HBsAg cassette

CONTENTS HBsAg
A rapid test for the qualitative detection of Hepatitis B
Surface Antigen (HBsAg) in serum or plasma
REF 4255240 HBsAg 40 Tests
ONE STEP
For professional use only

PRINCIPLE MATERIAL REQUIRED

The LINEAR HBsAg cassette is a lateral flow chromatographic  Timer.
immunoassay for the qualitative detection of Hepatitis B surface
antigen (HBsAg) in human serum or plasma at the level equal to or  Specimen collection container.
higher than 1 ng/ml. It is intended to be used as a screening test  General laboratory equipment.
and as an aid in the diagnosis of infection with Hepatitis B virus
(HBV). Any reactive specimen with the HBsAg cassette must be PROCEDURE
confirmed with alternative testing method(s) and clinical findings. Allow test device, serum or plasma specimen, and/or controls
The LINEAR HBsAg cassette detects HBsAg through visual to equilibrate to room temperature (15-30°C) prior to testing.
interpretation of color development on the internal strip. Anti- 1. When ready to test, open the pouch at the notch and remove
HBsAg antibodies are immobilized on the test region of the the device. Place the test device on a clean, flat surface.
membrane. During testing, the specimen reacts with anti-HBsAg
antibodies conjugated to colored particles and pre-coated onto the 2. Be sure to label the device with specimen’s ID number.
sample pad of the test. The mixture then migrates through the 3. Fill the plastic dropper with the specimen. Holding the plastic
membrane by capillary action, and interacts with reagents on the dropper vertically, dispense 2 drops (about 60-90 µL) of
membrane. If there is enough HBsAg in the specimen, a colored specimen into the sample well (S). (Note)
band will form at the test region of the membrane. The presence of Avoid trapping air bubbles in the specimen well (S), and
this colored band indicates a positive result, while its absence do not add any solution to the result window.
indicates a negative result. The appearance of a colored band at 4. As the test begins to work, color will migrate across the
the control region serves as a procedural control, indicating that the membrane.
proper volume of specimen has been added and membrane 5. Wait for the colored band(s) to appear. The result should be
wicking has occurred. read at 15 minutes.
Do not read result after 20 minutes. To avoid confusion,
REAGENT COMPOSITION discard the test device after interpreting the result.
HBsAg test device, contains protein A and anti-HBsAg antigen
coated on the membrane.

PACKAGING CONTENTS
REF 4255240 40 HBsAg test device
40 Plastic specimen droppers

STORAGE AND STABILITY Result

2 Drops of Serum/Plasma
Store at 2-30ºC. The test cassette is stable through the 15 minutes
expiration date printed on the sealed pouch. The test cassette must
INTERPRETATION OF RESULTS
remain in the sealed pouch until use. DO NOT FREEZE. Do not
use beyond the expiration date or devices with damaged pouch. POSITIVE: * Two distinct red lines appear. Two colored bands
Care should be taken to protect the components of the kit from appear on the membrane. One band appears in the control region
contamination. (C) and another band appears in the test region (T).
SPECIMEN COLLECTION AND PREPARATION
 LINEAR HBsAg cassette is intended for use with human
serum or plasma specimens only.
 Only clear, non-hemolyzed specimens are recommended for
use with this test. Serum or plasma should be separated as
NEGATIVE: Only one colored band appears, in the control region
soon as possible to avoid hemolysis.
(C). No apparent colored band appears in the test region (T).
 Perform testing immediately after specimen collection. Do not
leave specimens at room temperature for prolonged periods.
Specimens may be stored at 2-8°C for up to 3 days. For long
term storage, specimens should be kept below -20°C.
 Bring specimens to room temperature prior to testing. Frozen
specimens must be completely thawed and mixed well prior to
testing. Avoid repeated freezing and thawing of specimens. INVALID: Control line fails to appear. Results from any test which
 If specimens are to be shipped, pack them in compliance with has not produced a control band at the specified read time must be
all applicable regulations for transportation. discarded. Please review the procedure and repeat with a new test.
 Icteric, lipemic, hemolysed, heat treated and contaminated If the problem persists, discontinue using the kit immediately and
sera may cause erroneous results. contact your local distributor.

