Table 1.
Commercial diagnostic assays for the detection of protozoa, either approved by the FDA or registered for selling in the European Union, having the CE seal of European Conformity or Conformité Européenne
| Product Name | Manufacturer, Country | Sensitivity (%) | Specificity (%) | Approval |
|---|---|---|---|---|
| 1.A. Cryptosporidium | ||||
| A. Immunofluorescence assays | ||||
| Crypto-Cel IF Test | Celllabs, AUS | 100 | 100 | FDA/CE |
| B. Enzyme immunoassays | ||||
| Cryptosporidium II TEST(direct Ag/spectrophotometric/visual) | Alere/Techlab, Inc USA | 97 | 100 | FDA |
| Prospect Cryptosporidium Rapid Assay | Thermo Fisher Scientific/REMEL, USA | 100 | No data | FDA |
| RIDASCREEN Cryptosporidiuma | R-Biopharm, Germany | 100 | 97.3 | CE |
| PARA-TEC Cryptosporidium | Medical Chemical Corporation, USA | 100 | 100 | CE |
| C. Immunochromatographic/point-of-care assays | ||||
| UNI-GOLD Cryptosporidium | Trinity Biotech, Ireland/USA | 100 | 100 | FDA/CE |
| XPECT Cryptosporidium LATERAL FLOW ASSAY, MODEL 2451020 | Thermo Scientific REMEL, USA | 96.4 | 98.3 | FDA |
| Cryptosporidium Fecal ELISA Test | Cortez Diagnostics, USA | 100 | 100 | FDAa/CE |
| Crypto-Strip C-1005 (CRYPTO UNI-STRIP, CRYPTO-CIT)a | Coris BioConcept, Belgium | 95.7 | 100 | CE |
| RIDA Quick Cryptosporidium (dipstick or cassette)a | R-Biopharm, Germany | 93.8 | 100 | CE |
| CRYPTO (card and blister formats)a | CerTest Biotec, Spain | 99 | 99 | CE |
| Stick Cryptoa | Operon, Spain | 79.3 | 99.5 | CE |
| D. PCR-based assays | ||||
| KHCRYP (real-time PCR) | CEERAM S.A.S., France | No data | No data | CE |
| 1.B. Giardia duodenalis | ||||
| A. Immunofluorescent assays | ||||
| Giardia-Cel IF Test | Cellabs, Australia | 90.3 | 100 | FDA/CE |
| B. Enzyme immunoassays (antigen detection) | ||||
| Giardia lamblia ANTIGEN DETECTION MICROWELL ELISA | Ivd Research, Inc USA | 100 | 100 | FDA |
| TechLab Giardia II TEST | Techlab Inc/Alere USA | 100 | 100 | FDA |
| Giardia ELISA kit | Cortez Diagnostics, USA | 100 | 100 | FDAa/CE |
| ProSpecT Giardia Microplate Assay (direct Ag/spectrophotometric/visual) | Thermo Fisher Scientific/REMEL, USA | 97 | No data | FDA |
| ProSpecT Giardia EZ Microplate Assay | Thermo Fisher Scientific/REMEL, USA | 97 | No data | FDA |
| RIDASCREEN Giardiaa | R-Biopharm, Germany | 100 | 99.60 | CE |
| PARA-TEC Giardia lamblia | Medical Chemical Corporation, USA | 85 | 97.9 | CE |
| C. Immunochromatographic/point-of-care diagnostics | ||||
| Uni-Gold Giardia | Trinity Biotech, Ireland | 100 | 100 | CE |
| Stick Giardiaa | Operon, Spain | 93.8 | 98.9 | CE |
| Giardia lamblia (Giardia)a | CerTest Biotec, Spain | 97 | 99 | CE |
| Giardia (dipstick and cassete) | Coris BioConcept, Belgium | 96.3 | 97.8 | CE |
| D. Molecular assays | ||||
| Giardia Test Kit KHGIAR | CEERAM S.A.S., France | No data | No data | CE |
| 1.C. Dual detection: Cryptosporidium spp (C) and Giardia duodenalis(G) | ||||
| A. Immunofluorescent microscopy assays | ||||
| Crypto/Giardia-Cel IF Test | Cellabs, Australia | 100 | 100 | FDA/CE |
| MERIFLUOR Cryptosporidium/Giardia | Meridian Biosciences, USA | 100 | 100 | FDA |
| PARA-TECT Cryptosporidium/Giardia DFA 75Test Kit | Medical Chemical Corporation, USA | 100 | 100 | CE |
| IVD Crypto/Giardia DFA | IVD Research, Inc, USA | 100 | 100 | FDA |
| B. Enzyme immunoassays (antigen detection) | ||||
| Giardia/Cryptosporidium QUIK CHEK test | Techlab Inc/Alere, USA | C-100, G-98.9 | C-99.8, G-100 | FDA |
| Giardia/Cryptosporidium CHEK | Techlab Inc/Alere, USA | 97.6 | 100 | FDA |
| Crypto/Giardia Ag Combo ELISA kit | Cortez Diagnostics, USA | 99 | 100 | CE/FDAa |
| ProSpecT Giardia/Crypto (spectrophotometric) | Thermo Fisher Scientific, USA | 100 | 95 | FDA |
| C. Immunochromatographic/point-of-care assays | ||||
| XPECT Giardia/Cryptosporidium | Thermo Scientific REMEL, USA | C-96.4, G-95.8 | C-98.5, G-98.5 | FDA |
| Biosite Triage Parasite Panel | Alere/Biosite Incorporated, USA | C-91.4, G-95.1 | C-98.2, G-88.4 | FDA |
| ColorPAC Giardia/Cryptosporidium Rapid Assay | Becton Dickinson, USA | C-97.3, G-100 | C-100, G-100 | FDA |
| Crypto/Giardia Duo-Stripa | Coris BioConcept, Belgium | C-95.7, G-96.3 | C-100, G-97.8 | CE |
| ImmunoCard STAT! Cryptosporidium/Giardia Rapid Assay | Meridian Bioscience, USA | C-97.3, G-100 | C-100, G-100 | CE |
| RIDA Quick Cryptosporidium/Giardia Combi (dipstick or cassette)a | R-Biopharm, Germany | C-93.8, G-100 | C-100, G-95.2 | CE |
| RIDAQuickb Cryptosporidium/Giardia/Entamoeba Combi (dipstick or cassette)a | R-Biopharm, Germany | C-83, G-91.9 | C-93.3, G-99.5 | CE |
| CRYPTO-GIARDIA (card and blister)a | CerTest Biotec, Spain | C-99, G-97 | C-99, G-99 | CE |
| CRYPTO-GIARDIA-ENTAMOEBAa,b | CerTest Biotec, Spain | C-99, G-97 | C-99, G-99 | CE |
| Stick Crypto-Giardiaa | Operon, Spain | C-79.3, G-93.8 | C-99.5, G-98.9 | CE |
| 1.D. Molecular assays for detection of multiple enteric pathogens | ||||
| Film Array Instrumentc | Biofire Diagnostics, USA | FDA/CE | ||
| xTAG Gastrointestinal Panel (GPP)d | Luminex, USA | C-100, G-100 Cyclospora-100 |
C-99.6, G-99.5 Cyclospora-100 |
FDA/CE |
a
Not available in the United States.
b
Also for Entamoeba spp.
c
Multiplex assay including bacterial and viral pathogens.
d
Multiplex assay including the protozoa Cyclospora cayetanensis, plus bacterial and viral pathogens.
Data from Catalog of cleared and approved medical device information from FDA. Database of approved in-vitro diagnostic devices. 2014. Accessed October 20, 2014.