HIV(1+2) Antibody Rapid Test Kit
For qualitative detection of HIV(1+2) antibodies in serum/plasma
and whole blood
Main Features
1. Sensitivity: 100%
2. Specificity: Higher than 99%
3. Reliable: able to differentiate HIV Type I and Type II
4. Certified by Authoritative Certification
5. Unique 3-line Patented Design
6. Simple: No Instrument Required
7. Ambient Storage
Intended Use
Newscen HIV(1+2) Antibody Rapid Test is a single use, rapid
immunoassay for qualitative detection of antibodies to Human
Immunodeficiency Virus type 1 and 2 (HIV-1/2) in human serum,
plasma or whole blood collected from vein or fingertip. It is
intended for use in medical institutions by trained staff.
Reagents and Materials Provided
Each kit contains:
1.40 test cassettes(individually pouched)
2.Each pouch contains one cassette with one desiccant bag
3.One bottle of diluent buffer(5ml)
4.40 disposable plastic droppers
5.Instruction for use
Materials Required But Not Provided
1.Timer or stopwatch
2.Blood collection devices, for the testing of venous whole blood,
serum or plasma
3.Biohazard disposal container
4.Disposable gloves
For finger stick samples, the following materials are required:
1. Alcohol pad
2. Sterile lancet
3. Sterile gauze or cotton
Storage
Newscen HIV(1+2) Antibody Rapid Test should be stored at room
temperature (4-30℃, do not freeze) for 24 months from the date of
manufacture.
Keep the test cassette in sealed pouch until use. Once you have
taken the test cassette out of the pouch, perform the test as early
as possible(within 1hour) to avoid test cassette from becoming
moist. Do not use the test beyond the indicated expiration date.
The diluent buffer should be stored at room temperature(4-30℃, do
not freeze) .
Warning
For Invitro Diagnostic Use ONLY
Read the package insert completely before use. It is very important
that the correct procedure is followed. Fail to add the patient
sample may lead to a false negative result (i.e.a missed positive)
Sample Collection and Test Preparation
Finger stick Specimens(Whole Blood)
1.Clean the area to be lanced with an alcohol pad.
2.Squeeze the end of the fingertip and pierce it with a sterile
lancet.
3.Wipe away the first drop of blood with sterile gauze or cotton;
collect the sample from the second drop.
4.Use dropper to obtain appropriate amount of fresh blood and
dispense into the sample well.
Finger stick whole blood should be used immediately after
collection.
Serum/Plasma specimens:fresh serum or plasma specimen can be used.
No special patient preparation required.
Plasma
1.Collect whole blood into a collection tube(containing EDTA,
Na-citrate or heparin) by venipuncture.
2.Separate the plasma by centrifugation.
Serum
1.Collect whole blood into a collection tube(containing no
anticoagulants) by venipuncture.
2.Allow the blood to clot.
3.Separate the serum by centrifugation.
Any visible particulate matter in the specimen should be removed by
centrifugation or filtration. Avoid using of hemolytic, turbid,
microorganism contaminated specimens or specimens stored for over 5
days at 4°C.Specimen should be stored frozen at-20°C for maximum 3
months. Avoid specimen deterioration by multiple freeze-thaw
cycles.
Venous Whole Bloods
Venous whole blood can be used immediately after collection or
stored up to 4 days at 2-8°C.
Assay Procedure
1.Place the test cassette on flat surface. Before unseal the pouch,
allow the test cassette to reach room temperature(4-30°C) .Use it
immediately once unsealed.
2.Open the pouch and add1drop(30-40uL) of specimen into the sample
well(S) .
3.When the specimen is completely absorbed, slowly
add1drop(45-55pL) of diluent buffer vertically into the sample
well(s) .
4.Avoid dropping specimen or diluent buffer in the observation
window.
5.Do not allow the diluent buffer bottle touch the sample well when
dropping the diluent buffer so as to prevent the cross
contamination with the specimen.
6.Observe the result between 15-30 minutes after the diluent buffer
added.
Built-In Control
Newscen HIV(1+2) Antibody Rapid Test has a built-in procedural
control that demonstrates assay validity. A redline appeared on the
control zone(C) indicates that the test runs correctly.
