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The LifeVac is a non-powered, non-invasive, single-use-only airway clearance device intended to resolve choking in a victim with a complete airway obstruction when a current choking protocol has been followed without success. LifeVac should only be used to remove an object/food from a victim with a complete airway obstruction. LifeVac is intended for use on adult or pediatric choking victims who are at least 1 year of age. LifeVac can be administered by a lay person or a medical professional (18 years or older) in various settings including at home or nursing homes, restaurants, schools, and other outside environments.
LifeVac is a portable, non-powered, single-use, non-sterile device that generates suction to remove a complete foreign body airway obstruction from a choking victim after a standard choking rescue protocol has failed. The device consists of a plunger with a one-way valve. A face mask is attached prior to use. The LifeVac device with the attached mask is placed over the victim's nose and mouth creating a mask seal. The device handle is pressed down to compress the unit, which pushes the air out through the vent system on the bottom of the device and not into the patient. The handle is then quickly pulled up and negative pressure is generated to suction out the obstruction. The duration of suction is minimal. The device has a patented ball valve system which is designed to prevent any air from exiting through the mask. The valve also is designed to prevent air from pushing stuck food or foreign objects downward. This creates a one-way suction to remove the lodged object. The device is non-invasive and does not need to be placed into the oral cavity. LifeVac device is available as a Home Kit or Travel Kit. The device is the same in both kit presentations and the only difference is the Home Kit comes with 1 adult mask, 1 pediatric mask, and 1 practice mask while the Travel Kit does not include a practice mask.
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The LIAISON XL MUREX Anti-HDV assay uses chemiluminescence immunoassay (CLIA) technology for the qualitative detection of antibodies to the hepatitis D virus (anti-HDV) in adult human serum, lithium, sodium heparin, and K2-EDTA plasma. The assay is intended as an aid in the presumptive diagnosis of HDV infection in individuals who are HBsAg positive and at risk for HDV infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide evidence of infection with HDV. This test doesnot determine the state of infection or associated disease.
The test must be performed on the LIAISON XL Analyzer.
The LIAISON XL MUREX Control Anti-HDV (negative and positive) are intended for use as assayed quality control samples to monitor the performance and reliability of LIAISON XL MUREX Anti-HDV assay. The performance characteristics of LIAISON XL MUREX AntiHDV controls have not been established for any other assays or instrument platforms different from LIAISON XL Analyzer.
The LIAISONXL MUREX Anti-HDV is an in vitro diagnostic device consisting of five (5) reagents provided in individual compartments within a plastic container called Reagent Integral. The assay configuration allows for the performance of 100 tests.
Reagent Integral Composition
Table 1: Reagent Integral Composition:
| Component | Description |
|---|---|
| Magnetic particles (2.45 mL) | Magnetic particles coated with biotinylated recombinant HDAg (obtained in E. coli), streptavidin, BSA, phosphate buffer, < 0.1% sodium azide. |
| Calibrator 1 (0.7 mL) | BSA, phosphate buffer, EDTA, 0.2% ProClin™ 300, an inert yellow dye. |
| Calibrator 2 (0.7 mL) | Diluted and inactivated serum/plasma containing low anti-HDV levels, BSA, phosphate buffer, EDTA, 0.2% ProClin™ 300, an inert blue dye. |
| Specimen diluent (25 mL) | BSA, casein, borate buffer, EDTA, 0.2% ProClin™ 300, detergents and preservative. |
| Conjugate (23 mL) | Mouse monoclonal IgG to human IgG and Mouse monoclonal IgG to human IgM conjugated to an isoluminol derivative, non-specific IgG (mouse polyclonal), BSA, phosphate buffer, 0.2% ProClin™300, preservatives, an inert blue dye. |
All reagents are supplied ready to use. The order of reagents reflects the layout of containers in the Reagent Integral.
Additionally required materials
LIAISON XL MUREX Control Anti-HDV is quality control material provided in a separate box consisting of 2 levels of controls (2 control levels x 2 vials x 1.0 mL, ready to use). Each control vial allows at least 20 tests to be performed. Quality control should be performed once per day of use. Follow applicable government or local regulations for quality control.
Table 2: LIAISON XL MUREX Control Anti-HDV set Composition:
| Component | Description |
|---|---|
| Negative control (2 x 1.0 mL) | Human serum/plasma non-reactive for HDV antibodies, 0.2% ProClin™ 300, preservatives. |
| Positive control (2 x 1.0 mL) | Inactivated human serum/plasma reactive for HDV antibodies, 0.2% ProClin™ 300, preservatives. |
Materials required but not provided with the device
LIAISON XL Analyzer
LIAISON XL Analyzer (Model I0050), is a fully automated system with continuous loading combining the chemiluminescence technology with magnetic microparticles as solid phase. The LIAISON XL Analyzer performs the complete sample processing (sample pre-dilutions, sample and reagent dispensing, incubations, wash processes) as well as the measurement and evaluation.
The addition of the Workcell Upgrade Kit extends the sampling arm to allow for connection to any third-party laboratory automation having compatible connection capability for the performance of pre- and post-analytical sample handling processes. The LIAISON XL Workcell Upgrade Kit also maintains the LIAISON XL Analyzer's performance as a stand-alone instrument.
To perform the assay, the following materials are needed in addition to the specific assay Reagent Integrals:
- LIAISON XL Cuvettes (code X0016).
- LIAISON XL Disposable Tips (code X0015)
- LIAISON XL Starter Kit (code 319200)
- LIAISON XL Wash/System Liquid (code 319100)
- LIAISON XL Waste Bags (code X0025).
B Principle of Operation
The method for the qualitative determination of specific antibodies to hepatitis D virus (HDV) is an indirect chemiluminescence immunoassay (CLIA). The recombinant antigen specific for HDV is used for coating magnetic particles (solid phase). During the first incubation, the HDV antibodies present in the calibrator, samples or controls bind to the solid phase through the recombinant HDV antigen. During the second incubation, mouse monoclonal antibodies to human IgG and mouse monoclonal antibodies to human IgM, both linked to an isoluminol derivative (isoluminol-antibody conjugate), react with antibodies to HDV already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and indicates the presence or absence of antibodies to HDV presence in the calibrator, samples, or controls.
LIAISON XL MUREX Anti-HDV results are reported as Index value, which is used for sample grading to provide a qualitative reportable result. The Index value is calculated by dividing the signal generated by the analyzer (relative light units, RLU) to a value obtained by multiplying the calibrator mean signal (RLU) per an "a" coefficient. The 'coefficient a' is the factor by which the Cut-off can be optimized to achieve the required balance of assay specificity and sensitivity, to obtain a correct sample.
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