DPP ZIKV IgM/IgG System/PACK-20

General description:
The Chembio DPP Zika IgM/IgG System is a single-use rapid immunochromatographic test for the detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to Zika virus in fingerstick whole blood, EDTA venous whole blood, serum, or EDTA plasma samples. The Chembio DPP Zika IgM/IgG System is intended for use in clinical and point-of-care (POC) settings to aid in the diagnosis of infection with Zika virus (ZIKV) only in patients with clinical symptoms consistent with Zika; a recent history of travel to geographic regions during a period of active Zika virus transmission at the time of travel; and/or other epidemiologic criteria for which Zika virus testing may be indicated as part of public health response. This test is intended to provide a preliminary result. Results of this test cannot be used as the sole basis of patient management decisions and must be combined with clinical observations, patient history, epidemiological information, and another laboratory evidence. Results must be confirmed following the recommended national testing algorithm for ZIKA disease.

It is only for surveillance purpose, not for diagnostic purpose.

Technical specifications:
The Chembio DPP Zika IgM/IgG System includes the DPP Zika Test Device and the 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 (T) and CONTROL (C) areas in each readout window of the test cassette. The top reagent strip (T1) is for the detection of ZIKV IgM antibodies and the bottom reagent strip (T2) is for the detection of ZIKV IgG antibodies.
Sample type: Whole blood, venous blood, serum, plasma
Time to results: Read the results with the use of Micro Reader between 10-15mins after adding buffer.
Specificity: 85.80% for IgM
59.60% for IgG
Sensitivity: 81.40% for IgM
92.70% for IgG

Manufacturer product reference: Chembio Diagnostic, 65-9553-0

Items supplied with:
DPP Zika IgM/IgG System kit contains the items to perform 20 tests:
·20 x Individually pouched DPP Zika IgM/IgG System Test Devices with a desiccant
·20 x Disposable 10µl sample loops
·20 x Sample vials/tubes
·20 x Transfer pipettes (100µl)
·1 x DPP IgM/IgG Buffer (9ml)
·1 x IFU
·DPP Zika IgM/IgG Micro Reader (Product reference code:70-1049-0)

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; sterile safety lancets for fingerstick whole blood specimens; collection devices (for venous whole blood or serum/plasma specimens)

Shelf life:
24 months from the date of manufacturing.

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

Storage condition:
It should be stored at 2 to 30°C. Do not freeze.

Packaging & labelling:
Primary packaging: All contents of DPP ZIKV IgM/IgG System, kit for 20 tests
Secondary packaging: One kit DPP ZIKV IgM/IgG System, 20 tests

General recommendations:
·The test kit is single use only.
·Read the Product Insert completely before using this assay.
·Use of this test kit with sample types other than those specifically approved for use with this device may result in inaccurate test results.
·Do not use any test device if the pouch has been perforated.
·This test should be performed at 18 to 30°C. If stored refrigerated, ensure that the pouch and buffers are brought to operating temperature before performing testing.
·Dispose of all samples and materials used in the test procedure in a biohazard waste container. Lancets should be placed in a puncture-resistant container prior to disposal. Proper handling and disposal methods should be established according to local regulations.