COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma)
Manufactured by CITEST DIAGNOSTICS Inc., Canada - www.citestdiagnostics.com
Device identification number
2436
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Enterovirus A71 (EV-A71), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV)
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. The COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARS-CoV-2/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. The product is intended for use by trained laboratory personnel. The test provides preliminary test results. Negative results will not preclude SARS-COV-2/ M.pneumoniae infection and they cannot be used as the sole basis for treatment or other management decision. False positive results for IgM and IgG antibodies may occur due to cross- reactivity from pre-existing antibodies or other possible causes.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
100 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 AU (COVID19 IgG),
False positives
0.085 AU ((Mycoplasma pneumoniae IgM))
False positives
0.078 AU ((Mycoplasma pneumoniae IgG),)
False positives
0.15 AU ((COVID19 IgM),)
False negatives
0.02 AU ((COVID19 IgG),)
False negatives
0.052 AU ((Mycoplasma pneumoniae IgM))
False negatives
0.054 AU ((Mycoplasma pneumoniae IgG),)
False negatives
0.04 ((COVID19 IgM),)
Precision
Evaluated
Accuracy
93.7 % IgG ((Mycoplasma pneumoniae), )
Accuracy
95 % IgM ((Mycoplasma pneumoniae))
Accuracy
98.6 % IgG ((COVID-19 ))
Accuracy
92.9 % IgM ((COVID-19), )
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG ((COVID-19), )
Clinical Sensitivity
85 % IgM ((COVID-19), )
Clinical Sensitivity
92.2 % IgG ((Mycoplasma pneumoniae), )
Clinical Sensitivity
91.5 % IgM ((Mycoplasma pneumoniae))
Clinical Specificity
98 % IgG ((COVID-19), )
Clinical Specificity
96 % IgM ((COVID-19), )
Clinical Specificity
94.6 % IgG ((Mycoplasma pneumoniae),)
Clinical Specificity
94.8 % IgM ((Mycoplasma pneumoniae))
Type of antigen
nucleoprotein
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements