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Giardia lamblia Test
Giardia lamblia Feces Test Cassette

Catalog No.          Product Name               

ABT-IDT-B255    Giardia lamblia Feces Test Cassette

INTENDED USE

ACCU-TELL® Rapid Giardia Lamblia Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Giardia Lambliaantigenin human feces specimen.

PERFORMANCE CHARACTERISTICS

A.Detection Limit

The detection limit was evaluated by diluting a pure cysts solution (625,000 cysts/mL) and the results show that the number of cysts detected is 3,125 cysts/mL.

B.Sensitivity - Specificity

1) ACCU-TELL® Rapid Giardia Lamblia Test Cassette (Feces) was evaluated on 396 patients. The status of the samples was checked after concentrationof parasites (Ritchie method) and microscopic slide reading.

Method

Microscopic

Total Result

ACCU-TELL® Rapid Giardia Lamblia Test Cassette (Feces)

Results

Positive

Negative

Positive

77

7

84

Negative

3

309

312

Total Result

80

316

396

Relative sensitivity: 96.2% (95%CI*: 89.4%~99.2%);  

Relative specificity: 97.8% (95%CI*:95.5%~99.1%);

Accuracy: 97.5% (95%CI*: 95.4%~98.8%).            

*Confidence Intervals

C.Repeatability and reproducibility

To check intra-batch accuracy (repeatability), the same positive samples and a buffer solution were processed 15 times on kits of the same production batch in the same experimental conditions. All observed results were confirmed as expected.

To check inter-batch accuracy (reproducibility), some samples (positive and buffer) were processed on kits from three different production batches. All results were confirmed as expected.

D.Interference

Cross-reactivity to samples positive for the following pathogens was tested and found to be negative: Salmonella typhimurium, Coronavirus, several E. coli strains (including E. coli O157:H7 and E. coli c600-933W), Rotavirus, Adenovirus, Cryptoposridiumparvum, E.coli F5, Salmonella enteritidis, Chylomastixmesnilii, Entamoeba coli, Endolimaxnanus, Blastocystishominis, Rhabditis larvae, Enterobiusvermicularis, Strongyloidesstercoralis, Hymenolepis nana, isospora belli, Entamoebahartmanii, Entamoebahisto/dispar, Enterobiusvermicularis, Isosporahominis.

Tests for cross-reactivity has been tested on Staphylococcus aureus and found positive at high bacteria concentrations.

 

LIMITATIONS

The test is qualitative and cannot predict the quantity of antigens present in the sample. Clinical presentation and other test results must be taken into consideration to establish diagnosis.

A positive or negative test result does not rule out the possibility that other pathogens may be present.

This test is an acute-phase screening test. Specimens that are collected after this phase may contain antigen titres below the test’s sensitivity threshold. If a sample tetsnegative, despite the observed symptoms, further testing with alternative methods are recommeneded.