LordsMed HBsAg Rapid Test

(Wholeblood/Serum/Plasma)

Catalog No. Pack Size Specimen Type PRECAUTIONS

HBSLMR01 25 Test Device WholeBlood/Serum/Plasma For in Vitro Diagnostic Use
1. This package insert must be read completely before
HBSLMR02 50 Test Device WholeBlood/Serum/Plasma performing the test. Failure to follow the insert may lead to
HBSLMR03 25 Test Device Serum/Plasma inaccurate test results.
HBSLMR04 50 Test Device Serum/Plasma 2. Do not open the sealed pouch unless ready to conduct
the assay.
3. Do not use expired devices.
INTENDED USE
4. Do not use the components in any other type of test
LordsMed HBsAg Rapid Test is a lateral flow chromatographic
kit as a substitute for the components in this kit.
immunoassay for the qualitative detection of hepatitis B
5. Do not use haemolysed blood specimens for testing.
surface antigen (HBsAg) in human serum/plasma/whole
6. Wear protective clothing and disposable gloves while
blood at a level equal to or higher than 1 ng/mL. It is
handling the kit reagents and clinical specimens.
intended to be used as a screening test and as an aid in the
Wash hands thoroughly after performing the test.
diagnosis of infection with hepatitis B virus (HBV). It is
7. Users of this test should follow the US CDC Universal
intended for professional use.
Precautions for prevention of transmission of HIV, HBV,
and other blood-borne pathogens.
TEST PRINCIPLE
8. Do not smoke, drink, or eat in areas where specimens or
The HBsAg Rapid Test is a lateral flow chromatographic
kit reagents are being handled.
immunoassay. Each test contains a strip composed with
9. Dispose of all specimens and materials used to perform
absorbent pad, nitrocellulose membrane, conjugate pad
the test as bio-hazardous waste.
and sample pad. After addition of the
10. Handle the negative and positive controls in the same
serum/plasma/whole blood sample and Assay buffer (for
manner as patient specimens.
whole blood) to the sample well of the device containing a
test strip, the sample moves on to the conjugate pad
SPECIMEN COLLECTION AND STORAGE
containing colloidal gold particles conjugated with HBsAg
Store serum/plasma specimens at 2-8°C if not tested
specific Antibody and Rabbit IgG. If the sample contains
immediately. Fresh wholeblood specimen is required.
detectable levels of the HBsAg Antigen, it reacts with the
Serum/plasma specimens can be stored at 2-8°C for up to
gold conjugated HBsAg specific Antibody to form a
5 days. The serum/plasma specimens should be frozen at -
complex. This complex moves further and reacts with
20°C for longer storage. Avoid multiple freeze-thaw
HBsAg specific Antibody coated as test line on the
cycles. Prior to testing, bring frozen specimens to room
nitrocellulose membrane to form colored band (test line).
temperature slowly and mix gently. Serum/plasma
The unbound complex and the rabbit IgG conjugated
Specimens containing visible particulate matter should be
colloidal gold particles move further to the goat anti-rabbit
clarified by centrifugation before testing.
IgG coated control area to form a colored band (Control
line). The appearance of test line and control line in
PROCEDURE
respective area indicates the positive result. Appearance of
For LordsMed HBsAg Rapid Test
only control line indicates a negative result. The control
1. Bring the specimen and test components to room
line acts as a procedural control. Control line should always
temperature if refrigerated or frozen.
appear if the test is performed as per the procedure and
2. When ready to test, open the pouch at the notch and
reagents are working properly.
remove the device. Place the test device on a clean, flat
surface.
MATERIALS PROVIDED
3. Be sure to label the device with the specimen ID number.
1. Test device.
4(a). Serum/Plasma: Place the device on flat plane surface
2. Desiccant.
& add 2 drops (Approx. 60 µl) of serum or plasma sample in
3. Plastic dropper.
well “S”.
4. Buffer Bottle (Only for Wholeblood Specimen)
4(b). Wholeblood: Place the device on flat plane surface &
5. Package insert (instruction for use)
add 2 drops (Approx.60 µl) of whole blood sample in
MATERIALS REQUIRED BUT NOT PROVIDED well “S” & Add 1 drop of Assay buffer in well “S”.
1. Clock or Timer 5. Set up timer.
6. Read the result at 15 minutes. Do not read the result after 20
minutes.
Note: Use assay buffer for wholeblood samples only.

