Device for rapid detection of tuberculosis-lipoarabinomannan (TB-LAM) with enhanced sensitivity

A method comprising the steps of:

• introducing a source urine sample comprising tuberculosis lipoarabinomannan (TB-LAM) to a rapid diagnostic testing device, the rapid diagnostic testing device comprising:
• a dilutor unit configured to dilute the source urine sample and form a diluted urine sample;
• a pre-concentrator unit configured to concentrate the TB-LAM from the diluted urine sample, comprising:
• an ion-exchange medium comprising one or more ligands configured to capture the TB-LAM from the source urine sample, wherein the captured-TB-LAM is eluted from the ion-exchange medium as an eluate comprising a concentrated form of the TB-LAM;
• a cassette;
• a lateral flow assay unit disposed in the cassette;
• and
• an integration unit attached to the pre-concentrator unit and the cassette, wherein the integration unit comprises a swivel connector coupled to the pre-concentrator unit such that rotation of the pre-concentration unit relative to the cassette causes at least a portion of the pre-concentrator unit to move away from the cassette to transition from an uncoupled position to a coupled position, and
• wherein the cassette is configured to transition from the uncoupled position to the coupled position via rotation of the swivel connector to cause the integration unit to move relative to the pre-concentrator unit, and wherein the integration unit operatively provides a fluidic communication from the pre-concentrator unit to the lateral flow assay unit disposed in the cassette when the pre-concentrator unit and the cassette are coupled to each other;
• and
• detecting a presence of the TB-LAM in the source urine sample.