FAMKA STD-HERPES Antibody Rapid Test Cassette Instruction Manual

: June 5, 2024
: FAMKA

Table of Contents

FAMKA STD-HERPES Antibody Rapid Test Cassette
INTENDED USE
PRINCIPLE
PRECAUTIONS
STORAGE AND STABILITY
SPECIMENS COLLECTION
ASSAY PROCEDURE
INTERPRETATION OF RESULTS NEGATIVE RESULTS:
LIMITATION
References
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FAMKA STD-HERPES Antibody Rapid Test Cassette

INTENDED USE

The kit is an IVD rapid test for the qualitative detection of HSV 1/11 lgG/LGM antibodies in human whole blood, serum, or plasma specimen

PRINCIPLE

The HSV 1/11 lgG/LGM Antibody Rapid Test Cassette (Colloidal Gold) is a qualitative membrane stripbased immunoassay for the detection of HSV 1/11 antibodies (lgG and LGM) in Serum/Plasma and whole blood. The test device consists of 1)a burgundy-colored conjugate pad containing HSV 1/11 recombinant envelope antigens conjugated with Colloid gold (HSV conjugates),2)a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with Mouse anti-human LGM monoclonal antibody for the detection of HSV 1/11 LGM Antibody, T2 band is coated with Mouse anti-human lgG monoclonal antibody for the detection of HSV 1/11 LG Antibody, and the C band is pre-coated with Mouse Mouse anti-HSV antibody, When an adequate volume of the test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette.LGM anti– HSV I/ II, if present in the specimen, will bind to the HSV 1/11 recombinant envelope antigens conjugates. The immunocomplex is then captured by the reagent pre-coated on the ! 1 band. forming a burgundy colored T1 band indicating an HSV 1/11 LGM positive test result and suggesting a recent or repeat infection. lgG anti- HSV I/ II if present in the specimen will bind to the HSV 1/11 recombinant antigens conjugates. The immunocomplex is then captured by the reagent coated on the T2 band, forming a burgundy colored T2 band, indicating an HSV 1/11 LG positive test result and suggesting a Previous infection. Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of Mouse anti-HSV antibody/ HSV 1/11 recombinant antigens gold conjugate regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.

COMPONENTS MATERIALS PROVIDED

HSV 1/11 lgG/LGM Antibody Rapid Test Cassette (Colloidal Gold)
Assay buffer
Lancet
Alcohol Wipe
Pipette
Package Insert

MATERIALS NOT PROVIDED BUT REQUIRED

Timer

PRECAUTIONS

For professional in vitro diagnostic use only.
Do not use it after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged.
Do not reuse tests.
Avoid cross-contamination of specimens by using a new specimen container for each specimen obtained.
Read the entire procedure carefully prior to testing.
Do not interchange or mix reagents from different lots.
Humidity and temperature can adversely affect results.
Used Testing materials should be discarded according to local regulations.

STORAGE AND STABILITY

The kit should be stored at 2-30°( until the expiry date is printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Do not freeze.
Cares should be taken to protect components in this kit from contamination.
Do not use it if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers, or
reagents can lead to false.

SPECIMENS COLLECTION

Whole Blood

Whole blood can be used for tests immediately.
Serum and Plasma
Plasma samples can be treated with heparin, sodium citrate, and EDTA. Serum or plasma samples can be stored at 2-8 ° C for 8 days, at least 3 months
below -18 ° C.
Do not repeat freezing and thawing. If there’s turbidity and sediment in the sample, centrifuge it first. Take the clear liquid for testing.

ASSAY PROCEDURE

Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
When ready to test, open the pouch at the notch and remove the device. Place the test device on a clean, flat surface.
Be sure to label the device with the specimen’s ID number.
Add 1 drop (30 μL) of whole blood/ serum/ plasma into the sample well, making sure that there are no air bubbles. Then add 2 drops (about 60-70 μL) of assay buffer immediately.
Set up a timer.
Results can be read in 20 minutes. Don’t read the result after 20 minutes. To avoid confusion, discard the
test devise after interpreting the result.

INTERPRETATION OF RESULTS NEGATIVE RESULTS:

If only the C band is present, the absence of any burgundy color in both T bands (T1 and T2) indicates that no HSV 1/11 lgG/LGM antibodies are
detected in the specimen.
POSITIVE RESULT:
In addition to the presence of the C band, if only the T1 band is developed, the test indicates the presence of the HSV 1/11 LGM antibody. The result
is positive.
In addition to the presence of the C band, if only the T2 band is developed, the test indicates the presence of HSV 1/11 lgG. The result is positive.
In addition to the presence of the C band, both T1 and T2 bands are developed, and the test indicates
the presence of HSV 1/11 lgG and LGM. The result is also positive.
Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a positive determination is made.
INVALID:
If no C band is developed, the assay is invalid regardless of any burgundy color in the test bands as indicated below. Repeat the assay with a new device.

LIMITATION

The Assay Procedure and the Test Result Interpretation must be followed closely when testing the presence of antibodies to Herpes simplex virus lgG/LGM Antibody in serum, plasma, or whole blood from individual subjects. Failure to follow the procedure may give inaccurate results.
The HSV 1/11 lgG/LGM Antibody Rapid Test Cassette (Colloidal Gold) is limited to the qualitative detection of antibodies to HSV 1/11 antibody in human serum, plasma, or whole blood. The intensity of the test band does not have a linear correlation with the antibody titer in the specimen.
A negative result for an individual subject indicates the absence of detectable HSV 1/11 antibodies. However, a negative test result does not preclude the possibility of exposure to HSV 1/11 antibody.