Giardia Lamblia Rapid Test Cassette 10 Minutes Reading

Giardia Lamblia Rapid Test Cassette (Feces),trophozoite and cysts,detection of Giardia lamblia antigen

APPLICATION

PRINCIPLE

Giardia lamblia Rapid Test Cassette is a lateral flow immunochromatographic assay based on sandwich format. The test cassette have two testing windows. During testing, sample is applied into the sample well on the cassette. Giardia antigens, if present in the specimen, react with anti-Giardia antibodies coated colloidal gold particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with anti Giardia antibodies on the membrane in the test line region. If the specimen contains Giardia antigen, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain Giardia antigens, a colored line will not appear in the test line region indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

STORAGE AND STABILITY

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30 °C). The test is stable through the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

MATERIALS

Materials Provided

• Test cassettes

• Droppers

• Package insert

• Specimen collection tubes with extraction buffer

Materials Required but Not Provided

• Timer

• Specimen collection containers

DIRECTIONS FOR USE

Allow the test cassette, specimen, buffer, and/or controls to equilibrate to room temperature (15-30 °C) prior to testing.

1. Collect sufficient quantity of feces (1-2mL or 1-2g) in a clean, dry specimen collection container to obtain enough pathogens. Best results

will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8°C if not tested

within 6 hours. For long term storage, specimens should be kept below -20°C.

To process fecal specimens:

• For Solid Specimens:

Unscrew the cap of the specimen collection tube, then randomly stab the specimen collection applicator into the fecal specimen at least 3 different sites to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.

• For Liquid Specimens:

Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops of the liquid specimen (approximately 80 µL) into the specimen

collection tube containing the extraction buffer. Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the collection tube for reaction for 2 minutes.

2. Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it as soon as possible. Best

results will be obtained if the test is performed immediately after opening the foil pouch.

3. Hold the specimen collection tube upright and unscrew the tip of the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80 µL) to each specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.

4. Read the results at 10 minutes after dispensing the specimen. Do not read results after 20 minutes.

Note: If the specimen does not migrate (presence of particles), centrifuge the diluted sample contained in the extraction buffer vial. Collect 160 µL

of supernatant, dispense into the specimen well (S) of a new test cassette and start afresh following the instructions mentioned above.

INTERPRETATION OF RESULTS

Positive: The presence of both C line and T line, regardless of T line being strong or faint.

Negative: Only clear C line appears.

Invalid: No colored line appears in C zone, regardless of T line’s appearance.

HANGZHOU ALLTEST BIOTECH CO.,LED has a solid foundation with top-notch industry professionals, having proven expertise in innovation management including new introductions, be it a product or be it industry transforming process developments. We have been witness to as well as been part of core teams that have been responsible for transformations, which are critical today’s Rapid Tests as well as POCT business.

Some of them include industry-leading design control systems that are responsible for innovative products with high quality as well as validations protocols that form the core of stringent quality assessment systems.

HANGZHOU ALLTEST BIOTECH CO.,LTD has been created with the sole objective of benefitting the stakeholders in healthcare industry with major stake in POCT business including rapid tests.

HANGZHOU ALLTEST BIOTECH CO.,LTD is committed to bring Innovative Solutions including convergence of rapid test’ ease with the power of modern day electronics, thereby helping the creation of new technological platforms as well as business processes that unlocks the true potential of amalgamation of technology and commerce with new milestones in techno-commercial sectors of POCT industry.

In a nutshell, with HANGZHOU ALLTEST BIOTECH CO.,LTD, you can “Relax” and leave the worries of today and tomorrow with better solutions for you than solutions available today.