Standard Q Arbo - Panel I/pack 10

General description:
The SD Biosensor STANDARD Q Arbo Panel I (Z/D/C/Y) Test is a rapid chromatographic immunoassay for the detection of Zika IgM, Chikungunya IgM, Dengue IgM, Yellow fever IgM and Dengue NS1 antigen in human serum, plasma or whole blood. The SD Biosensor (SDB) STANDARD Q Arbo Panel Test 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 by following the recommended national testing algorithm for ZIKA disease.

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

Technical specifications:
This test utilizes the principle of immunochromatographic assay. STANDARD™ Q Arbo Panel I (Z/D/C/Y) Test has five devices, the one device for the Zika IgM, the second device for CHIKV IgM, the third device is Dengue IgM, the fourth device for YFV IgM and the fifth device for dengue NS1 antigen.
Sample type: Whole blood, venous blood, serum, plasma
Sample Volume: 10µl (IgM), 100µl (NS1 Ag)
Time to results: 15 minutes
Sensitivity:
96.8% for Zika IgM
71.8% for Dengue IgM
90% for Dengue NS1
86.3% for CHIKV IgM
84.6% for YFV IgM
Specificity:
90.8% for Zika IgM
80.7% for Dengue IgM
90.2% for Dengue NS1
98.6% for CHIKV IgM
92% for YFV IgM

Manufacturer product reference: SD Biosensor Inc
Reference Number: QZKA06D
Product Code: 09ZK110U

Items supplied with:
STANDARD Q Arbo Panel I (Z/D/C/Y) Test kit contains the items to perform 10 tests:
·10 x Individually packed pouches, each contains a STANDARD Q Arbo Panel I (Z/D/C/Y) Test device and silica gel
·10 x Sample collector - Disposable dropper (100µl)
·40 x Sample collector - STANDARD™ Ezi tube+ (10ul)
·10 x Safety lancet
·10 x Alcohol swab
·1 x Assay diluent 1 (4ml, Zika, CHIKV, Dengue IgM)
·1x Assay diluent 2 (4ml, YFV IgM)
·1 x IFU

Items required, but not supplied with:
Clock/watch/timer; disposable gloves; sterile gauze for fingerstick whole blood specimens; biohazard disposal container; collection devices (for venous whole blood or serum/plasma specimens)

Shelf life:
24 months from the date of manufacturing.

Weight and volume:
Estimated weight: 0.536kg
Estimated volume: 0.003m3

Storage condition:
It should be stored at 2 to 40°C. Do not freeze.

Packaging & labelling:
Primary packaging: All contents of Standard Q Arbo - Panel I, kit for 10 tests
Secondary packaging: One kit Standard Q Arbo - Panel I, kit for 10 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.
·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.