TECHNICAL PROCEDURE IMMUNOSEROLOGY PAGE: 1 of 9

EFFECTIVITY: JUNE 2022

REVISION NO.: 0
RUNNING RAPID QUANTITATIVE SEROLOGICAL TEST USING
FINCARE FIA (FLUORESCENCE IMMUNOASSAY) METER PLUS

1. POLICY

All Medical Technologists conducting analysis of patient’s sample for serological test using
Finecare FIA meter shall run patient’s sample to detect, reduce, and correct deficiencies in
Serology’s analytical process prior to release of patient’s results.

2. PURPOSE

To guide Medical Technologists on how to run patient’s sample and releasing results.

3. EQUIPMENT/REAGENTS/SUPPLIES

3.1 Finecare FIA Meter

3.2 Gloves
3.3 Pipettes( serological pipette/ disposable transfer pipettes)
3.4 Test Cartridge
3.5 Test Cartridge ID Chip
3.6 Detector buffer
3.7 Specimen collection containers (EDTA or RED top)
3.8 Centrifuge
3.9 Pen and marker
3.10 Urine/tube container ( for MAU)

4. SEROLOGICAL TEST

4.1 CRP + hsCRP ( C-Reactive Protein + High Sensitivity C-Reactive Protein)

4.2 CK-MB (MB isoenzyme of Creatine Kinase)
4.3 AFP (Alpha-fetoprotein)
4.4 PCT (Procalcitonin)
4.5 β-HCG (Beta Human Chorionic Gonadotropin)
4.6 PSA (Prostate Specific Antigen)
4.7 D-DIMER
4.8 Micro ALBUMIN

PREPARED BY: REVIEWED BY: APPROVED BY:

YZA LYNNE JOIE L. ABRANTES, RMT OFELIA D. MENDIOLA, RMT EDMUNDO J. VISITACION JR., MD, FPSP, APCP
 TECHNICAL PROCEDURE IMMUNOSEROLOGY
EFFECTIVITY: JUNE 2022

REVISION NO.: 0
RUNNING RAPID QUANTITATIVE SEROLOGICAL TEST USING
FINCARE FIA (FLUORESCENCE IMMUNOASSAY) METER PLUS

PAGE: 2 of 9

5. TECHNICAL PROCEDURE

All Medical Technologists shall wear Personal Protective Equipment (PPE’S) such as
laboratory gown, gloves,
and mask in running quality control.

5.1 STARTING UP THE MACHINE

5.1.1 Place Finecare FIA meter on a dry, clean, flat, horizontal surface. With thw front
surface at least 10vm inside of the table edge.
5.1.2 Plug one end of the adapter into power outlet, plug the opposite end into the
external power interface.
5.1.3 Press the power ON/OFF Switch.
5.1.4 Install Paper. Remove the printer cover by pulling up on the cover.
5.1.5 Tear op or cut a clean, straight paper edge to feed paper roll into the printer.
5.1.6 Position the paper in a way that the paper will feed from under the roll, as
opposed to the over top of the roll.
5.1.7 Insert paper edge under the paper roller until firmly seats or resistance s felt
5.1.8 Place the paper roll into the paper compartment.
5.1.9 Replace the printer cover.
5.1.10 The user can operate the finecare by touching LCD touchscreen by fingertip, or
by mouse or keyboard.
5.1.11 After switching on the meter, wait the meter to boot and show main interface.
The test device tray will protrude automatically.

5.2 RUNNING QUALITY CONTROL

Each Finecare Rapid Quantitative Test Cartridge contains internal control that satisfies routine
quality control requirements.

5.2.1 Navigate to the main interface, click “QC”. The test device tray will protrude. If
the tray does not protrude automatically, click “out”.

PREPARED BY: REVIEWED BY: APPROVED BY:

YZA LYNNE JOIE L. ABRANTES, RMT OFELIA D. MENDIOLA, RMT EDMUNDO J. VISITACION JR., MD, FPSP, APCP
 TECHNICAL PROCEDURE IMMUNOSEROLOGY
EFFECTIVITY: JUNE 2022

REVISION NO.: 0
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5.2.2 Gently insert the quality control card into the test device tray, push the tray inside
the meter until resistance is felt.
5.2.3 Click “Start”
5.2.4 Wait until the blue progress bar runs to the end. The result of Quality Control
PAGE: 3 of 9
will be displayed.
5.2.5 Click “Reset the slot”, to draw back test device tray.
5.2.6 Click “Print” to make printed copy of quality control result if needed.

