LABORATORY TEST PROCEDURES

HEMATOLOGY

Complete Blood Count

1. Click "Menu".
2. Put the microcentrifuge tube into the slot.
3. Click "Diluent".
4. Click Aspirate".
5. Transfer 20 uL of blood sample into the microcentrifuge tube.
6. Close the microcentrifuge tube, and invert it 15-20 times.
7. Open the microcentrifuge tube and put it back into the machine.
8. Click "Enter".
9. Click "Aspirate".
10. Choose "Enter"
11. Record the result of the following:
 Hematocrit;
 Hemoglobin;
 Red Blood Cell count;
 White Blood Cell count;
 Segmenters; and
 Lymphocytes

Platelet Count
1. Click "Menu".
2. Put the microcentrifuge tube into the slot.
3. Click "Diluent".
4. Click Aspirate".
5. Transfer 20 uL of blood sample into the microcentrifuge tube.
6. Close the microcentrifuge tube, and invert it 15-20 times.
7. Open the microcentrifuge tube and put it back into the machine.
8. Click "Enter".
9. Click "Aspirate".
10. Choose "Enter".
11. Record the result of the Platelet Count.

Hematocrit
1. Click "Menu".
2. Put the microcentrifuge tube into the slot.
3. Click "Diluent".
4. Click Aspirate".
5. Transfer 20 uL of blood sample into the microcentrifuge tube.
6. Close the microcentrifuge tube, and invert it 15-20 times.
7. Open the microcentrifuge tube and put it back into the machine.
 8. Click "Enter".
9. Click "Aspirate".
10. Choose "Enter"
11. Record the result of the Hematocrit level.

Hemoglobin
1. Click "Menu".
2. Put the microcentrifuge tube into the slot.
3. Click "Diluent".
4. Click Aspirate".
5. Transfer 20 uL of blood sample into the microcentrifuge tube.
6. Close the microcentrifuge tube, and invert it 15-20 times.
7. Open the microcentrifuge tube and put it back into the machine.
8. Click "Enter".
9. Click "Aspirate".
10. Choose "Enter":
11. Record the result of the Hemoglobin.

PTPA TEST PROCEDURE

1. Power on the instrument.

2. Remove a test strip from its foil pouch. Insert it into the instrument as instructed on the
display screen.
3. The instrument will warm the test strip to the required temperature. Wait till the
preheating is done and the instrument reminds of adding sample.
4. Load 20 ul of specimen into the sample well. Vigorous agitation and foaming should be
avoided.
5. Results are displayed on the main screen. Test results can be printed if the instrument is
connected to a printer.
6. Remove the used test strip from the instrument. Discard it with used pipette tip or
capillary tube according to local regulations and procedures.

APTT TEST PROCEDURE

1. Power on the instrument.
2. Remove a test strip from its foil pouch. Insert it into the instrument as instructed on the
display screen.
3. The instrument will warm the test strip to the required temperature. Wait until the
preheating is done and the instrument reminds of adding sample.
4. Load 20 uL of blood specimen into the sample well. Vigorous agitation and foaming
should be avoided.
5. Results are displayed on the main screen. Test results can be printed if the instrument is
connected to a printer.
 6. Remove the used test strip from the instrument. Discard it with used pipette tip or
capillary tube according to local regulations and procedures.

BLOOD CHEMISTRY

Sodium
Manual
1. Use Electrolyte Analyzer or Manual Method
2. Use water blank as your “blank”
3. Dispense 1500 uL of reagent on two tubes (label as standard and patient).
4. Add 50 uL of standard and sample on respective tubes.
5. Add 50 uL color developer
6. Incubate for 1 minute at room temperature (25-30°C)
7. Read at 540nm.
8. Calculate:
Absorbance of Unknown
-------------------------------------×140
Absorbance of standard

Automated (Mindray)

1. Click Program
2. Type the name of the Patient in the "BARCODE".
3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

Potassium
Manual
1. Dispense 1500uL of reagent in two tubes (label as standard and patient).
2. Add 50uL of standard and sample on respective tubes. Use water as blank.
3. Add 50uL of color developer.
4. Incubate for 1 minute at room temperature.
5. Read at 600nm.
6. Record the result. Compute the value of potassium by dividing the absorbance of
unknown by absorbance of standard, then multiply it to 4.5

Automated (Mindray)

1. Click Program
2. Type the name of the Patient in the "BARCODE".
 3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

Chloride
Manual
1. Dispense 1500 ul of Reagent on two tubes (label as standard and patient)
2. Add 50 uL of standard and sample on respective tubes

3. Incubate for 1 minute @room Temperature (25- 30°C)

4. Read at 492 nm
5. Calculate:
Absorbance of Unknown
-------------------------------------×100
Absorbance of standard

Automated (Mindray)

1. Click Program
2. Type the name of the Patient in the "BARCODE".
3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

SGOT/AST
Manual
1. Dispense 800 uL of Reagent of Reagent 1 + 200 uL of Reagent 2 on two tubes(Label as
Blank and patient)
2. Add 100 uL of distilled water and sample on respective tubes
3. Incubate for 3 minutes @ 37°C
4. Exactly read the absorbance for every 1 minute. Get the average.
5. Read at wavelength 340 nm
6. Calculate:
Absorbance average per minute x 0.1745

Automated (Mindray)

1. Click Program
 2. Type the name of the Patient in the "BARCODE".
3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

SGPT/ALT
Manual
1. Dispense 800 uL of Reagent of Reagent 1 + 200 ul of Reagent 2 on two tubes(Label as
Blank and patient)
2. Add 100 uL of distilled water and sample on respective tubes
3. Incubate for 3 minutes at 37°C
4. Exactly read the absorbance for every 1 minute. Get the average.
5. Read at wavelength 340 nm
6. Calculate:
Absorbance average per minute x 0.1745

Automated (Mindray)

1. Click Program
2. Type the name of the Patient in the "BARCODE".
3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

Total Cholesterol
Manual
1. Dispense 1250 uL (1.25mL) of reagent on three tubes (label test tube as Blank, Standard,
Patient)
2. Add 10 uL of distilled water,Standard and sample on repective tubes.
3. Add 50 uL of Color Enzyme on each tubes.
4. Incubate for 10 minutes at 37°C
5. Read at wavelength 510 nm
6. Calculate: Absorbance of Unknown X 200 X 0.026/Absorbance of standard

Automated (Mindray)

1. Click Program
2. Type the name of the Patient in the "BARCODE".
 3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

Triglyceride
Manual
1. Dispense 1000 uL (1mL) of reagent on three tubes (label test tube as Blank, Standard,
Patient).
2. Add 10 uL of distilled water, Standard and sample on repective tubes.
3. Incubate for 5 minutes at 37°C.
4. Read at wavelength 520 nm.
5. Calculate:
Absorbance of Unknown
-------------------------------------×200
Absorbance of standard

Automated (Mindray)

1. Click Program
2. Type the name of the Patient in the "BARCODE".
3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

HDL Cholesterol
Manual
1. Dispense 0.2 mL specimen into tubes labeled control sample 1, etc.
2. Add 0.2 mL HDL Cholesterol reagent.
3. Mix well and allow to stand at ambient temperature for 10 minutes.
4. Centrifuge at 1000xg (3/4 speed) for 10 minutes.

Automated (Mindray)

1. Click Program
2. Type the name of the Patient in the "BARCODE".
3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
 5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

LDL Cholesterol
Manual
1. Calculate:
Cholesterol – Triglycerides/5 – HDL = LDL (mg/dL)

Automated (Mindray)

1. Click Program
2. Type the name of the Patient in the "BARCODE".
3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

Glucose
Glucometer
1. Use Glucometer
2. Result in Glucometer multiply to 0.055 mg/dL.

Automated (Mindray)

1. Click Program
2. Type the name of the Patient in the "BARCODE".
3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

Creatinine
Manual
1. Dispense 750 uL Picric Acid + 750 ul Base reagent on three tubes (label test tube as
Blank, Standard, Patient)
2. Add 50 uL of distilled water, standard and sample on repective tubes.
3. Incubate for 15 minutes at 37°C
4. Read at wavelength 510 nm
 5. Compute:
Absorbance of Unknown x 6 x 88.4 mmol/L/Absorbance of standard

Automated (Mindray)

1. Click Program
2. Type the name of the Patient in the "BARCODE".
3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

Blood Uric Acid (BUA)

Manual
1. Dispense 1250 uL (1.25mL) of reagent on three tubes (label test tube as Blank, Standard,
2. Patient).
3. Add 25 uL of distilled water,standard and sample on respective tubes.
4. Add 50 uL of Color Enzyme on each tubes.
5. Incubate for 10 minutes at room temperature.
6. Read at wavelength 520 nm.
7. Calculate:
Absorbance of Unknown/Absorbance of standard x 10

Automated (Mindray)

1. Click Program
2. Type the name of the Patient in the "BARCODE".
3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

Blood Urea Nitrogen (BUN)

Manual
1. Dispense 500 uL (0.5mL) of UREA N COLOR reagent + 500 uL UREA NZYME
REAGENT on three tubes (label test tube as Blank, Standard, Patient)
2. Add 10 uL of distilled water,standard and sample on respective tubes. Incubate for 5
minutes at 37°C.
3. Add 2000 uL (2 mL) of UREA N BASE REAGENT on each tubes.
4. Incubate for 5 minutes at 37C.
 5. Read at wavelength 640 nm.
6. Calculate:
Absorbance of Unknown/ Absorbance of standard x 25 mg/dL

Automated (Mindray)

1. Click Program
2. Type the name of the Patient in the "BARCODE".
3. Place the sample in the machine according to the sample position in the computer (Make
sure the sample is clear and not LIPEMIC)
4. Click the test(s) requested (example Glu-G, Crea-S, etc.)
5. Click "SAVE" or F8. (Don't forget to click The "SAVE" button)
6. Click the Play button
7. To check result --> Click "Result" then Find the Name of the Patient

HbA1c (LabonaCheck)

Test procedure
 Important procedural notes
 Do not interchange components from different kit lots.
 It shall be equilibrated to room temperature before using the R1/Reagent,
R2/Reagent, and cartridge.
 Do not touch the membrane with the pipette tip
 Change the pipette tip between each pipetting step.

 Sample material
 Capillary blood and venous blood with or without anticoagulants (EDTA, heparin
and NaF) can be used.

1. Add 5 ul whole blood to the test tube pre-filled with the R1/Reagent. Mix well. Leave the
tube for minimum 2 minutes, maximum 3 minutes. Do not leave it more than 3 minutes.
NOTE: Make sure that the R1/Reagent shall be equilibrated to room temperature before
using.
2. Once the reaction mixture is completed, shake the test tube once again for the
components to be blended well. Open the tube and collect 25 ul. Apply that 25 ul to the
cartridge. Leave it for 10 seconds so as the applied sample to soak enough into the
membrane.
NOTE: Do not touch the membrane with the pipette tip.
NOTE: Avoid bubbling during applying the mixture on the membrane filter of the
cartridge.
3. When the sample is absorbed completely, apply 25 ul of the R2/Reagent to the cartridge.
Allow the sample to soak into the membrane for about 10 seconds.
NOTE: Avoid bubbling during applying the R2/Reagent on the membrane filter of the
cartridge.
 4. Once the sample is absorbed completely, place the cartridge on the tray and then select
"Analyze" on the display. The tray shall be inserted into the LabonaCheck™ A1c HbA1c
Analyzer.
NOTE: Review the User Manual of the LabonaCheck™ A1c HbA1c Analyzer for
operation.

Hemoglobin A1c

1. Select Program
2. Select Sample and select Hb-2 or HbA1c-2.
3. Input the programming information and click Save F8.
4. Place the sample in the defined positions on the sample carousel or sample rack or place
the bar coded samples in any position on the sample carousel or sample rack.
5. Click Start button, set the test conditions and start the test.
6. The results of the on-board pretreatment tests on the Result screen are displayed with
purple.

Manual pretreatment test mode

1. Prepare hemolysate
Centrifuge the whole blood sample to get 25 μL red blood cell from the blood corpuscle
deposition and add it to 500 μL pretreatment reagent, mix them and place the mixture for
5 minutes, and then run its test on the analyzer.
Note: This step is not required for QC sample or hemolysis sample.

2. Test procedure
Select Program->Sample and select Hb-2 or HbA1c-2. Select Options F2 to deselect
Pretreatment for Hb-2 or HbA1c-2 and click OK. Select Save F8. Then place the sample
in the defined positions on the sample carousel or sample rack
Click Start button, set the test conditions and start the test.

SEROLOGY AND BLOOD BANKING

Dengue Duo Test (Abbott; Bioline)

Test Procedure 
1. Allow all kit components and specimens to reach room temperature (between 15 °C and
30°C) prior to opening and testing.
2. Remove the test device from the foil pouch, and place it on a flat dry surface. Label the
test device with a patient identifier. Perform the test immediately to avoid exposing the
test device to moisture.
[Dengue NS1 Ag]
1. With a disposable dropper provided, dispense 3 drops (about 100 µl) of specimen into the
specimen well "S"

[Dengue IgG/IgM]
2. With 10 µl capillary pipette provided, draw specimen to fill line (10 µl) then dispense into the
square specimen well.
3. Dispense 4 drops (about 90-120 µl) of assay diluent into the round assay diluent well. 

[Dengue NS1 and Dengue IgG/IgM]

4. Interpret test results at 15-20 minutes. 
Caution: Do not read test results after 20 minutes; reading after 20 minutes can yield false
results.

TEST INTERPRETATION
 
Caution: The appearance of any Test Line, no matter how faint, must be interpreted as positive.
For optimal diagnostic efficiency, an individual should be considered positive for dengue
infection if any one of the three Test Lines (NS1, IgG or IgM) appears.

[Dengue NS1 Ag]

 Negative result: The presence of only Control Line ("C") in the result window indicates
that NS1 antigen was not present in the specimen or is present below the detectable
levels.
 Positive result: The presence of two colored lines ("C" and "T") in the result window
indicates that the specimen is positive for NS1 antigen. This suggests an early dengue
infection. 
 Invalid result: No Control Line ("C") in the result window means the test is Invalid,
whether or not the Test Line ("T") is present. The instructions may not have been
followed correctly or the test may have been compromised. When an Invalid result is
obtained, it is recommended that the specimen be retested using a new device. 

[Dengue IgG/IgM]
 Negative result: The presence of only Control Line ("C") in the result window indicates
that IgG and IgM antibodies to dengue are not present in the specimen or are present
below the detectable levels. Retest in 3-5 days if dengue infection is suspected.
 IgM positive result: The presence of two colored lines ("C" and "M") in the result
window indicates that the
 specimen is positive for IgM antibodies to dengue. This suggests a primary dengue
infection.
 IgG positive result: The presence of two colored lines ("C" and "G") in the result
window indicates that the specimen is positive for IgG antibodies to dengue. This
suggests a secondary or past dengue infection. 
  IgG and IgM positive result: The presence of three colored lines ("C", "M" and "G") in
the result window indicates that the specimen is positive for both IgM and IgG antibodies
to dengue. This suggests a late primary or early secondary dengue infection.
 Invalid result: No Control Line ("C") in the result window means the test is invalid,
whether or not the Test Line ("M" and/or "G") is present. The instructions may not have
been followed correctly or the test may have been compromised. When an invalid result
is obtained, it is recommended that the specimen be retested using a new device.

Test Limitation
1. The level of dengue virus NS1 antigen, IgG and IgM antibodies vary depending on the
stage of the disease. 
 In early infections and some secondary infections, detectable levels of IgM
antibodies may be low. Some patients may not produce detectable levels of
antibody within the first seven to ten days after infection. If the test result is
negative and clinical symptoms persist, a second specimen should be collected, 3-
4 days later from the first specimen collected.
 Anti-NS1 antibodies are produced in some patients. In this case, the detection of
NS1 antigen is inhibited and a negative result may occur.
2. A negative result can occur if the dengue NS1 antigen or dengue antibodies are not
present in the specimen when it is collected or are below the detectable level. A negative
test result does not exclude the possibility of dengue infection.
3. As with all diagnostic tests, results must be considered with other clinical information
available to the physician.
4. Serological cross reactivity across the Flavivirus genus (e.g. West Nile virus, St. Louis
Encephalitis virus, Japanese Encephalitis virus, Yellow Fever virus, Zika virus) is
common. While there was no cross reactivity observed in internal studies (See
Performance Characteristics Section), cross reactivity with the Flavivirus genus must be
considered as possible.
5. Test results can vary according to the time at which the specimen was collected following
onset of symptoms, the specimen type, serotype present in the population tested,
reference method utilized and other factors. These variables must be considered when
comparing studies.

Syphilis 3.0 (Abbott; Bioline)

Test Procedure
1. Allow all kit components and specimens to come to room temperature (15-30 degrees
celcius) prior to testing.
2. Remove the test device from the foil pouch and place it on a flat, dry surface.
3. [Using a micropipette]
Dispense 10µL of plasma or serum specimen (20µL of blood specimen) into the
specimen well (S).
OR,
[Using a capillary pipette]
 Dispense 20µL of drawn blood specimen with a 20µL capillary pipette into the specimen
well (S).
4. Dispense 4 drops (about 120µL) assay diluent into the specimen well(s).
5. As the test begins to work, you will see purple color move across the result window in the
center of the test device.
6. Interpret test results in 5-20 minutes.
Caution: Do not read test results after 20 minutes. Reading test result too late can
yield false results.

TEST INTERPRETATION

1. A colored control band will appear in the left section of the result window to show that
the test is working properly.
2. The right section of the result window indicates the test results. If another colored band
appears in the right section of the result window, this is the test band. 
 Negative result:
The presence of only the control band (C) within the result window indicates a
negative result.

 Positive result:
The presence of the test band (T) and the control band (C) within the result
window, regardless of which band appears first, indicates a positive result.
Caution: The presence of any test line, no matter how faint, the result is
considered positive.

 Invalid result:
If the control band (C) is not visible within the result window after performing the
test, the result is considered invalid. Instructions may not have been followed
correctly or the test may have deteriorated beyond the expiration date. It is
recommended that the specimen be retested using a new test kit.

Test Limitations 

1. The Bioline™ Syphilis 3.0 test will only indicate the presence of TP antibodies in the
specimen and should not be used as the sole criteria for the diagnosis of TP infection.
2. As with all diagnostic tests, all results must be interpreted together with other clinical
information available to the physician.
3. If the test result is negative and clinical symptom persist, additional testing using other
clinical methods is recommended. A negative result does not at any time preclude the
possibility of TP infection.
HIV 1/2 3.0 (Abbott; Bioline)

Test procedure
1. Bring all kit components and specimens to reach a temperature between 15°C and 30°C
prior to testing.
2. Remove the test device from foil pouch and place it on a flat, dry surface. Label the test
device with a patient identifier.
3. [Using a micropipette]
Dispense 10 ul of plasma or serum specimen or dispense 20 ul of whole blood specimen
into the specimen well "S".
OR,
[Using a capillary pipette]
Dispense 20 ul of drawn whole blood specimen into the specimen well "S".
1. Dispense 4 drops (approximately 120 ul) of assay diluent into the specimen well "S".
Caution: Do not let bottle nozzle touch device in order to avoid cross-contamination.
Hold bottle vertically while dispensing. If you do not hold the bottle vertically, it can lead
to inaccurate results. Exactly, 4 drops should be added. Adding more than 4 drops may
result in reddish color background or an invalid result.
2. As the test begins to work, you will see purple color move across the result window in the
center of the test device.
3. Interpret test results 10-20 minutes after adding assay diluent. Do not read after 20
minutes.
Caution: If the test result is not legible after 10 minutes due to high background color,
read again later but within 20 minutes of adding the diluent. Reading outside of this time
frame (before 10 min or after 20 min) may provide false results.

Test interpretation 
1. A colored control line will appear at "C" in the result window to show that the test is
working properly.
2. The "1" and "2" section of the result window indicates the test result.
 Negative result:
The presence of only the control line (C) within the result window indicates a
negative result.
 Positive result:
Caution: The presence of any test line, no matter how faint, the result is
considered positive.
1. HIV-1 positive:
 The presence of both test line 1 (1) and the control line (C) indicates a
positive result for anti-HIV-1.
 If the color intensity of the test line 1 is darker than one of test line 2 in the
result window, you can interpret the result as anti-HIV-1 positive.
2. HIV-2 positive:
 The presence of both test line 2 (2) and the control line (C) indicates a
positive result for anti-HIV-2.
 If the color intensity of the test line 2 is darker than one of test line 1 in the
result window, you can interpret the result as anti-HIV-2 positive.
 3. Both HIV-1 and HIV-2 Positive: The presence of the test line 1 (1), the test line 2 (2)
and the control line (C) indicates a positive result for anti-HIV-1 and/or anti-HIV-2.
        Caution: Although a positive result for anti-HIV-1 and anti-HIV-2 in one patient is a
rare case, it's possible as there is an homology in the amino acid sequence between
anti-HIV-1 and anti-HIV-2. To determine the virus type or diagnose a co-infection
accurately, you must perform a confirmatory test such as Western Blot etc.
 Invalid result:
Absence of the control line (C) and/or presence of a pink/purple smear in the
result window indicates an invalid result. Instructions may not have been
followed correctly or the test may have deteriorated. It is recommended that the
specimen be retested using a new test device.

Test Limitations
1. A positive result may indicate infection with HIV 1/2. Immunochromatographic testing
alone cannot be used to diagnose AIDS. An AIDS diagnosis can only be made in a
clinical setting if an individual meets the case definition for AIDS established by the
Centers for Disease Control (CDC). Positive specimens should be confirmed by a
supplemental assay such as ELISA or Western Blot test.
2. A negative result does not eliminate the possibility of infection with HIV-1 and/or HIV-2.
The specimen may contain low levels of antibodies that cannot be detected by Bioline™
HIV 1/2 3.0 kit. If a test result is negative and clinical symptoms persist, additional
testing using other clinical methods is recommended.
3. Some known HIV-infected persons taking antiretroviral medication have been shown to
produce false negative results when tested by rapid diagnostic tests.
4. Where clinical presentation or other data would suggest an inconsistent test result then
the individual should be tested by nucleic acid testing (NAT) technologies immediately
and/or retested for antibodies to HIV after more than 21 days since the original testing.

HBsAg (Abbott; Bioline)

Test Procedure
1. Allow all kit components and specimen to room temperature (between 15 °C and 30 °C)
prior to testing.
2. Remove the test device from the foil pouch and place it on a flat, dry surface.
3. Dispense 100 μl of plasma or serum specimen into the specimen well.
4. As the test begins to work, you will see purple color move across the result window in the
center of the test device.
5. Interpret test results at 20 minutes.

Test Interpretation 
1.  A purple control band will appear in the left section of the results window to show that
the test is working properly. 
2.  The right section of the results window indicates the test results. If another purple band
appears in the right section of the results window, this is the test band.
  Negative Result: The presence of only control band (C) within the results window
indicates a negative result.

 Positive Result: The presence of the test line (T) and the control line (C) within the
results window, regardless of which band appears first, indicates a positive result.
Caution: The presence of any test line, no matter how faint, the result is considered
positive.

 Invalid Result: If the control band (C) is not visible within the result window after
performing the test, the result is considered invalid. Instructions may not have been
followed correctly or the test may have deteriorated beyond the expiration date. It is
recommended that the specimen be retested using a new test kit.

Test Limitations
A negative result does not preclude the possibility of infection with HBV. Other
clinically available tests are required if questionable results are obtained. As with all diagnostic
tests, a definitive clinical diagnosis should not be based on the results of a single test, but should
only be made by the physician after all clinical and laboratory findings have been evaluated.

HCV (Abbott; Bioline)

Test procedure
1. Bring all kit components and specimens to reach a temperature between 15 °C and 30 °C prior
to testing.
2. Remove the test device from foil pouch and place it on a flat, dry surface. Label the test device
with a patient identifier.
3. [Using a micropipette]
Dispense 10 μl of plasma, serum or whole blood specimen into the specimen well marked "S".
Or, 
[Using a capillary pipette]
Dispense 10 ul of drawn whole blood specimen into the specimen well marked "S" 
4. Dispense 4 drops of assay diluent into the specimen well "S"
 Caution: If you do not hold the bottle vertically, it can lead to inaccurate results. Exactly,
4 drops should be added. Adding more than 4 drops may result in reddish color
background or an invalid result.
5. As the test begins to work, you will see purple color move across the result window in the
center of the test device. 
6. Interpret test results 5-20 minutes after adding assay diluent. Do not read after 20 minutes. 
 Caution: If the test result is not legible after 5 minutes due to high background color, read
again later but within 20 minutes of adding the diluent. Reading outside of this time
frame (before 5 min or after 20 min) may result in false results.

Test Interpretation
1. A colored control line will appear at “C” in the result window to show that the test is
working properly.
2. The “T” section of the result window indicates the test result.
 Non- reactive result: the presence of only the control line (C) within the result window
indicates a non-reactive result.
 Reactive result: the presence of the test line  (T) and the control line (C) within the result
window, regardless of which line appears first, indicates reactive result.
 Caution: The presence of any test line, no matter how faint, the result is
considered reactive.
  Invalid result: if the control line (C) is not available within the result window after
performing the test, the result is considered invalid. Instructions may not have been
followed correctly or the test may have deteriorated . It is recommended that the
specimen be retested using a new test device.   

Test Limitations
1. A non-reactive result does not preclude the possibility of infection with HCV. Other
clinically available tests are required if questionable results are obtained. As with all
diagnostic tests, a definitive clinical diagnosis should not be based on the result of a
single test, but should only be made by the physician after all clinical and laboratory
findings have been evaluated.
2. Due to the inherent design of qualitative IVD tests, a faint or absent test line (false non-
reactive) may occur in specimens containing high antibody densities; the prozone effect.
In order to obtain a definitive result, all clinical and laboratory findings should be
evaluated.

Salmonella typhi IgG/IgM

1. Dispense 4 drops (90-120 ul) of diluent assay to the disposable tube
2. With a loop provided dispense 1 ul of specimen into the tube containing the diluent assay.
3. Gently stir and mix.
4. Holding the strip vertically, insert or dip the test strip into the tube
5. Interpret test results at 15-30 minutes

Troponin I (Qualitative)
1. Dispense 80-100 uL of specimen into the specimen well.
2. Interpret test result at 15-20 minutes

Troponin I (Quantitative)

1. Preparation
Ensure that the lot number of Test Cartridge matches the lot number of ID Chip as well as
the Buffers. Insert ID Chip into Finecare FIA Meters. Be aware not to touch the insertion
tip of the lD chip.

2. Sampling
Draw 75 uL serum, plasma or whole blood with a transfer pipete and add it to the
Detection Buffer Tube.

3. Mixing
Close the lid of Detection Buffer Tube and mix the sample mixture thoroughly by
shaking it about 10 times.

4. Loading
Draw 75 uL sample mixture and load it into the sample well of Test Cartridge.