Product Manual

WARNINGS AND PRECAUTIONS
Warning
H317: May cause an allergic skin reaction.
P
280: Wear protective gloves/protective clothing/eye protection/face
p
rotection.
•
For in-vitro diagnostic use only.
•
Follow your laboratory safety guidelines in the collection, handling, storage
a
nd disposal of patient specimens and all items exposed to patient specimens.
• The Diluent and Controls contain sodium azide which may react with lead or
copper plumbing to form potentially explosive metal azide. For sites permitted to
dispose of material down a sink: large quantities of water must be used to flush
discarded control material down a sink.
• The Capillary Bulb contains dry natural rubber.
•
Do not interchange or mix components from different kit lots.
SPECIMEN COLLECTION AND PREPARATION
Serum, Plasma or Whole Blood Sample
Obtain specimens by acceptable medical technique. Collect whole blood
samples using a tube containing EDTA or heparin as an anticoagulant. Other
anticoagulants have not been tested. Serum and plasma specimens may be
refrigerated (2°-8°C; 36°-46°F) and tested within 48 hours; serum and plasma
specimens held for longer times should be frozen (below -10°C; 14°F) and tested
within 3 months. Test whole blood specimens within 24 hours. Specimens must
be at room temperature (15°-30°C; 59°-86°F) when tested.
Fingertip Whole Blood
Hold the capillary tube horizontally while collecting the sample. Holding the capillary
tube near the red circle, touch the other end of the capillary tube to the drop of
blood on the patient’s finger. Fill the capillary tube completely. Place the small end
of the black bulb onto the capillary tube. Place your fingertip over the opening in the
bulb. Squeeze the bulb to dispense the whole blood sample into the test tube.
QUALITY CONTROL
External Quality Control
For external QC testing, use the controls provided in the kit. Add one free falling drop
of control to the Test Tube and then proceed in the same manner as with a patient
sample. Quality Control requirements should be established in accordance with
local, state and federal regulations or accreditation requirements. Minimally Sekisui
Diagnostics recommends that positive and negative external controls be run with
each new lot and with each new untrained operator. Some commercial controls
may contain interfering additives. The use of these controls is not recommended.
Internal Quality Controls
The OSOM Mono Test provides two levels of internal procedural controls with each
test procedure.
• The red Control Line is an internal positive control. The Test Stick must absorb the
proper amount of sample and be working properly for the red Control Line to appear.
• A clear background is an internal negative control. If the test has been performed
correctly and the Test Stick is working properly, the background will clear to give a
discernible result.
If the red Control Line does not appear, the test is invalid. If the background does not
clear and interferes with the test result, the test may be invalid. Call Sekisui
Diagnostics Technical Assistance if you experience either of these problems.
LIMITATIONS
• As with all diagnostic assays, the results obtained by this test yield data that must
be used as an adjunct to other information available to the physician.
• The OSOM Mono Test is a qualitative test for the detection of IM heterophile antibody.
• A negative result may be obtained from patients at the onset of the disease due to
heterophile antibody levels below the sensitivity of this test kit. If symptoms persist or
intensify, the test should be repeated.
• Some segments of the population with acute IM are heterophile antibody negative
1
.
2