careHPV Test, kit/96

General description:
The careHPV Test technology is an in vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of 14 high-risk types of HPV DNA in cervical specimens. This test is “For Professional Use Only” by trained and validated laboratory personnel. The instructions for use must be read carefully before using the test. The careHPV Test is not intended for use in screening women under the age of 30 or women who are pregnant.

Technical Specification:
Positive percent agreement %
·Initial (95% CI) - 70.93% (60.14-80.22)
·Final (95% CI) - 74.42% (63.87-83.22)
Negative percent agreement %
·Initial (95% CI) - 96.68% (94.40-98.22)
·Final (95% CI) - 97.45% (95.36-98.77)
Invalid rate: 0%
Validated specimen types: Cervical specimens collected in careHPV Collection Medium(CCM) using the careHPV Cervical Brush (careBrush).
Time to result: Approximately 3h30min

Kit content:
·1 x Assay microplate (96-well)
·1 x Negative Calibrator (0.5 ml)
·1 x Positive Calibrator (0.5 ml)
·1 x Reagent 1 (3 ml)
·1 x Indicator Dye (0.35 ml)
·1 x Reagent 2
·1 x Reagent 3
·1 x Reagent 4
·1 x Reagent 6
·1 x Reagent 2 diluent (4.5 ml)
·1 x Reagent 3 diluent (3 ml)
·1 x Reagent 4 diluent (5 ml)
·1 x Reagent 6 diluent (5 ml)
·1 x Reagent 5 (250 ml)
·1 x Reagent 5 nozzle
·1 x Assay Data Recording Sheet
·1 x Handbook

Manufacture product reference:
614015 (QIAGEN GmBH)

Items required but not provided:

Consumables:
Specimen collection material: careHPV Collection Medium (CCM) and careBrushes
Foam specimen tube rack
Fixed volume pipette
Repeat pipette
Repeat-pipette tips appropriate for dispensing 20 µl, 25 µl, and 40 µl
Plate sealers
Powder-free gloves
Paper towels
Bleach
70% Isopropyl alcohol
Personal protection equipment

Equipment:
careHPV Test System (cat. no. 9001772), including:
careHPV Test Controller (9001775)
careHPV Test Luminometer (9001773)
careHPV Test Shaker (9001774)
careHPV Test Magnetic Plate Holder (9019960)


Weight and Volume:
Estimated weight: 0.8 kg
Estimated volume: 10.00 dm3

Shelf life:
12 Months

Transport and storage conditions: 4–25 deg. C

Material safety data sheet information (MSDS):
Can be found at https://www.qiagen.com/fi/



Useful Link:

WHO PQ Report: