B.

HBsAb / Anti-HBs (vaxpert) PRECAUTIONS

➔ Allow test cassette, serum, or plasma specimens, and/or Please read all the information in this package insert
controls to equilibrate to room temperature (15-30 C) before
prior to testing. performing the test.
1. Remove the test cassette from the sealed foil pouch 1. For professional in vitro diagnostic use only. Do not use
and use it as soon as possible. Best results will be after the expiration date.
obtained if the assay is performed immediately after 2. Do not eat, drink or smoke in the area where the
opening the foil pouch. specimen or kits are handled.
2. Hold the dropper vertically and transfer 3 drops of 3. Handle all the specimens as if they contain infectious
serum/plasma (approximately 75 µL) to the specimen agents. Observe established precautions against
well of test device and start the timer. Avoid trapping microbiological hazards throughout testing and follow
air bubbles in the specimen well. the standard procedures for proper disposal of specimen.
3. Wait for the colored line to appear. The result should 4. Wear protective clothing such as laboratory coats,
be read at 15 minutes. Do not interpret the result after disposable gloves, and eye protection when specimens
20 minutes. are being tested
HBsAb (Package Insert) 5. Humidity and temperature can adversely affect results.
Specimen Serum/Plasma STORAGE AND STABILITY
INTENDED USE ➔ Store as packaged at room temperature or refrigerated
➔ The HBsAb Rapid Test Cassette (Serum/Plasma) is a (2-
rapid 30°C). The test is stable through the expiration date
chromatographic immunoassay for the qualitative printed
detection on the sealed pouch. The test must remain in the sealed
of Antibody to Hepatitis B Surface Antigen in serum or pouch until use. DO NOT FREEZE, Do not use beyond the
plasma. expiration date.
SUMMARY SPECIMEN COLLECTION AND PREPARATION
➔ Viral hepatitis is a systemic disease primarily involving 1. The HBsAb Rapid Test Cassette can be performed using
the serum or plasma.
liver. Most cases of acute viral hepatitis are caused by 2. Separate serum or plasma from blood as soon as
Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C possible
virus. to avoid hemolysis. Use only clear, non-hemolyzed
The complex antigen found on the surface of HBV is called specimens.
HBsAg. The presence of HBsAg in serum or plasma is an 3. Testing should be performed immediately after
indication of an active Hepatitis B infection, either acute or specimen
chronic. The antibody to HBsAg, HBsAb, may not become collection. Do not leave the specimens at room
detectable for 3-6 months after acute infection. It is temperature for prolonged periods. Serum and plasma
associated with resolution of the illness. This antibody is specimens may be stored at 2-8°C for up to 3 days, For
recognized as the marker of immunity to HBV. As a result, long term storage, specimens should be kept below -
vaccination against HBV was introduced to control the 20°C.
morbidity and mortality associated with the virus. As part 4. Bring specimens to room temperature prior to testing.
of Frozen specimens must be completely thawed and
the World Health Organization (W.H.O) problem for the mixed well prior to testing. Specimens should not be
control of Hepatitis B, many people, especially new born frozen and thawed repeatedly.
infants, receive vaccination. The minimum standard titer of 5. If specimens are to be shipped, they should be packed in
HBsAb is 10 mIU/mL for protective immunity to HBV. compliance with federal regulations covering the
Unfortunately, approximately 5-15% of healthy transportation of etiologic agents.
immunocompetent individuals either does not exhibit an MATERIALS
antibody response to the existing recombinant vaccination ➔ Materials Provided
or respond poorly. The HBsAb Rapid Test Cassette ◆ Test Cassettes
(Serum/Plasma) is a rapid test to qualitatively detect the ◆ Droppers
presence of HBsAb in serum or plasma specimen. The test ◆ Package insert
utilizes a double antigen sandwich system to detect as low ➔ Materials required but not provided
as ◆ Specimen collection containers
10mIU/ml of HBsAb in serum or plasma. ◆ Centrifuge
PRINCIPLE ◆ Timers
DIRECTIONS FOR USE
➔ Allow test cassette, serum or plasma specimen, and/or
➔ The HBsAb Rapid Test Cassette (Serum/Plasma) is a controls to equilibrate to room temperature (15-30C) prior
qualitative, lateral flow immunoassay for the detection of to testing.
HBsAb in serum or plasma, The membrane is pre-coated 1. Remove the test cassette from the sealed foil pouch and
with HBsAg on the test line region of the strip. During use it as soon as possible. Best results will be obtained if
testing, the serum or plasma specimen reacts with the the assay is performed immediately after opening the foil
particle coated with HBsAg. The mixture migrates upward pouch.
on 2. Hold the dropper vertically and transfer 3 drops of
the membrane chromatographically by capillary action to serum
react with HBsAg on the membrane and generate a or plasma (approximately 75 uL) to the specimen well of
colored test device and start the timer. Avoid trapping air bubbles
line. The presence of this colored line in the test region in the specimen well.
indicates a positive result, while its absence indicates a 3. Wait for the colored line is to be appeared. The result
negative result. To serve as a procedural control, a colored should be read at 15 minutes. Do not interpret the result
line will always appear in the control line region indicating after 20 minutes.
that proper volume of specimen has been added and INTERPRETATION OF RESULTS
membrane wicking has occurred.
REAGENTS
➔ The test cassette contains HBsAg particles and HBsAg
coated on the membrane.
 HBsAb Rapid Test Cassette (Serum/Plasma) has
Negative ➔ One colored line appears in the control been tested over a 10 days period using negative,
region (C). No apparent colored line low positive and high positive specimens. The
appears in the test region (T) specimens were correctly identified 99% of the
Positive time.
➔ Two distinct colored lines appear. One ➔ Cross-reactivity
colored line should be in the control The HBsAb Rapid Test Cassette (Serum/Plasma)
region (C) and another colored line has been tested by HAMA, Rheumatoid factor
should be in the test region (T). (RF), HAV, Syphilis, HIV, H. Pylori, MONO, CMV,
◆ *NOTE: The intensity of the Rubella and TOXO positive specimens. The
color in the test line region (T) results showed no cross-reactivity
will vary depending on the ➔ Interfering Substances
concentration of HBsAb
present in the specimen.
Therefore, any shade of color in
the test region (T) should be
considered positive. The HBsAb Rapid Test Cassette (Serum/Plasma)
Invalid has been tested for possible interference from
➔ Control line fails to appear. Insufficient visibly hemolyzed and lipemic specimens. No
specimen volume or incorrect interference was observed. In addition, no
procedural techniques are the most interference was observed in specimens
likely reasons for control line failure. containing up to 2,000 mg/dL Hemoglobin, 1000
Review the procedure and repeat the mg/dL Bilirubin, and 2000 mg/dL human serum
test with a new test cassette. If the Albumin.
problem persists, discontinue using the C. Rapid Anti-HCV test
test kit immediately and contact your Rapid Anti-HCV test (Package Insert)
local distributor. Specimen Serum/Plasma
QUALITY CONTROL INTENDED USE
➔ Internal procedural controls are included in the test. A ➔The advanced quality tm rapid anti-HCV test is a colloidal
colored line appearing in the control region (C) is an gold enhanced, rapid immunochromatographic assay for
internal positive procedural control. It confirms sufficient the
specimen volume and correct procedural technique. qualitative detection of antibodies to hepatitis c virus
➔ Control standards are not supplied with this kit; (HCV)
however, in human serum or plasma. This test is a screening test and
it is recommended that positive and negative controls be all positives must be confirmed using an alternate test such
tested as a good laboratory practice to confirm the test as western blot the test is intended for healthcare
procedure and to verify proper test performance. professional use only.
LIMITATIONS SUMMARY
1. The HBsAb Rapid Test Cassette (Serum/Plasma) is for in ➔ The general method of detecting infection with HCV is
vitro diagnostic use only. This test should be used for the to
detection of HBsAb in serum or plasma specimen. observe the presence of antibodies to the virus by an EIA
2. The HBsAb Rapid Test Cassette (Serum/Plasma) cannot method followed by confirmation with Western Blot. The
detect less than 10mlU/ml of HBsAb in specimens. ADVANCED QUALITY Rapid Anti-HCV Test is a simple,
3. As with all diagnostic tests, all results must be visual qualitative test that detects antibodies in human
considered serum or plasma. The test is based on
with other clinical information available to the physician. immunochromatography and can give a result within 15
EXPECTED VALUES minutes
➔ The HBsAb Rapid Test Cassette (Serum/Plasma) has PRINCIPLE OF THE PROCEDURE
been ➔ The assay starts with a sample applied to the sample
compared with a leading commercial HBsAb RIA test. The well
correlation between these two systems is 97.3%. and add provided sample diluent immediately.
PERFORMANCE CHARACTERISTICS ➔ The HCV antigen-colloidal gold conjugate embedded in
➔ Sensitivity the
◆ The HBsAb Rapid Test Cassette (Serum/Plasma) sample pad reacts with the HCV antibody present in serum
has been tested with a sensitivity panel ranging or plasma sample forming conjugate/HCV antibody
from 1mlU/ml to 40m|U/ml. The test can complex.
detect 10m|U/ml of HBsAb in 15 minutes. ➔ As the mixture is allowed to migrate along the test strip,
➔ Specificity the
◆ Antigen used for the HBsAb Rapid Test Cassette conjugate/HCV antibody complex is captured by a
(Serum/Plasma) is highly specific for detecting antibody-binding protein A immobilized on a membrane
HBsAb in serum or plasma. The specificity was forming a colored test band in the test region.
comparable to RIA. ➔ A negative sample does not produce a test line due to
➔ Precision the
➔ Intra-Assay absence of colloidal gold conjugate/HCV antibody complex.
Within-run precision has been determined by ➔ The antigens used in the test are recombinant proteins
using 15 replicates of three specimens containing corresponding to highly immunoreactive regions of HCV. A
negative, low positive and high positive. The colored control band in the control region appears at the
negative and positive values were correctly end of test procedure regardless of test result. This control
identified 99% of the time. band is the result of colloidal gold conjugate binding to a
➔ Inter-Assay anti-HCV antibody immobilized on the membrane. The
Between-run precision has been determined by control line indicates that the colloidal gold conjugate is
using the same three specimens of negative, low functional. The absence of the control band indicates that
positive and high positive of HBsAb in 15 the test is invalid.
independent assays. Three different lots of the REAGENTS AND MATERIALS SUPPLIED
➔ Test cards/ test strips individually foil pouched with a
desiccant device
➔ Plastic dropper Note. It is normal to have a slightly lightened
➔ Sample Diluent control band with very strong positive samples
➔ Package Insert as long as it is distinctly visible
MATERIALS REQUIRED BUT NOT PROVIDED PERFORMANCE CHARACTERISTICS
➔ Positive controls ➔ Sensitivity
➔ Negative controls ◆ In the same studies mentioned above, Advanced
STORAGE AND STABILITY Quality Rapid Anti- HCV Test was evaluated with
➔ The kit must be stored at 2-30°C 61 confirmed positive serum samples (USA: 31
WARNINGS AND PRECAUTIONS samples and China 30 samples) All 61 samples
1. ALL positive results must be confirmed by an alternative were found reactive
method. ➔ Specificity
2. Treat all specimens as though potentially infectious. ◆ The specificity of the Advanced Quality Rapid
Wear Anti-HCV Test is based on clinical studies using
gloves and protective clothing when handling specimens confirmed negative serum samples from blood
3. Devices used for testing should be autoclaved before bank and hospital patients in the USA (66
disposal samples) and China (90 samples).
4. Do not use kit materials beyond their expiration dates 5. ◆ The studies were performed comparing the
5. Do not interchange reagents from different lot of kit results from the Advanced Quality Rapid AntiHCV test and
SAMPLE COLLECTION AND STORAGE that from Abbott's ELISA as a
1. Collect serum or plasma specimens following regular reference test. The overall specificity was found
clinical laboratory procedures. to be 97-99
2. Storage. A specimen should be refrigerated if not used LIMITATIONS
the same day of collection Specimens should be frozen if 1. Only samples that are clear and with good fluidity can
not used within 3 days of collecting Avoid freezing and be
thawing the specimens more than 2-3 times before using used in this test
0.1% of sodium azide can be added to specimen as
preservative without affecting the results of the assay.
BEFORE TESTING
1. Bring the device, sample diluent, and specimens to
room 2. Fresh samples are best but frozen samples can be used if
temperature a sample has been frozen, it should be allowed to thaw in
a vertical position.
3. Do not agitate the sample Insert a pipette just below the
surface of the sample to collect the specimen
4.
2. Remove the test card from the sealed pouch. D. Anti-HIV 1 & 2
ASSAY PROCEDURES If test cards:
If test cards: 1. Bring all reagents and specimens to room temperature.
1. Dispense 1 drop (10 µL) of serum or plasma to the “S” 2. Remove the test card from the foil pouch and place on
well of the test card using the plastic dropper a clean dry surface.
provided. 3. Identify the test card for each specimen or control.
2. Add two drops of Sample Diluent to the “D” well 4. Dispense 100 µL (3 drops) of the specimen into the
immediately after the specimen is added. sample well on the card.
3. Interpret test results at 15 minutes. 5. Interpret test results at 15 minutes.
For test strips: If test strips:
1. Dispense 1 drop(10µl) of serum or plasma to the upper 1. Bring all reagents and specimens to room temperature.
edge of the sample pad of the test strip using the plastic 2. Remove the test strip from the foil pouch and place on
dropper provided according to the figure. a clean dry surface.
2. Add two drops of Sample Diluent to the lower edge of 3. Apply at least 80 µL of specimen (serum/plasma) to
the sample pad after the specimen is added. the sample pad behind the mark at the bottom of
3. Interpret test results at 15 minutes. test strip.
Notes: 4. Interpret test results at 15 minutes.
1. Applying sufficient amount of sample diluent is essential Anti-HIV 1 & 2 Test (Package Insert)
for a valid test result. If migration (the wetting of FOR IN VITRO DIAGNOSTIC USE
membrane) is not observed in the test window after one INTENDED USE
minute, add one more drop of diluent to sample well ➔ The advanced quality one step anti-hiv(1&2) test is a
2. The positive results could appear as soon as 1 minute for colloidal
a sample with high levels of HCV antibodies. gold enhanced, rapid immunochromato- graphic assay for
3. Do not interpret result after 20 minutes the qualitative detection of antibodies to human
READING THE TEST RESULTS immunodeficiency virus (hiv) in human serum or plasma.
Negative ➔ Only the purplish red control band this
appears on the membrane. The absence test is a screening test, and all positives must be confirmed
of a test band indicates a negative result using an alternate test such as western blot the test is
Positive intended for healthcare professional use only.
➔ Both purplish red test band and SUMMARY
purplish red control band appear on the ➔ The human immunodeficiency virus HIV(182) is the
membrane. The lower the antibody causative agent of acquired immune deficiency syndrome
concentration, the weaker the test band (AIDS). The general method of detecting infection with HIV
Invalid is to observe the presence of antibodies to the virus by an
➔ There should always be a purplish red EIA method followed by confirmation with Western Blot.
control band in the control region The
regardless of test result. If the control Advanced Quality One Step Anti-HIV(182) Test is a simple,
band is not seen the test is considered visual qualitative test that detects antibodies in human
invalid. Repeat the test using a new test
serum or plasma. The test is based on 4. Apply at least 80 µl of specimen to the sample pad
immunochromatography and can give a result within 1 to behind
15 minutes. the (111) mark at the bottom of test strip.
TEST PRINCIPLE 5. Interpret test results at 15 minutes.
➔ The assay starts with a sample applied to the sample Caution
well. ➔ Use a clean pipette or tip for every sample to avoid
A recombinant HIV antigen conjugated to colloidal gold crosscontamination.
embedded in the sample pad reacts with the HIV antibody ➔ NOTE: A positive result may be interpreted early,
present in serum or plasma forming conjugate/HIV however
antibody complex. read any negative at 15 minutes to ensure sample is
➔ As the mixture is allowed to migrate along the test strip, negative
the conjugate/HIV antibody complex is captured by and not a low concentration of the anti-HIV antibody. Do
recombinant HIV antigen immobilized on a membrane not interpret the result after 20 minutes.
forming a colored test band in the test region. ◆ It is recommended to run a known positive
➔ A negative sample does not produce a test band due to control and negative control in each performance
the absence of colloidal gold conjugate/HIV antibody to ensure the assay procedure.
complex. The antigens used in the conjugate test are INTERPRETATION OF RESULTS
recombinant proteins that correspond to highly Negative Both purplish red test band and purplish red
immunore- active regions of HIV1 and HIV2. control band appear on the membrane. The
➔ A colored control band in the control region appears at lower the antibody concen- tration, the
the end of test procedure regardless of test result. This weaker the test band.
control band is the result of colloidal gold conjugate Positive
binding to the anti-HIV antibody immobilized on the In addition to the control purplish red test
membrane. The control band indicates that the colloidal band, a distinct purplish red test band also
gold conjugate is functional. appears in the test region
REAGENTS AND MATERIALS SUPPLIED Invalid
● Test cards/ test strips individually foil pouched with a There should always be a purplish red control
desiccant band in the control region regardless of test
● Package Insert result. If the control band is not seen, the test
● Sample dispensing plastic dropper with each test pouch. is considered invalid. Repeat the test using a
(for card only) new test device.
