Test
Cells
8.5ml 2x8.5 ml 2x33 ml
T. Pallidum antigen coated preserved fowl erythrocytes (approx 0.36% w/v) in buffer. Working Strength.
Control
Cells
8.5ml 2x8.5ml 2x33 ml
Preserved fowl erythrocytes (approx 0.36% w/v) in buffer. Working Strength.
DIL
20ml 2x20ml 3x57ml
Diluent. Selected rabbit serum (approximately 0.4%) in buffer. Working Strength.
Control
+
1ml
1ml
9ml
Positive Control. Serum prediluted (1/20) in buffer containing antibodies to T. pallidum. Working Strength.
Control
–
1ml
1ml
9ml
Negative Control. Serum prediluted (1/20) in buffer free of antibodies to T. pallidum. Working Strength.
CELL DROPPERS
2
2
0
INSTRUCTION LEAFLET
1
1
1
MATERIALS REQUIRED BUT NOT PROVIDED
Dynex M24A U-well microtitration plates are recommended. Microtitration droppers to deliver 25l or Micropipettes to deliver 10, 25, 75, 100l and 190l volumes.
Note: 75l droppers do not fit and are not supplied for bottles in the 850 Test Kit.
PRECAUTIONS
IMMUTREP TPHA reagents contain material of human origin and have been tested and confirmed negative for HCV, HIV I and HIV II antibodies, and HBsAg by approved procedures at single donor level. Because no test can offer complete assurance that products derived from human source will not transmit infectious agents it is recommended that the reagents within this kit be handled with due care and attention during use and disposal. All reagents should, however, be treated as potential biohazards in use and for disposal. Do not ingest.
IMMUTREP TPHA reagents do not contain dangerous substances as defined by current UK Chemicals (Hazardous Information and Packaging for Supply) regulations. All reagents should, however, be treated as potential biohazards in use and disposal. Final disposal must be in accordance with local legislation.
IMMUTREP TPHA reagents contain 0.095% sodium azide as a preservative which may be toxic if ingested. Sodium azide may react with lead and copper plumbing to form highly explosive salts. On disposal, flush with large quantities of water.
STORAGE
Reagents must be stored upright at temperatures between 2oC to 8oC.
The kit will perform within specification until the stated expiry date as determined from date of product manufacture and stated on kit and components. Expiry date is the last day of the month on the bottle and the kit label. Do not use reagents after the expiry date.
Exposure of reagents to excessive temperatures should be avoided. Do not expose to direct sunlight.
DO NOT FREEZE ANY OF THE REAGENTS as this will cause irreversible damage.
SPECIMEN COLLECTION AND PREPARATION
Obtain a sample of venous blood from the patient and allow a clot to form and retract. Centrifuge clotted blood sample and collect clear serum. Fresh serum samples are required.
Obtain a sample of CSF from the patient.
Do not use haemolysed, contaminated or lipaemic samples for testing as this will adversely affect the results.
Samples may be stored at 2oC to 8oC for up to 48 hours prior to testing. If longer storage is required, store at –20oC for up to 1 year. Thawed samples must be mixed prior to testing.
Do not repeatedly freeze-thaw the specimens as this will cause false results.
REAGENT PREPARATION
All reagents should be brought to room temperature (20oC to 25oC) and fully resuspended prior to use. Do not induce foaming.
The Cell Droppers are provided for use with the Test and Control Cell suspensions. These droppers dispense 75l drops and these integral droppers should be placed on their corresponding suspensions as follows:
Red Dropper – Test Cells
White Dropper – Control Cells
850