Lord's Mark Industries Ltd., Plot No. A71, Royal Ind. Hub, Poman, Kaman-Bhiwandi Road, Taluka -Vasai, Palghar- 401208,
Maharashtra (India). Customer Care No.: 8425982321. Email: [email protected]; Website:www.lordsmed.com
 LordsMed HBsAg Rapid Test
(Wholeblood/Serum/Plasma)

TEST INTERPRETATION (REFER TO FIGURE) 4. If the test result is negative and clinical symptoms
NEGATIVE RESULT: One distinct purplish pink coloured persist, additional testing using other clinical methods is
line appeared in control line ‘C’. The result is negative or recommended. A negative result does not at anytime rule
non-reactive. out the presence of HBsAg in blood, as HBsAg may be
present below the minimum detection level of the test.

BIBLIOGRAPHY
1. Emanuel Rubin and John Farber. The liver and biliary
POSITIVE RESULT: Two distinct purplish pink coloured line system. Acute viral hepatitis P 721-729. Rubin E, Farber JL
appeared in both the Control line ‘C’ and the Test line ‘T’. ed. Pathology 2nd ed.1994. J.B. Lippincott, Philadelphia.
The result is positive or reactive. 2. Kaplan PM, Greenman RL, Gerin JL, Purcell RH, Robinson
WS. DNA polymerase associated with human hepatitis B
antigen. J Virol. 1973 12(5):995-1005.
3. Dane DS, Cameron CH, Briggs M. Virus-like particles in
serum of patients with Australia-antigen-associated
hepatitis. Lancet. 1970;1(7649):695-8.
INVALID:
4. Magnius LO, Espmark A. A new antigen complex co-
• No purplish pink colour line appears in ‘C’ region
occurring with Australia antigen. ActaPathol Microbiol
and line appear only in ‘T’ region Scand [B] MicrobiolImmunol. 1972;80(2):335-7.

• No purplish pink colour line appears in ‘C’ region Catalog No Attention Caution
and ‘T’ region

Batch No. Instruction for use

PERFORMANCE CHARACTERISTICS Manufacturing In-vitro

As per National Institute of Biologicals – Noida, (NIB) the Date Diagnostics
sensitivity is 100% and specificity is 100%
AS PER NABL LAB SENSITIVITY & SPECIFICITY
Storage
Positive Negative Expiry Date
temperature
Rate
sample sample
Positive 100%
34 00
sample (Sensitivity) Manufacturer No. of Tests
Negative 100%
00 20 IFU/HBS/01 Rev No.: 01 Dated.:15/07/2024
sample (Specificity)
100%
Total 34 20 (Total
accuracy)

LMITATION
1. The Assay Procedure and the Interpretation of Assay
Result sections must be followed closely. Failure to follow
the procedure may give inaccurate results.
2. LINEAR HBsAg is a screening test. This screening test
should be used for the detection of HBsAg in serum or
plasma specimen. Neither the quantitative value nor the
rate of HbsAg concentration can be determined by this
qualitative test.
3. A non-reactive test result does not preclude the
possibility of exposure to or infection with HBV.

Lord's Mark Industries Ltd., Plot No. A71, Royal Ind. Hub, Poman, Kaman-Bhiwandi Road, Taluka -Vasai, Palghar- 401208,
Maharashtra (India). Customer Care No.: 8425982321. Email: [email protected]; Website:www.lordsmed.com