MATERIALS REQUIRED BUT NOT PROVIDED Note: It is normal to have a slightly lightened
● Pipettes control band with very strong positive samples
● Positive and negative controls as long as it is distinctly visible.
STORAGE & STABILITY PERFORMANCE CHARACTERISTICS
➔ The kit must be stored at 2-30 C 1. Specificity
WARNINGS AND PRECAUTIONS ➔ In an in-house laboratory study, 63 confirmed negative
1. ALL positive results must be confirmed by an alternate samples were evaluated with the Advanced Quality One
method. Step Anti-HIV(182) Test using EIA and Western Blot as
2. Treat all specimens as though potentially infectious. reference tests. The study gave 100% specificity for the
Wear test.
gloves and protective clothing when handling specimens. 2. Sensitivity
3. Devices used for testing should be autoclaved before ➔ In the above-mentioned study. Advanced Quality One
disposal Step Anti- HIV(1&2) Test was evaluated with 32 confirmed
4. Do not use kit materials beyond their expiration dates positive samples. The sensitivity of Advanced Quality One
5. Do not interchange reagents from one kit lot to another Step Anti-HIV(1&2) Test was found to be 100% relative to
SAMPLE COLLECTION AND STORAGE consensus with EIA results. supported by Western Blot
1. Collect serum or plasma specimens following regular assay.
clinical laboratory procedures. LIMITATIONS
2. Storage: A specimen should be refrigerated if not used 1. Only samples that are not hemolyzed and that are with
the good fluidity can be used in this test.
same day of collection. Specimens should be frozen if not 2. Fresh samples are best but refrigerated and frozen
used within 3 days of collecting. Avoid freezing and samples can be used.
thawing the specimens more than 2-3 times before using. 3. Do not agitate the sample. Insert a pipette just below
0.1% of sodium azide can be added to specimen as the
preservative without affecting the results of the assay. surface of the sample to collect the specimen.
HAV
IgG/IgM
HBsAb /
ASSAY PROCEDURE Anti-HBs
Do not open the pouch until you are ready to test the (vaxpert)
sample. Anti-HCV Anti-HIV
For test cards: 1&2
1. Bring all reagents and specimens to room temperature. Test Principle
2. Remove the test card from the foil pouch and place on a
clean dry surface.
3. Identify the test card for each specimen or control.
4. Dispense 100μl (3 drops) of the specimen or control into
the sample well on the card. Type of specimen
5. Interpret test results at 15 minutes. used (whole
For test strips: blood/plasma/ser
1. Bring all reagents and specimens to room temperature. um)
2. Remove the test strip from the foil pouch and place on a Serum/
clean dry surface. Plasma
3. Identify the test strip for each specimen or control.
Serum/ used (whole
Plasma blood/plasma/seru
Serum/ m)
Plasma Serum/
Serum/ Plasma
Plasma Serum/
Amount of Plasma
specimen needed Amount of specimen
(number of drops needed (number of
or exact volume) drops or exact
5 µL 75 µL (3 volume)
drops) 1 drop (10 µL) 1 drop (10 µL)
1 drop (10 Amount of sample
µL) diluent used
100 µL (3 (number of drops)
drops) 2 drops 2 drops
Amount of sample Presence of Sample
diluent used well
(number of drops) none none.
2 drops none 2 drops none Presence of D
Presence of (diluent) or B (buffer)
Sample well well
Present Present Present Present none. None
Presence of D Duration of
(diluent) or B incubation before
(buffer) well result is read
B (buffer) 15 minutes 15 minutes
well is How the positive
present result is displayed
none Present None Two distinct lines Two distinct lines
Duration of How the negative
incubation before result is displayed
result is read One line only
15 minutes 15 minutes 15 minutes 15 minutes (control)
How the positive One line only
result is displayed (control
Two
distinct
lines in the
result
window
Two distinct
lines in the
result
window
Two
distinct
lines in
the result
window
Two
distinct
lines in
the result
window
How the negative
result is displayed
One line
on the
control
only
One line on
the control
only
One line
on the
control
only
One line
on the
control
only
Anti-HCV (test strip) Anti-HIV 1 & 2(test
strip)
Type of specimen