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- Product Detail
- For in vitro diagnostic uses only.
- Clean up spills thoroughly using an appropriate disinfectant.
- Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they were infectious waste, in a biohazard container.
- Do not mix and interchange different specimen.
- Anticoagulants such as heparin, EDTA and sodium citrate do not affect the test result.
- Lcteric, lipemic, hemolysed, heat treated and contaminated specimens may give erroneous results.
- Do not use test kit beyond expiration date.
- Forty pouched cassettes with desiccant and dropper.
- Blood diluent in a dropper bottle, stored at 2-8°C.
- One piece of operating instruction.
- Specimen collection container, either plastic or class.
- Timer.
- Disposable gloves.
- Clean the area to be lanced with an alcohol swab.
- Squeeze the end of the fingertip and pierce it with a sterile lancet.
- Wipe away the first drop of blood with sterile gauze or cotton.
- Use micropipet to obtain about 100ul fresh blood .
- Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
- Separate the plasma by centrifugation.
- Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.
- Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.
- Allow the blood to clot.
- Separate the serum by centrifugation.
- Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.
- A negative result does not rule out infection by HIV because the antibodies to HIV may be absent or may not be present in sufficient quality to be detected at early stage of infection.
- A positive result, even a weak positive, must be verified with a confirmation test.
- As with all diagnostic tests, the result must be correlated with clinical findings. If the test result is negative and suspicion still exists, additional follow-up testing using other clinical methods is recommended.
- Always best of all and always pay attention to innovation.
- Special customized service tightly following customers’ requests.
- Integrated excellent quality, competitive prices and super service together.
HIV(1+2) Ag/Ab Combo Test Kit (3 lines)
Cat. No.: RH0210I
INTRODUCTION
The HIV (1+2) Ag/Ab combo rapid test kit is a rapid, qualitative test for the detection of HIV p24 antigen and antibodies to all isotypes (IgG, IgM and IgA) specific to HIV-1 including subtype-O and/or HIV-2 simultaneously in human serum, plasma or whole blood. The antigens are prepared with proteins to have HIV-1, gp41, gp120 and gp36. For HIV 2, p24 ab & gp36. The HIV (1+2) Ag/Ab Combo Test kit (3lines) is intended for professional use, only for an initial screening test and reactive samples should be confirmed by a supplemental assay such as ELISA or Western Blot test.
PRECAUTION
SUMMARY AND EXPLANATION OF THE TEST
HIV (Human Immunodeficiency Virus) is recognized as the etiologic agent of Acquired immune Deficiency Syndrome (AIDS). The virus is transmitted by sexual contact, exposure to infected blood, certain body fluids or tissues, and from mother to fetus or child during the perinatal period. HIV-1 has been isolated from patients with high potential risk of developing AIDS.
HIV-1 appears to be the most common one while HIV-2 is mostly found in patient samples from West African region. Its course is marked by increasing levels of viral replication and the emergence of more virulent viral strains. This process causes the destruction of the immune system. HIV infection is staged by CD4 cell counts and clinical symptoms. Not all people progress through all “stages” and the time frames may also very greatly from person to person.
PRINCIPLE
The 4th generation HIV(1+2) Ag/Ab Combo Test kit (3lines) contains a membrane strip, which is pre-coated with mouse monoclonal Anti-HIV p24 antibody on test line “2” region with gp36 and test line “1” region with recombinant HIV-1/HIV-2 antigens respectively. The mixture of mouse monoclonal anti-HIV p24 antibody and recombinant HIV-1/HIV-2 antigen-colloid gold conjugate form a visible lines (1&2) as the antigen-antibody-antigen or antibody-antigen-antibody gold particle complex with high degree of sensitivity and specificity.
The test lines and control line in the result window have been clearly labeled. For line “2” is for HIV p24 antigen and/or antibodies to HIV-2 and line “2” is for antibodies to HIV-1/HIV-2, and “C” for Control line. All the test lines and control line in the result window are not visible before applying any sample. The control line is used for procedural control and should always appear if the test procedure is performed correctly.
