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| Product Name | Crypto Giardia Rapid Test Kit |
| Catalog No. | DB-1642 |
| Description | The Crypto Giardia test is a rapid immunoassay for the qualitative detection of Cryptosporidium parvum and Giardia lamblia specific antigens in aqueous extracts of human fecal specimens. It is intended for in vitro diagnostic use as an aid in the detection of suspected Cryptosporidium or Giardia infections by professional laboratories. |
| Features | 30T |
| Kit Components | Sample Treatment Buffer: Buffer solution with detergent. WARNING: contains 0.1% azide. Conjugate Reagent A: Biotinylated rabbit anti-Giardia in diluent buffer with carrier protein and detergent. WARNING: contains 0.1% azide. Conjugate Reagent B: Colloidal dye labelled monoclonal antibodies to Crypto Giardia in diluent buffer with carrier protein and detergent. WARNING: contains 0.1% azide. Specimen transfer pipettes. Specimen dilution tubes. |
| Reagent Preparation | Allow kit components and specimens to equilibrate to room temperature before use. Mix liquid reagents by inverting several times before use. Return kit to the refrigerator promptly after each use. Do not unpouch the test devices until ready for use. Several tests may be run at the same time. Use separate dilution tubes and pipettes for each specimen. To prevent possible contamination, avoid touching the dispensing tip of the Sample Treatment Buffer, Conjugate Reagent A and Conjugate Reagent B dropper bottles to the dilution tubes, pipettes, test devices or anything that has come into direct contact with patient specimens. To minimize reagent waste and better control the size of drops dispensed from the reagent bottles, the following steps are suggested: • Store reagent bottles in upright position. • After removing the cap, thoroughly wipe tip with a laboratory wipe making sure all liquid is removed. • Hold bottles in a near vertical position for dispensing. If running multiple samples, allow air to enter the bottle before dispensing drops for the next test. • If liquid is observed on the tip at any time, wipe clean with a lab wipe prior to dispensing drops. • Do not vigorously shake or vortex reagents. Do not concentrate patient specimens. When sampling, use the liquid portion of the specimen. It is recommended that particulates be allowed to settle so that the sample can be more easily pipetted. All fresh or unpreserved specimens, including liquid samples, must be diluted approximately 1:4 in one of the acceptable transport media prior to use with this assay (see Specimen Collection and Handling section). The sequence of reagent additions to the sample tube allows the user to visually monitor the procedure: Sample Treatment Buffer is added to an empty tube; the stool specimen is visually observable; Conjugate Reagent A has a red dye incorporated in it; and Conjugate Reagent B is black in color. |
| Test Procedure | Remove the test device from the pouch and place on a flat surface; place a Specimen Dilution Tube into the kit workstation holder or into a suitable test tube rack. Add two drops of Sample Treatment Buffer to the Specimen Dilution Tube. Use the Specimen Transfer Pipette to aspirate the aqueous patient stool specimen: squeeze the bulb of the pipette, insert the open end into the sample and release the pressure on the bulb while holding the pipette in the sample. Draw sample to the 60 μL calibration line. Transfer the contents of the pipette barrel into the Specimen Dilution Tube. Note: All fresh or unpreserved specimens, including liquid samples, must be diluted approximately 1:4 in one of the acceptable transport media prior to use with this assay (see Specimen Collection and Handling section). If transport media is not available, distilled or deionized water may be used. Mix/Invert Conjugate Reagent A. Add two drops of Conjugate Reagent A to the tube. Mix/Invert Conjugate Reagent B. Add two drops of Conjugate Reagent B to the tube. Mix the sample by manual swirling or by vortexing. Pour the entire contents of the tube into the sample well of the test device. Visually read the test results at 10 min. Results are invalid after 15 minutes. |
| Results | Positive for Cryptosporidium: The presence of grey-black bands at the CRYP and the CONT positions indicates that Cryptosporidium antigen has been detected. Visible test lines, in shades of grey or black only, should be read as positive. The intensity of the grey-black bands can vary from faint to strong. There is no direct correlation between the intensity of the testline with the severity of the infection. Positive for Giardia: The presence of grey-black bands at the GIAR and the CONT positions indicates that Giardia antigen has been detected. Visible test lines, in shades of grey or black only, should be read as positive. The intensity of the grey-black bands can vary from faint to strong. There is no direct correlation between the intensity of the test line with the severity of the infection. Negative for Cryptosporidium: No band is visible at the CRYP position and a visible grey-black band present at the CONT position indicates that Cryptosporidium antigen is absent or is below detectable levels. The GIAR position can have either a visible grey-black band or no grey-black band. Negative for Giardia: No band is visible at the GIAR position and a visible grey-black band present at the CONT position indicates that Giardia antigen is absent or is below detectable levels. The CRYP position can have either a visible grey-black band or no grey-black band. Invalid Results: If no band appears at the CONT position or incomplete or beaded bands appear at the CRYP or GIAR positions, the result is considered invalid. In situations where adequate flow does not occur due to excessive particulate matter in the specimen, the sample can be diluted two-fold in deionized water or in the same transport medium as it was originally collected and re-run. The test should be repeated using another device. Test lines in colors other than grey or black should be considered invalid. Repeat testing using an alternative method or different sample. If an alternative method is used, verify the preservative and the age of the sample is appropriate. |
| Storage and Transportation | Store kit refrigerated 2 to 8ºC (36 to 46ºF) and return kit to the refrigerator promptly after each use. DO NOT FREEZE. |
| Precautions | For in vitro diagnostic Use. Do not use kit beyond the printed expiration date. Handle all patient samples as if they are capable of transmitting infectious disease. Dispose of them properly. Ship samples according to federal regulations regarding the transportation of Infectious agents. Sample treatment buffer, conjugate eeagent A and conjugate reagent B solutions contain sodium azide. Sodium azide may react with lead or copper plumbing to form explosive metal azides. Use copious amounts of water to flush discarded solutions. Do not interchange or mix components from different kit lots. |
For research use only, not for clinical use.
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