QUALITY SYSTEM CERTIFIED LINEAR CHEMICALS, S.L.U. Joaquim Costa 18 2ª planta. 08390 Montgat (Barcelona) SPAIN
ISO 9001 ISO 13485 Telf. (+34) 934 694 990; E-mail: info@linear.es ; website: www.linear.es NIF-VAT:B60485687
 PRECAUTIONS
1. This package insert must be read completely before
performing the test. Failure to follow the insert gives
NOTE: inaccurate test results.
The HBsAg Rapid Test is limited to the qualitative detection of 2. Do not use the components in any other type of test kit as a
substitute for the components in this kit.
HBsAg in human serum or plasma. The intensity of the test line
does not have a linear correlation with the HBsAg titer in the 3. Do not use hemolized blood specimens for testing.
specimen. 4. Wear protective clothing and disposable gloves while handling
the kit reagents and clinical specimens. Wash hands
QUALITY CONTROL thoroughly after performing the test.
5. Users of this test should follow the US CDC Universal
An internal procedural control is included in the test. A colored line Precautions for prevention of transmission of HIV, HBV and
appearing in the control region (C) is considered an internal positive other blood-borne pathogens.
procedural control. It confirms sufficient specimen volume and 6. Do not smoke, drink or eat in areas where specimens or kit
correct procedural technique. reagents are being handled.
External controls are not supplied with this kit. It is recommended 7. Dispose of all specimens and materials used to perform the
that positive and negative controls should be tested as a good test as bio-hazardous waste.
laboratory practice to confirm the test procedure and to verify 8. Handle the negative and positive controls in the same manner
proper test performance. Handle the negative and positive controls as patient specimens.
in the same manner as patient specimens. 9. Do not perform the test in a room with strong air flow, i.e.
electric fan or strong air-conditioning.
CLINICAL SIGNIFICANCE
LIMITATIONS OF THE PROCEDURE
Hepatitis B virus (HBV) is the prototypic member of the
hepadnaviruses. Hepatitis B surface antigen (HBsAg) is located in 1. The Assay Procedure and the Interpretation of Assay Result
the lipid envelope of this small DNA virus. During the replicative sections must be followed closely. Failure to follow the
phase of the virus, this surface antigen is produced in excess and is procedure may give inaccurate results.
detectable in the blood of the infected. The incubation period of 2. LINEAR HBsAg is a screening test. This screening test should
HBV is 6 weeks to 6 months. be used for the detection of HBsAg in serum or plasma
specimen. Neither the quantitative value nor the rate of HbsAg
ANALYTICAL PERFORMANCE concentration can be determined by this qualitative test.
3. A non-reactive test result does not preclude the possibility of
1. Clinical Performance. A total of 560 samples from exposure to or infection with HBV.
susceptible subjects were tested with the Linear HBsAg
4. LINEAR HBsAg will only indicate the presence of HBsAg in
Cassette and with a commercial HBsAg ELISA kit with a test
sensitivity of 0.5 ng/mL. Comparison for all subjects is shown the specimen and should not be used as the sole criteria for
in the following table. the diagnosis of Hepatitis B viral infection.
5. If the test result is negative and clinical symptoms persist,
HBsAg Cassette additional testing using other clinical methods is
HBsAg ELISA Positive Negative Total
recommended. A negative result does not at anytime rule out
Positive 97 0 97
463
the presence of HBsAg in blood, as HBsAg may be present
Negative 0 463
Total 97 463 560 below the minimum detection level of the test.
6. As with all diagnostic tests, a confirmed diagnosis should only
2. Cross-Reactivity. Cross-reactivity with specimens from other be made by a physician after all clinical and laboratory
infectious diseases: findings have been evaluated.
Specimen Sample Size HBsAg Reactivity
7. Some specimens containing unusually high titers of
Dengue Positive Serum 10 Negative heterophile antibodies or rheumatoid factor may affect
HAV Positive Serum 10 Negative expected results.
HCV Positive Serum 10 Negative
HIV Positive Serum 10 Negative NOTE
Syphilis Positive Serum 10 Negative
TB Positive Serum 10 Negative Add 1 drop of Saline or Phosphate-Saline buffer (common buffers
H. pylori Positive Serum 10 Negative used in clinic not provided in the kit) into the sample well if flow
ANA Positive Serum 6 Negative
HAMA Positive Serum 4 Negative
migration is not observed within 30 seconds in the result window,
RF Positive Serum (≤2,500 IU/ml) 3 Negative which could occur with a highly viscous specimen.

3. Interference. Common substances (such as pain and fever REFERENCES

medication and blood components) may affect the
performance of the Linear HBsAg Cassette. This was studied 1. Emanuel Rubin and John Farber. The liver and biliary system.
by spiking these substances into three levels of HBsAg Acute viral hepatitis P 721-729. Rubin E, Farber JL ed.
standard controls. The results are presented in the following Pathology 2nd ed. 1994. J.B. Lippincott, Philadelphia
table and demonstrate that at the concentrations tested, the 2. Kaplan PM, Greenman RL, Gerin JL, Purcell RH, Robinson
substances studied do not affect the performance of the Linear WS. DNA polymerase associated with human hepatitis B
HBsAg Cassette. antigen. J Virol. 1973 12(5):995-1005.
Note: -: Negative; +: Positive; ++: Medium Positive 3. Dane DS, Cameron CH, Briggs M. Virus-like particles in
HBsAg Reactivity serum of patients with Australia-antigen-associated hepatitis.
Potential Interfering
Substances Spiked Negative
Weak Medium Lancet. 1970;1(7649):695-8.
Positive Positive
Control - + ++
4. Magnius LO, Espmark A. A new antigen complex co-occurring
Bilirubin 20 mg/dL - + ++ with Australia antigen. Acta Pathol Microbiol Scand [B]
Creatinine 442 µmol/L - + ++ Microbiol Immunol. 1972;80(2):335-7
Glucose 55 mmol/L - + ++
Albumin 50 g/L - + ++
Salicylic Acid 4.34 mmol/L - + ++
O4255-7/1502
Heparin 3,000 U/L - + ++ R1.ing
EDTA 3.4 µmol/L - + ++
Human IgG 1,000mg/dL - + ++
Sodium citrate 3.8% - + ++

QUALITY SYSTEM CERTIFIED LINEAR CHEMICALS, S.L.U. Joaquim Costa 18 2ª planta. 08390 Montgat (Barcelona) SPAIN
ISO 9001 ISO 13485 Telf. (+34) 934 694 990; E-mail: info@linear.es ; website: www.linear.es NIF-VAT:B60485687