DPP ZCD IgM/IgG System/pack 20

General description:
The DPP ZCD IgM/IgG (Zika/Chikungunya/Dengue IgM/IgG) Assay System is a single-use rapid immunochromatographic test intended for the detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to Zika Virus (ZIKV); the detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to chikungunya Virus (CHIKV); and the detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to dengue Virus (DENV) in fingerstick whole blood, EDTA venous whole blood, serum, or EDTA plasma samples. It is intended for use in clinical and point-of-care (POC) settings to aid in the diagnosis of infection with ZIKV and/or CHIKV and/or DENV only in patients with clinical symptoms. Results must be confirmed by using ANVISA or local guidelines for diagnosis of these arboviral diseases.

Technical specifications:
The Chembio DPP ZCD IgM/IgG Assay System includes the DPP ZCD Test Devices and other components as well as a DPP Micro Reader. The device employs Chembio’s patented DPP (Dual Path Platform) technology and consists of a sample path that distributes sample onto two assay paths, which include antibody detection TEST (1,2,3) and CONTROL (C) areas in each readout window of the test cassette. The top test strip (window labeled 1, 2, 3) is for the detection of IgM antibodies to DENV, ZIKV and CHIKV and the bottom test strip (window labeled 1, 2, 3) is for the detection of IgG antibodies to DENV, ZIKV and CHIKV.
Sample type: Fingerstick whole blood, venous blood, serum, plasma
Sample volume: 10µl
Time to results: 15-20 mins from start of the test
Sensitivity:
79.00% for Zika IgM
95.60% for Zika IgG
90.00% for Dengue IgM
81.80% for Dengue IgG
90.60% for CHIKV IgM
96.90% for CHIKV IgG

Specificity:
92.30% for Zika IgM
88.10% for Zika IgG
97.50% for Dengue IgM
85.00% for Dengue IgG
94.90% for CHIKV IgM
88.20% for CHIKV IgG

Manufacturer product reference: Chembio Diagnostic, 65-9565-0

Items supplied with:
DPP ZCD IgM/IgG Assay System contains the items to perform 20 tests:
-20 x Individually pouched DPP ZCD IgM/IgG System Test Devices with a desiccant
-20 x Disposable 10µl Sample Loops - BLUE
-20 x Sample Tubes/Vials
-20 x Transfer Pipettes (100µl)
-20 x Sterile Safety Lancets (for fingerstick whole blood specimens)
-20 x Bandages
-1 x DPP ZCD IgM/IgG Buffer - 9.5ml
-1 x Product Insert for the DPP ZCD IgM/IgG Assay System

Inclusive of the required DPP Micro Readers (i.e. 1 x DPP Micro Reader for each 3000 tests)

Items required, but not supplied with:
Clock/watch/timer; pipettor capable of delivering 10-100μL of sample may be used in lieu of the disposable 10μL sample loop or 100μL transfer pipettes supplied with the Kit (for venous whole blood, serum or plasma specimens); disposable gloves; sterile gauze for fingerstick whole blood specimens; antiseptic wipes; biohazard disposal container; collection devices (for venous whole blood or serum/plasma specimens)

Shelf life:
24 months from the date of manufacture.

Weight and volume:
Estimated weight: 0.9 kg
Estimated volume: 0.001 m3

Storage condition:
It should be stored at 2 to 30°C.

Hazardous material:
Buffer contains less than 0.01% sodium azide. DPP® Micro Reader has 3 Lithium-ion, type CR2032 (3 V/230 mAh), coin cell batteries installed.