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:
Sample type: Serum, plasma, whole blood
Sample volume: Serum, Plasma - 10µl and whole Blood - 20µl
Sensitivity: HIV 100% and Syphilis 95.5%
Specificity: HIV 99.5% and Syphilis 99.5%
Time to result: 15-20 mins

Manufacturer product reference:
SD Biosensor, Korea. 09HIV20D

QMS/Regulatory information:
·ROW (Rest-of-World)
·ISO 13845:2016
·WHO Pre-Qualified product

Items supplied with:
·25 x Test device pouch containing: 1 test device, 1 desiccant
·1 x Buffer bottle (4.0ml)
·25 x Capillary tubes (20ul) (Manufacturer: HLB LIFE SCIENCE CO., LTD., Korea)
·25 x Sterile non-safety lancets (Manufacturer: Beijing Ruicheng Medical Supplies Co., Ltd. China - CE Marked)
·25 x Alcohol swab (Manufacturer: HLB Co., LTD. Healthcare. Korea)
·1 x IFU

Items required, but not supplied:
Micropipette and tip, blood collection tube, PPE (Personal Protective Equipment), biohazard container, timing device

Shelf life:
24 months from the date of manufacturing; do not use beyond its expiry date.

Weight and volume:
Estimated weight: 0.22kg
Estimated volume: 0.002dm3

Storage and transportation condition:
The test kit should be stored at 2 - 40°C, protect against humidity and direct sunlight. Do not freeze reagents.

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, 25 tests

General recommendations:
https://extranet.who.int/prequal/sites/default/files/whopr_files/PQDx_03 82-117-00_Standard_Q-HIV-SyphilisComboTest.pdf

Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).