One step HIV blood test kit

One step HIV blood test kit
Product details
One Step HIV1/2 Whole Blood/Serum/Plasma Test(2 lines)
INTENDED USE
One Step HIV1/2 Whole Blood/Serum/Plasma Test (2 lines) is intended for use by healthcare professionals and as qualitative screening diagnostic test for detection of HIV-1 (including group M, group N and group O) and HIV-2 antibodies in human whole blood, serum or plasma at specified cut-off level. This test is not automated and does not require any additional instrument.
SUMMARY
HIV (human immunodeficiency virus) is the pathogen of AIDS (acquired immunodeficiency syndrome). HIV belongs to Retroviridae family Lentivirus genus. There are two groups, HIV-1 and HIV-2.
HIV-1 is highly mutagenous, and can be divided into 3 groups by the mutations in its membrane protein, which are group M, group N and group O. HIV-2 has 60% nucleotide acid homology with HIV-1, but they are different in their ability of infection, HIV-1 is the most prevailing virus strain. once infected, it mutates quickly and has bad prognosis. HIV-2 has a longer latent period and relatively weaker pathogenesis.
PRINCIPLE
One Step HIV1/2 Whole Blood/Serum/Plasma Test (2 lines) is a rapid immunochromatographic test for visual detection of HIV-1 (including group M, group N and group O) and HIV-2 antibodies in whole blood, serum or plasma samples in the diagnosis of HIV infection. This test cassette uses double antigen sandwich method.
When the specimen is added into the test device, it is absorbed into the device by capillary action, mixes with the antigen-dye conjugate, and flows across the pre-coated membrane.
When the HIV antibody level in the specimen is at or above the detection limit of the test, HIV antibodies bound to the antigen-dye conjugate are captured by antigen immobilized in the test region (T) of the device. This produces a colored test band, which indicates a positive result.
When the HIV antibody level in the specimen is zero or below the detection limit of the test, there is not a visible colored band in the test region (T) of the device. This indicates a negative result.
To serve as a procedure control, a colored line will appear at the control region (C), if the test has been performed properly.
PRECAUTIONS
1. This kit is for use only. Do not swallow.
2. All specimens should be treated as biohazards.
3.Icteric,lipaemic,hemolytic,heat-treated and contaminated blood may cause erroneous results.
3. Discard the test after use. Each test cannot be used more than once.
4. Do not use test kit beyond the expiration date.
5. Do not use the kit if the pouch is punctured or not well sealed.
6. Keep out of the reach of children.
7. All specimens and used-devices have infectious risks. The disposal process must follow the local infectious disposal law or laboratory rule.
MATERIALS
MATERIALS PROVIDED
1. Individual sealed pouches, each contains:
1 x Test cassette
1 x Dropper
1 x Desiccant pouch
(The desiccant is for storage purposes only, and is not used in the test procedures)
2. Buffer (5 mL/bottle): 0.02M Tris
3. Leaflet with instructions for use
MATERIALS REQUIRED BUT NOT PROVIDED
1. Alcohol pads
2. Lancets
3. Timer
One Step HIV1/2
STORAGE AND STABILITY
1. The test devices should be stored at 4ºC~30ºC.
2. The unopened test devices are stable until the expiration date printed on the package.
3. Keep away from sunlight, moisture and heat.
4. DO NOT FREEZE.
PECIMEN COLLECTION AND PREPARATION
Whole blood collected by fingerstick:
1. Select the finger for puncture, usually the side of the fourth finger. Clean the area to be lanced with an alcohol pad. Allow the finger to dry thoroughly.
2. Using a sterile lancet, puncture the skin just off the centre of the finger pad. Hold the finger downward. Apply gentle pressure beside the point of the puncture. Avoid squeezing the finger to make it bleed. Wipe away the first drop of blood with a sterile swab. Allow a new drop of blood to form. If blood flow is inadequate, the subject’s finger may have to be gently massaged at the finger base to produce a droplet of sufficient volume. Avoid ‘milking’ the finger.
3. Take a sample dropper provided, while gently squeezing the tube, immerse the open end in the blood drop and then gently release the pressure to draw blood into the dropper. Whole blood samples collected by fingerstick should be used immediately after collection.
Whole blood collected by venipuncture:
1. Using standard phlebotomy procedure, collect a venipuncture whole blood specimen using a blood collection tube with suitable anticoagulant
2. It is recommended that specimens should be tested immediately. Do not leave the specimens at room temperature for prolonged periods. If the specimens are not tested immediately, they could be stored at 2°C~8°C.
It’s not suitable to test the whole blood samples which have been stored at 2°C~8°C for more than 7 days.
Serum and Plasma:
1. Using standard phlebotomy procedure, collect a venipuncture whole blood specimen using a blood collection tube. If you need plasma sample, please use a blood collection tube containing suitable anticoagulant.
2. Separate the serum/plasma from blood as soon as possible to avoid hemolysis.
3. Test should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Specimens could be stored at 2°C~8°C for up to 3 days. For long-term storage, specimens should be kept below -20°C.
Bring specimens to room temperature before testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly. only clear, non-hemolytic specimens can be used.
TEST PROCEDURE
Allow the device, buffer and specimen to equilibrate to room temperature (10°C~30°C) prior to testing.
1. Remove a test cassette from the foil pouch by tearing at the notch and place it on a level surface.
2. Slowly add 10 µL (the second tick mark line) of whole blood or serum or plasma into the sample well (A) and then add 2 drops of dilution buffer to the buffer well (B).
3. As the test begins to work, you will see purple color move across the result window into the center of the test device.
4. Wait for 15 minutes and read the results. Do not read results after 30 minutes.
INTERPRETATION OF RESULTS
Positive (+)
Rose-pink bands are visible in both the control region and the test region. A positive result indicates presence of HIV1/2 antibodies is equal to or higher than the detection limit of the test.
Negative (-)
A rose-pink band is visible in the control region. No color band appears in the test region. It indicates that the concentration of the HIV1/2 antibodies is zero or below the detection limit of the test.
Invalid
No visible band at all, or there is a visible band only in the test region but not in the control region. Repeat with a new test kit. If test still fails, please contact the distributor or the store, where you bought the product, with the lot number.
Whole Blood/Serum/Plasma Test
Note: There is no meaning with line color intensity or width.
QUALITY CONTROL
Though there is an internal procedural control line in the control region of test device, the use of external controls is strongly recommended as good laboratory testing practice to confirm the test procedure and to verify proper test performance. Positive and negative controls should give the expected results. When testing the positive and negative controls, the same assay procedure should be adopted.
One Step HIV1/2
Whole Blood/Serum/Plasma Test(2 lines)
Product show:
Packaging & Shipping
Sample time7-15 days Production time20-30 days after the advance paymentPackingEach test in one foil pohch,50pcs/polybag,1000pcs/carton, or custom packingLoading portChina main port, such as Beijing,Tianjin,ShanghaiShipping
By air,sea or combined transportation.
Express:Fedex,TNT,UPS,DHLPrice TermsEXW,FOB,CNF & CIFPayment Terms
1. 100% by T/T in advance when total amount is less than USD1000;
2. By T/T,50% in advance after you confirm the order and 50% balance payable before shipment;
3. West Union;
4, Paypal
Company Information
Trade Shows
Contact us
H.Y.T Medical(Beijing) Co.,LtdCONTACT: VayneTEL: +86-10-80598795
Wechat / Whatsapp: +86 15859295062EMAIL: vayne(@)hytmedical.com.cnWEB: www.hytmedical.com.cn