6. RUNNING TEST

6.1 Insert ID chip into ID chip port until resistance is felt. It is recommended to insert the
ID chip after successful booting. This step is necessary when a new lot of test device of
specific test is applied on the meter for the first time. Once the meter recognizes the Lot
information of the chip, there is no need to read ID chip again before running test,
unless a new lot of test device is applied. The ID chip can either be pulled out once the
lot information is recognized or remain inserted.
6.2 Navigate to the main interface.
6.3 Click “Read ID Chip”. A message said “Warning: The ID chip ready” will prompt,
click “Yes”. It indicates that the ID chip can be recognized by the meter.
6.4 Choose test mode by click on “Quick Test” or “Standard Test”.
6.5 Choose Test mode.
It is assumed that before switching Test Mode, the selector switch for operating mode,
which is on the left side of analyzer, is on MAC. Finecare™ FIA Meter Plus provides two
test modes, the Standard Test mode and Quick Test mode. Standard Test: Push the test
device into the test device tray right after the specimen is fully absorbed. The analyzer
acts as an incubation place for reaction for a preset time duration. Wait until the analyzer
counts down to zero, the test result will be shown on the screen. Quick Test: Push the test
device into the test device tray after the reaction completes.
6.6 Input detailed patient information by clicking “Detailed information”... If the user does
not input a serial number for a record, the analyzer will automatically assign a serial
number for it.
6.7 Apply the test sample on the test device according to instructions of specific test.
6.8 Start the test.

PREPARED BY: REVIEWED BY: APPROVED BY:

YZA LYNNE JOIE L. ABRANTES, RMT OFELIA D. MENDIOLA, RMT EDMUNDO J. VISITACION JR., MD, FPSP, APCP
 TECHNICAL PROCEDURE IMMUNOSEROLOGY
EFFECTIVITY: JUNE 2022

REVISION NO.: 0
RUNNING RAPID QUANTITATIVE SEROLOGICAL TEST USING
FINCARE FIA (FLUORESCENCE IMMUNOASSAY) METER PLUS

Quick Test: Gently push the test device that is completely reacted into the test device
Tray. Click. Click “Start Test”. Standard Test: Gently push the test device into the test
device tray immediately after the specimen is fully absorbed. Click. Click “Start Test”.
6.9 The meter will analyze the test device whilst the blue bar runs.
6.10 After the blue bar stops running, the test result will be shown on the screen. The
test device tray will protrude after the test completes. If not, click “Out”.
6.11 Click “Print” to make a printed copy of the test result; OR If the user ticks the
box “Print automatically”, the test result will be printed automatically every time after
the test result is acquired.
PAGE: 4 of 9

7. TEST INSTRUCTIONS

7.1 CRP + hsCRP

7.1.1 Preparation: Check/insert ID Chip into the equipment.
7.1.2 Sampling: Draw 10 μL of whole blood or 5 μL of serum/plasma with a transfer
pipette and add it to the buffer tube
7.1.3 Mixing: Mix well the specimen with buffer for 1 minute by tapping or inverting
the tube.
7.1.4 Loading: Uncap lip, discard 1 drop and add 3 drops of sample mixture onto the
sample well of the test cartridge and load.
7.1.5 Testing: Click “Start test” (standard test). 3 minutes later, the result will show in
display and print out.
7.1.6 Assay Range and Detection Limit:
7.1.6.1 • Assay Range: 0.5～200 mg/L
7.1.6.2 • Detection Limit : 0.5 mg/L

7.2 CK-MB
7.2.1 Preparation: Before testing, activate “use” in setting then save it. Check/insert ID
Chip into the equipment. Take out one tube of Buffer from refrigerator and
balance it at room temperature for a couple of minutes.
7.2.2 Sampling: Draw 75μL of whole blood, serum/plasma with a transfer pipette and
add it to the buffer tube.
7.2.3 Mixing: Mix well the specimen with buffer for 1 minute by tapping or inverting
the tube.

