY HAPPEN IF THE LATERAL SHAKING TIME IS BELOW 2 MINUTES OR GREATER THAN 2 MINUTES?
Undertime or overtime shaking may alter results. For below 2 minutes shaking, the reaction may not fully take place while overtime shaking might also produce discrepant results.

WHAT IS THE PURPOSE OF THE MAGNETIC COLOR SCALE?


The magnetic color scale is used for the separation between the antigen-coated brown reagent and antibody-coated blue reagent.

HOW SENSITIVE IS TUBEX IN THE DETECTION OF S. TYPHI ANTIBODIES?


TUBEX speci cally detects IgM antibodies to the S. typhi O9 lipopolysaccharide antigen. This antigen is highly speci c to S. typhi and other Salmonella serogroup D bacteria by its extremely rare sugar. IgM anti-O9 antibodies are normally not present in healthy individuals. No detectable cross reactivity to antibodies of other speci cities prevails.