SENSITIVITY & SPECIFICITY CUSTOMER IS RESPONSIBLE FOR OBTAINING REGULATORY APPROVAL & REGISTRATION UNDER THEIR NAME/BRAND
Respiratory Uncut Sheets
Specification Guidelines
Category
Product Name
Specimen Volume
Testing Time
Specimen
Feature
Certification
NP swab/wash/ aspirate
Sensitivity: 97.44% Specificity: 100% 8-30 mins
Respiratory
Influenza Ag
-
CE-IVD
Sensitivity: 97.67% Specificity: 99.38% LOD: 0.01 μ g/mL
Respiratory
Legionella Ag
Urine
100 μ l
5-15 mins
CE-IVD
Respiratory Adeno Ag
NP swab/Nasal swab NP swab/wash/ aspirate
Respiratory
4 drops
-
15-20 mins
CE-IVD
Sensitivity: 92.45% Specificity: 98.44% 15-30 mins
Respiratory
RSV Ag
-
CE-IVD
Sensitivity: 100% Specificity: 99.26% LOD: 1.56 x 104 CFU/mL Sensitivity: 98.2% Specificity: 99.26% LOD: 3.91 x 105 cells/mL Sensitivity: 100% Specificity: 100% LOD: 2 ng/mL
Respiratory
S. pneumoniae Ag Urine/ CSF
100 μ l
5-10 mins
CE-IVD
Respiratory
Strep A Ag
Throat swab
-
5-15 mins
CE-IVD
Liquid Culture, Solid Culture NP swab/Nasal swab
Respiratory
TB MPT64 Ag
-
10-15 mins
CE-IVD
Respiratory (COVID-19) Respiratory (COVID-19) Respiratory (COVID-19) Respiratory (COVID-19)
COVID/Flu Ag combo 2.0
4 drops
-
15-30 mins
CE-IVD
CE-IVD, WHO EUL, MFDS, TGA, Health Canada
Sensitivity: 95.92-100% (CT: ≤ 25) Specificity: 98.94%
COVID-19 Ag 2.0 NP swab
3 drops
15-30 mins
COVID-19 M/G Ab 2.0 COVID-19 Spike IgG
Sensitivity: 96.82% Specificity: 98.65% 10-15 mins CE-IVD, MFDS
WB/S/P
10-20 μ l
WB: 20 μ l, S/P: 10 μ l
Sensitivity: 100% Specificity: 100% 10-15 mins
WB/S/P
CE-IVD
GI, STD, Hepatitis, Other Uncut Sheets
Specification Guidelines
Category
Product Name
Specimen Volume WB: 20 μ l, S/P: 10 μ l
Testing Time
Specimen
Feature
Certification
Gastrointestinal
H.pylori Ab
WB/S/P
-
10-20 mins
CE-IVD
Sensitivity: 98.5% Specificity: 100% LOD: 0.97 ng/mL
Gastrointestinal
H.pylori Ag
Feces
40-70 mg
10-15 mins
CE-IVD
HIV 1/2 Ab (4-lines) HIV 1/2 Ab (3-lines)
WB: 20 μ l, S/P: 10 μ l WB: 20 μ l, S/P: 10 μ l
Sensitivity: 100% Specificity: 98.8% 10-20 mins
STDs
WB/S/P
-
Sensitivity: 99.8% Specificity: 100% 10-20 mins
STDs
WB/S/P
WHO PQ
* HIV Ab Sensitivity: 100% Specificity: 99.9%* Treponema Pallidum Ab Sensitivity: 98.8% Specificity: 100%
HIV/Syphilis Combo Ab
WB: 20 μ l, S/P: 10 μ l
STDs
WB/S/P
15-20 mins
WHO PQ
WB: 20 μ l, S/P: 10 μ l
Sensitivity: 100% Specificity: 100% 5-20 mins
STDs
Syphilis Ab
WB/S/P
CE-IVD
Sensitivity: 98.5% Specificity: 98% 15-30 mins Sensitivity: 100% Specificity: 98.04% 15-20 mins Sensitivity: 100% Specificity: 100% 20-30 mins
Hepatitis Hepatitis Hepatitis
Anti-HBs
WB/S/P WB/S/P WB/S/P
100 μ l
- - -
HAV IgM Ab
10 μ l
HBsAg
100 μ l
WB: 20 μ l, S/P: 10 μ l
Sensitivity: 100% Specificity: 97.67% 5-20 mins WHO PQ, CE-IVD
Hepatitis
HCV Ab
WB/S/P
Others
Human CRP Ag Leptospira IgM/ IgG Ab
WB/S/P
5 μ l
-
3 mins
CE-IVD
Sensitivity: 96.6% Specificity: 98.6% 15-20 mins
Others
WB/S/P
10 μ l
CE-IVD
Others
Ebola Ag
WB/S/P
100 μ l
-
20-30 mins
CE-IVD
www.meridianbioscience.com/lifescience
WB: Whole Blood. S: Serum. P: Plasma. NP: Nasopharyngeal
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