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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma)

Manufactured by Acro Biotech Inc, United States - www.acrobiotech.com 

Device identification number
2412
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
IgG, IgM
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Parainfluenza Virus Type 2, Parainfluenza Virus Type 3
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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), C.36 P.1 (Gamma), P.2 (Zeta), P.3 (Theta), C.37 (Lambda), B.1.616 B.1.526.1 B.1.526.2
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 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 SARSCoV-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-COV2/ 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
15 minutes
Subclass
Sandwich
LOD
100 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.085 % IgM ((Mycoplasma pneumoniae IgM))
Fp
% IgG 0(COVID-19 IgG ),
Fp
0.78 % IgG ((Mycoplasma pneumoniae IgG),)
Fp
0.15 % IgM ((COVID-19 IgM),)
Fn
% IgG 0.02(COVID-19IgG )
Fn
0.052 % IgM ((Mycoplasma pneumoniae IgM))
Fn
0.054 % IgG ((Mycoplasma pneumoniae IgG))
Fn
0.04 % IgM ((COVID-19 IgM))
Precision
Evaluated
Accuracy
93.7 % IgM ((Antigen)(Mycoplasma pneumoniae IgM))
Accuracy
93.7 % IgG ((Antigen)(Mycoplasma pneumoniae IgG),)
Accuracy
92.9 % IgM ((Antigen)(COVID-19 IgM),)
Accuracy
98.6 % IgG ((Antigen)(COVID-19 IgG ))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG ((Antigen)(COVID-19 IgG ),)
Clinical Sensitivity
85 % IgM ((Antigen)(COVID-19 IgM),)
Clinical Sensitivity
92.2 % IgG ((Antigen)(Mycoplasma pneumoniae IgG),)
Clinical Sensitivity
91.5 % IgM ((Antigen)(Mycoplasma pneumoniae IgM))
Clinical Specificity
98 % IgG ((Antigen)(COVID-19 IgG ),)
Clinical Specificity
96 % IgM (Antigen)(COVID-19 IgM),)
Clinical Specificity
94.6 % IgG ((Antigen)(Mycoplasma pneumoniae IgG),)
Clinical Specificity
94.8 % IgM ((Antigen)(Mycoplasma pneumoniae IgM))
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