Leptospira IgG/IgM Rapid Test Device

Model RT-107

Lateral flow test for differential detection of IgG and IgM antibodies to Leptospira.

Differentiates IgG from IgM
Serum, plasma or whole blood
Result in 15 to 20 minutes
Stable at 2–36 °C for 24 months

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For in vitro diagnostic use by laboratory and healthcare professionals only. Please refer to the instructions for use supplied with each product for complete protocol and performance details.

Overview

A lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira in human serum, plasma or whole blood, intended as a screening test and as an aid in the diagnosis of Leptospira infection. Any reactive result must be confirmed by an alternative method. Results should not be the sole basis for a clinical decision.

Intended use: Detection and differentiation of IgG and IgM antibodies to Leptospira in human serum, plasma or whole blood.

Specifications

Specifications for Leptospira IgG/IgM Rapid Test Device
Shelf life	24 months
Catalogue number	107
Specimen type	Serum, plasma or whole blood
Specimen volume	1 drop (25 µL) sample plus 2 drops (50 µL) of assay buffer
Storage	2–36 °C
Time to result	15–20 minutes
Sensitivity (manufacturer-stated)	98 %
Specificity (manufacturer-stated)	99.5 %