PREPARED BY: REVIEWED BY: APPROVED BY:

YZA LYNNE JOIE L. ABRANTES, RMT OFELIA D. MENDIOLA, RMT EDMUNDO J. VISITACION JR., MD, FPSP, APCP
 TECHNICAL PROCEDURE IMMUNOSEROLOGY
EFFECTIVITY: JUNE 2022

REVISION NO.: 0
RUNNING RAPID QUANTITATIVE SEROLOGICAL TEST USING
FINCARE FIA (FLUORESCENCE IMMUNOASSAY) METER PLUS

7.2.4 Loading: Take 75μL of sample mixture and load it onto the sample well of the
Test Cartridge.
7.2.5 Testing: Standard test: Insert the Test Cartridge onto the Test Cartridge Holder
and click “Test”. 15 minutes later, choose the sample type, then the result will
show in the display and print out when click “Print”
7.2.6 Assay Range and Detection Limit
7.2.6.1 • Assay Range: 0.30～100ng/mL
7.2.6.2 • Detection Limit : 0.30ng/mL

7.3 PCT
7.3.1 Preparation: Check/insert ID Chip into the equipment.
7.3.2 Sampling: Draw 75μL of whole blood or 50μL of plasma/serum PAGE: with
5 of 9a transfer
pipette and add it to the buffer tube.
7.3.3 Mixing: Mix well the specimen with buffer for 1 minute by tapping or inverting
the tube.
7.3.4 Loading” Take 75μL of sample mixture and load it onto the sample well of the
Test Cartridge.
7.3.5 Testing: Standard test: Insert the Test Cartridge onto the Test Cartridge Holder
and click “Test”. 15 minutes later, the result will show in the display and print
out when click “Print”. Quick test: Put the Test Cartridge on the operation
platform. 15 minutes later, insert the Test Cartridge onto the Test Cartridge
Holder and click “Test”. The result will show in the display and print out when
click “Print”.
7.3.6 Assay Range and Detection Limit
7.3.6.1 • Assay Range: 0.1～100 ng/mL
7.3.6.2 • Detection Limit: 0.1 ng/mL

7.4 PSA
7.4.1 Preparation: Check/insert ID Chip into the equipment. Take out one tube of
Buffer from refrigerator and balance it at room temperature for a couple of
minutes
7.4.2 Sampling: Draw 75μL of serum with a transfer pipette and add it to the buffer
tube.
7.4.3 Mixing: Mix well the specimen with buffer for 1 minute by tapping or inverting
the tube.

PREPARED BY: REVIEWED BY: APPROVED BY:

YZA LYNNE JOIE L. ABRANTES, RMT OFELIA D. MENDIOLA, RMT EDMUNDO J. VISITACION JR., MD, FPSP, APCP
 TECHNICAL PROCEDURE IMMUNOSEROLOGY
EFFECTIVITY: JUNE 2022

REVISION NO.: 0
RUNNING RAPID QUANTITATIVE SEROLOGICAL TEST USING
FINCARE FIA (FLUORESCENCE IMMUNOASSAY) METER PLUS

7.4.4 Loading: Take 75μL of sample mixture and load it onto the sample well of the
Test Cartridge.
7.4.5 Testing: Standard test: Insert the Test Cartridge onto the Test Cartridge Holder
and click “Test”. 15 minutes later, the result will show in the display and print
out when click “Print”. Quick test: Put the Test Cartridge on the operation
platform. 15 minutes later, insert the Test Cartridge onto the Test Cartridge
Holder and click “Test”. The result will show in the display and print out when
click “Print”. Insert the Test Cartridge onto the Test Cartridge Holder. 15
minutes later, the result will show in the display and print out when click “Print”.
7.4.6 Assay Range and Detection Limit
7.4.6.1 • Assay Range: 2~100 ng/ml
7.4.6.2 • Detection Limit: 2ng/mL

7.5 βHCG
7.5.1 Preparation: Before testing, activate “use” in setting then save it. Check/insert ID
Chip onto the equipment. Take out one tube of buffer fromPAGE: 6 of 9
refrigerator and
balance it at room temperature
7.5.2 Sampling: Draw 20μL of whole blood, serum/plasma with a transfer pipette and
add it to the buffer tube.
7.5.3 Mixing: Mix well the specimen with buffer for 1 minute by tapping or inverting
the tube.
7.5.4 Loading: Take 75 μL of sample mixture and load it onto the sample well of the
Test Cartridge.
7.5.5 Testing: Standard test: Insert the Test Cartridge onto the Test Cartridge Holder
and click “Test”. 15 minutes later, choose the sample type, then the result will
show in the display and print out when click “print”.
Quick test: Put the Test Cartridge on the operation platform.15 minutes later,
insert the Test Cartridge onto the Test Cartridge Holder and click “Test”, choose
the sample type, then the result will show in the display and print out when click
“print”. Insert the Test Cartridge onto the Test Cartridge Holder and click “Test”.
15 minutes later, the result will show in the display and print out when click
“print”
7.5.6 Assay Range and Detection Limit
7.5.6.1 • Assay Range: 2-20,0000 mIU/mL
7.5.6.2 • Detection Limit: 2mIU/ml

PREPARED BY: REVIEWED BY: APPROVED BY:

YZA LYNNE JOIE L. ABRANTES, RMT OFELIA D. MENDIOLA, RMT EDMUNDO J. VISITACION JR., MD, FPSP, APCP
 TECHNICAL PROCEDURE IMMUNOSEROLOGY
EFFECTIVITY: JUNE 2022

REVISION NO.: 0
RUNNING RAPID QUANTITATIVE SEROLOGICAL TEST USING
FINCARE FIA (FLUORESCENCE IMMUNOASSAY) METER PLUS

7.6 D-DIMER
7.6.1 Preparation: Check/insert ID Chip into the instrument.
7.6.2 Sampling Draw 15μL of whole blood or 10μL plasma with a transfer pipette and
add it to the buffer tube.
7.6.3 Mixing: Mix well the specimen with buffer for 1minute by tapping or inverting
the tube.
7.6.4 Loading: Take 75μL of sample mixture and load it onto the sample well of the
Test Cartridge.
7.6.5 Testing: Standard test: Insert the Test Cartridge onto the Test Cartridge Holder
and click “Test”. 5 minutes later, the result will show in the display and print out
when click “Print”.
Quick test: Put the Test Cartridge on the operation platform. 5 minutes later,
insert the Test Cartridge onto the Test Cartridge Holder and click “Test”. The
result will show in the display and print out when click “Print”.
7.6.6 Assay Range and Detection Limit
7.6.6.1 • Assay Range: 0.1～10 mg/L
7.6.6.2 • Detection Limit: 0.1 mg/L

PAGE: 7 of 9

7.7 AFP
7.7.1 Preparation: Before testing, activate “use” in setting then save it. Ensure that the
lot number of the Test Cartridge matches ID Chip as well as the Detection
Buffer. Insert ID Chip into FinecareTM FIA System.
7.7.2 Sampling: Draw 75 μL of whole blood or serum or plasma with a transfer pipette
and add into the Detection Buffer tube.
7.7.3 Mixing: Close the lid of Detection Buffer tube and mix the sample mixture
thoroughly by shaking it about 10 times.
7.7.4 Loading: Pipette 75 μL of sample mixture and load it into the sample well of the
Test Cartridge.
7.7.5 Testing: Standard Test mode: Insert the Test Cartridge onto the Test Cartridge
holder of Finecar FIA System right after adding sample mixture to the sample
well. Press “Test” to start testing
Quick Test mode: Set the timer and count down right after adding sample
mixture into the sample well and leave it at room temperature for 15 minutes.
Then insert the Test Cartridge onto the Test Cartridge. Press “Test” to start
testing. Finecare FIA System will start scanning the sample-loaded Test
Cartridge immediately. Results are displayed on main screen or be printed by
press “Print”.

PREPARED BY: REVIEWED BY: APPROVED BY:

YZA LYNNE JOIE L. ABRANTES, RMT OFELIA D. MENDIOLA, RMT EDMUNDO J. VISITACION JR., MD, FPSP, APCP
 TECHNICAL PROCEDURE IMMUNOSEROLOGY
EFFECTIVITY: JUNE 2022

REVISION NO.: 0
RUNNING RAPID QUANTITATIVE SEROLOGICAL TEST USING
FINCARE FIA (FLUORESCENCE IMMUNOASSAY) METER PLUS

7.7.6 Assay Range and Detection Limit

7.7.6.1 ● Assay Range: 5~400 ng/mL
7.7.6.2 ● Detection Limit (Analytical Sensitivity): 5 ng/mL

7.8 MICRO-ALBUMIN
7.8.1 Preparation: Check/insert ID Chip into the equipment.
7.8.2 Loading: Draw 75μL of urine with a transfer pipette and load it to the sample
well of the Test Cartridge.
7.8.3 Testing: Standard test: Insert the Test Cartridge onto the Test Cartridge Holder
and click “Test”. 3 minutes later, the result will show in the display and print out
when click “Print”.
Quick test: Put the Test Cartridge on the operation platform. 3 minutes later,
insert the Test Cartridge onto the Test Cartridge Holder and click “Test”. The
result will show in the display and print out when click “Print”. 2. Finecare™
multi-channel FIA meter: Insert the Test Cartridge onto the Test Cartridge
Holder. 3 minutes later, the result will show in the display and print out when
click “Print”.
7.8.4 Assay Range and Detection Limit
PAGE: 8 of 9
7.8.4.1 • Assay Range: 5~300 mg/L
7.8.4.2 • Detection Limit: 5 mg/L

8. RELEASING OF REULTS

8.1 Staple print out or record results

8.2 Encode or transfer data onto result templates
8.3 Double check result print out before releasing.
8.4 Record data, info and results to corresponding logbook
8.5 Endorse printed results to Lab aide for releasing and endorsement.

9. WARNING, PRECAUTIONS AND LIMITATIONS

9.1 The Finecare™ FIA Meter Plus must be used within the operating environment as
specified in Section Ⅲ.
9.2 Operate the meter on a level, dry surface away from direct sunlight.

PREPARED BY: REVIEWED BY: APPROVED BY:

YZA LYNNE JOIE L. ABRANTES, RMT OFELIA D. MENDIOLA, RMT EDMUNDO J. VISITACION JR., MD, FPSP, APCP
 TECHNICAL PROCEDURE IMMUNOSEROLOGY
EFFECTIVITY: JUNE 2022

REVISION NO.: 0
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9.3 Use only the Power Adapter (including the power cord) provided with Finecare™ FIA
Meter Plus.
9.4 The Quality Control card must be stored away sunlight and moisture when not in use.
9.5 Do not write or place a label anywhere on the Quality control card, as it may interfere
the meter functionally.
9.6 Do not move the meter while a test is in process.
9.7 Ensure the sample fluids are fully absorbed before the test device is inserted in the
meter in order to prevent internal contamination of the meter.
9.8 The test device tray shall be kept inside the main body of the meter all the time unless
the user intends to put a test device or quality control card in it.
9.9 The used Test device should be treated as potentially bio-hazard and should be disposed
of according to the standard procedures and relevant regulations.
9.10 Gloves, goggles or other protective measures should be used when handling
potential infectious materials.
9.11 Do not insert anything other than a test device provided by the manufacturer into
the test device Tray.
9.12 Do not spill any liquid on Finecare™ FIA Meter Plus. Don’t immerse the meter
into water or other liquids.
9.13 Do not drop or crash Finecare™ FIA Meter Plus.
9.14 Do not dismantle Finecare™ FIA Meter Plus without written authorization from
Guangzhou Wondfo Biotech Co., Ltd. or its representative.
9.15 Do not place objects on Finecare™ FIA Meter Plus. This may damage the
optical alignment in turn result in compromised performance or mechanical damage.
9.16 The mains outlet for Finecare™ FIA Meter Plus shall be located in a user
accessible position for easy unplugging in emergency. PAGE: 9 of 9

10. MAINTENANCE AND CARE

10.1 Maintenance: Besides regular cleaning or replacing print paper roll when
needed, Finecare™ FIA Meter Plus needs minimal maintenance. The instrument shall
be plugged out prior to cleaning.
10.2 Cleaning: Use a damp cloth with 0.5% bleach, 70% isopropyl alcohol or 70%
ethanol to clean the external surface of the instrument. Strong bleach (bleach
concentration over 0.5%), oxidizing substances or solvents can cause permanent
damage to the screen and other external surface material thus are prohibited to be
applied to the meter. If the meter has been used in clinical setting and needs to be
repackaged, replaced or transported, it must be cleaned. Use disinfectant (e.g. bleach
concentration lower than 0.1%) and a cloth to wipe external surface of the instrument

PREPARED BY: REVIEWED BY: APPROVED BY:

YZA LYNNE JOIE L. ABRANTES, RMT OFELIA D. MENDIOLA, RMT EDMUNDO J. VISITACION JR., MD, FPSP, APCP
 TECHNICAL PROCEDURE IMMUNOSEROLOGY
EFFECTIVITY: JUNE 2022

REVISION NO.: 0
RUNNING RAPID QUANTITATIVE SEROLOGICAL TEST USING
FINCARE FIA (FLUORESCENCE IMMUNOASSAY) METER PLUS

thoroughly. Spray-washing or clean any internal parts and inner surface with
disinfectant are prohibited as liquid may seep inside the meter

11. REFERENCES

11.1 Finecare FIA Meter Plus Operation Manual Model No. FS-114
Guanzhou Wondfo Biotech Co., Ltd
11.2 Finecare Rapid Quantitative Test Inserts

PREPARED BY: REVIEWED BY: APPROVED BY:

YZA LYNNE JOIE L. ABRANTES, RMT OFELIA D. MENDIOLA, RMT EDMUNDO J. VISITACION JR., MD, FPSP, APCP