STANDARD Q HIV/Syphilis ComboTest,kit/25

General Description:
STANDARD Q HIV/Syphilis Combo Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies specific to HIV-1 including subtype O, HIV 2 and Syphilis (Treponema pallidum) in human serum, plasma or whole blood. The test is for in vitro diagnostic use and intended as an aid to early diagnosis of HIV and Syphilis infection for HIV or Syphilis infected patients, patients with signs and symptoms (HIV and Syphilis) and persons at risk. The test is able to quick screen the HIV/syphilis infection and gives the advantage of managing these two diseases at the same time.

Technical specifications:
Technology: Rapid chromatographic immunoassay.
Format: Test cassette, 25 tests.
Sample type: serum/plasma/venous whole blood specimen
Sample volume: Serum Plasma 10µl/whole Blood 20 µl.
Sensitivity: HIV 100% & Syphilis 98.8%
Specificity: HIV 99.9%/syphilis 100%/
Time to result: Minimum of 15 minutes.

Manufacturer product reference: SD Biosensor, 09HIV20D

Kit content:
·1x25The test device (individually in a foil pouch with desiccant).
·1x1 Buffer Bottle, 4 ml.
·1x25 sterile lancet.
·1xpack of 25 Capillary tube (20μl).
·1x 25 Alcohol swab.
·1x IFU.

Items required, but not supplied:
General Lab equipment’s:
·Micropipette and tip.
·Blood collection tube.
·PPE (Personal Protective Equipment).
·Biohazard container.
·Timing device.

Shelf life:
·24 months.

Storage and transportation:
Store the kit unopened at 2 to 40°C, out of direct sunlight.

Packaging and labeling:
Primary packaging: All contents of STANDARD Q HIV/Syphilis Combo Test for 25 tests.

Secondary packaging: One kit STANDARD Q HIV/Syphilis Combo Test Kit/25T.

Weight and volume:
Estimated weight: 0.245 Kg.
Estimated volume: 1.45 dm3

General recommendations:
1.Carefully read the instruction for using the STANDARD Q HIV/Syphilis Combo Test.
2.Check the expiry date at the back of the foil pouch. Use another lot, if expiry date has passed.
Open the foil pouch and check the test device and the colour indicator desiccant pack in foil pouch

Useful links:
WHO list of prequalified in vitro diagnostic products: