Crypto and Giardia Combo Test

Intended Use

Crypto and Giardia combo Test is an in vitro immunoassay for the direct and qualitative detection of Cryptosporidum and Giardia lamblia from human feces. Crypto and Giardia combo Test is intended to aid in the rapid diagnosis of Cryptosporidiosis and Giardiasis.

Introduction

Giardiasis:

Giardiasis, caused by Giardia lamblia (also known as G. intestinalis), is one of the most common parasitic human diseases globally. In 2013, there were about 280 million people worldwide with symptomatic giardiasis. Rates are as high as 7% in the developed world and 30% in the developing world. The World Health Organization classified it as a neglected disease.

Giardia usually spreads when G. lamblia cysts within feces contaminate food or water which is then eaten or drunk. It may also spread between people and from other animals. Cysts may survive for nearly three months in cold water. Symptoms are caused by Giardia organisms infecting the cells of the duodenum and jejunum of the small intestine and blocking nutrient absorption. Most people are asymptomatic; only about a third of those infected exhibit symptoms. If the infection is not treated, these symptoms may last for six weeks or more.

For diagnosis of Giardiasis, the traditional basis is identification of G. lamblia trophozoites or cycsts via a stool ova and parasite examination. PCR can be used to identify the subtypes of Giardia. Stool culture is not routinely used because of the difficulty of reproducibly isolating Giardia from patient fecal samples. However, stool cultures are beneficial in ruling out other pathogens as the cause of a patient's symptoms. Stool antigen ELISA, IFA, or rapid test may be helpful, if the results from 3 O&P tests are negative and Giardiasis is still suspected.

Materials

● Individually packed test devices

● Package insert

● Sample dilution tube with buffer

● Disposable droppers

Test Procedure

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Specimen collection and pre-treatment:

1) Use clean, dry specimen containers for specimen collection. Best results will be obtained if the assay is performed within 2 hours after collection.

Note: Specimens collected in the specimen container may be stored for 3 days at 2~8oC or for 6 months at -20°C.

2) For solid specimens: Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 120 mg of feces.

For liquid specimens: Hold the pipette vertically, aspirate fecal specimens, and then transfer 3 drops (approximately 120 uL) of the liquid specimen into the sample diluent tube.

3) Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.

4) Shake the specimen collection tube to mix the specimen and the diluent buffer thoroughly.

2. Testing

1) Remove the test device from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within 2 hours.

2) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2 drops of solution into the specimen well (S) of the test device.

Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.

3) Wait for the colored band(s) to appear. The result should be read at 10 minutes.

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