COVID-19 ANTIGEN RAPID TEST DEVICE

タイトルまたは説明

PERFORMANCE CHARACTERISTICS
OVID**9 Ag Rapid Test  PCR
                                    Positive  Negative  TOTAL
Positive                        *8             3              *1
Negative                       0             **3          **3
TOTAL                          *8            **6          **4
Relative Sensitivity: *8/*1 *6.*9% (*5%CI: *2.*8%~**0%)
Relative Specificity: **3/**3 **0% (*5%CI: **0%~**0%)
Overall Agreement: **1/**4 *8.*3% (*5%CI: *6.*8%~**0%)


Bring tests, specimens, and/or controls to room temperature
(****0°C) before use.
1.  Remove the test from its sealed pouch, and place it on a clean,
level surface. Label the device with patient or control identification. For
best results, the assay should be performed within one hour.
2.  Gently mix Extraction reagent solution. Add 6 drops(about **0ul)
of the Extraction Solution into the Extraction tube.
3.  Place the patient swab specimen into the Extraction Tube. Roll
the swab at least *0 times while pressing the swab against the bottom
and side of the Extraction Tube. Roll the swab head against the inside of
the Extraction Tube as you remove it. Try to release as much liquid as
possible. Dispose of the used swab in accordance with your biohazard
waste disposal protocol.
4.  Put on the tube tip, then add 4 drops of extracted sample into the
sample well. Do not handle or move the Test Device until the test is
complete and ready for reading.
5.  As the test begins to work, color will migrate across the
membrane. Wait for the colored band(s) to appear. The result should be
read at *0 minutes. Do not interpret the result after *0 minutes.