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GI, STD, Hepatitis, Other Uncut Sheets
Specification Guidelines
Category
Product Name
Specimen Volume
Specimen
Feature
Testing Time Certification
Chikungunya IgM Ab
Vector-borne
-
-
-
-
-
Chikungunya IgM/IgG Ab
Sensitivity: 97.7% Specificity: 99.6% 15-20 mins
Vector-borne
WB/S/P
10 μ l
CE-IVD
Dengue IgM/IgG Ab
Sensitivity: 97.5% Specificity: 97.2% 15-20 mins
Vector-borne
WB/S/P
10 μ l
CE-IVD
Vector-borne Dengue IgM Ab
-
-
-
-
-
Sensitivity: 92.9% Specificity: 98.7% LOD: 0.5 ng/mL
Vector-borne Dengue NS1 Ag
WB/S/P
100 μ l
15-20 mins
CE-IVD
Sensitivity: 100% Specificity: 100% 10-20 mins
Vector-borne
Filariasis Ag
WB/S/P
2 drops
CE-IVD
Tsutsugamushi IgM/IgG Ab Yellow Fever IgM Ab Yellow Fever IgM/ IgG Ab
Vector-borne
WB/S/P
10 μ l
-
15-20 mins
CE-IVD
Sensitivity: 100% Specificity: 98.3% 15-20 mins
Vector-borne
WB/S/P
10 μ l
CE-IVD
Vector-borne
-
-
-
-
-
Sensitivity: 98% Specificity: 100% 15-20 mins
Vector-borne
Zika IgM Ab
WB/S/P WB/S/P
10 μ l 10 μ l
CE-IVD CE-IVD
Vector-borne Zika IgM/IgG Ab
-
15-20 mins
* Venous Whole Blood Sensitivity: 99.59% Specificity: 100% * Capillary Whole Blood Sensitivity: 99.38% Specificity: 100%
Vector-borne
Malaria P.f Ag
WB
5 μ l
15-30 mins CE-IVD, WHO PQ
WB: 20 μ l, S/P: 10 μ l
Sensitivity: 97.6% Specificity: 96.9% 5-20 mins
Vector-borne Malaria P.f/P.v Ab
WB/S/P
-
* Venous Whole Blood Sensitivity: P.f 99.59%, P.v 100% Specificity: 100% * Capillary Whold Blood Sensitivity: P.f 99.38%, p.v 100% Specificity: 100% * Venous Whole Blood Sensitivity: P.f 99.58%, P.v, P.m. and P.o. confirmed specimen on pan
Vector-borne Malaria P.f/P.v Ag
WB
5 μ l
15-30 mins CE-IVD, WHO PQ
100% Specificity: 100% * Capillary Whold Blood
Malaria P.f/pan Ag
Vector-borne
WB
5 μ l
15-30 mins CE-IVD, WHO PQ
Sensitivity: P.f 99.68%, P.v, P.m. and P.o. confirmed specimen on Pan 100% Specificity: 100%
WB: Whole Blood. S: Serum. P: Plasma. NP: Nasopharyngeal
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Email: info@meridianlifescience.com Orders: orders@meridianlifescience.com www.meridianbioscience.com/lifescience
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03/23
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