MATERIALS SUPPLIED
MATERIALS NOT PROVIDED BUT REQUIRED
SPECIMENS COLLECTION AND STORAGE
Fingerstick Specimens(Whole Blood)
Plasma
Serum
ASSAY PROCEDURE
Add 1 drop (1 drop = 35µl) of sample (whole blood/serum/plasma) into the sample well. After all samples completely absorbed, add 1 drop of diluent. Observe the result in 5-15 minutes.
QUALITY CONTROL
An internal procedural control is included in the test. Red line will appears in the control region (C).
INTERPRETATION OF RESULTS
Negative: No apparent band in the test region (1 and 2), Only one red band appears in the control region (C). This indicates that no HIV p24 antigen and/or antibodies to HIV-1/HIV-2 have been detected.
Positive:
1) The presence of two lines as control line “C” and test line “2” within the result window indicates a positive result for HIV p24 antigen and/or HIV-2. The presence of HIV antigen suggests that the infection is at an early stage.
2) The presence of two lines as control line “C” and test line “1” within the result window indicates a positive result for antibodies to HIV-1/HIV-2.
3）The presence of three lines as control line “C”, test line “2” and test line “1” within the result window indicates a positive result for HIV p24 antigen and/or antibodies to HIV-1/HIV-2. The presence of HIV antigen suggests that the infection is at an early stage.
Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (T1 & T2). It indicates a possible error in performing the test. The test should be repeated using a new device.
Note: Except the red line, no other color line means a positive result. Do not read the results after 30 minutes. Dispose off the used cassette as infectious material.
PERFORMANCE CHARACTERISTICS
Analytical Sensitivity
The detection limit of the HIV(1+2) Ag/Ab Combo Test kit (3lines) is 2IU/ml, which is evaluated by testing the HIV-1 p24 antigen panel from the National institute for Biological Standard and Control.
STORAGE AND STABILITY
Store the 4th generation HIV(1+2) Ag/Ab Combo Test Kit (3lines) at temperature ranges 2-30°C in the sealed pouch for the duration of the shelf life period (24months). Refer to the expiration date for stability. Do not freeze.
LIMITATION
1. The test is to be used for the qualitative detection of antibodies to HIV.
Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
Our mission:
Span Biotech Ltd.
Add: 6A, Unit 5, Building 3, Sunshine Aloha, Bantian Industrial Park, Banxuegang Road , Longgang Shenzhen 518129
Tel:+86-755-89589611
E-mail: infospanbio.com
Packaging Details:
Pouch+Box+Carton packaging
(1) With our company’s Logo
(2) With the natural package
(3) With OEM package
(4) ODM
Anna
Int'l Market Executive
SPANBIO
Tel: +86(755)89589611
Cell Phone:+8613417551798(WhatsApp)
EMAIL: annaleespanbio.com
-
Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
Efficiently structured to provide lasting and economic health care solutions with export ready goods, our main products cover the following immunodiagnostic rapid test kits:
Rapid Tests for Human Use :
1) Fertility: Pregnancy HCG, ovulation LH, menopause FSH
2) Infectious diseases: Hepatitis B, HCV, HIV
3) Drug abuse: AMP, BAR, BZO, COC, mAMP, MOP, MTD, OPI, PCP, TCA, THC
4) Tumor markers: CEA, PSA, AFP, FOB
5) STDs(Sexually Transmitted Diseases): Gonorrhea, syphilis, chlamydia
6) New products: Malaria, H. Pylori, Multi-Hepatis B Panel (HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc), Blood Glucose Test, Multi-drug of Abuse Panel, Avian (Bird) Flu Rapid Test, etc.
Rapid Tests for Veterinary :
1) Bovine: Cow Pregnancy , Cow Ovulation, Bovine Brucella, Bovine Tuberculosis ,Food and Mouth Disease NSP Ab Test
2) Canine: Canine Distemper, Canine Parvovirus, Canine Coronavirus
3) Feline : Feline Leukemia Virus Ag Rapid Test ,Feline Panleucopenia Virus Ag Test,Feline Immunodeficiency Virus Ab Test
Rapid Tests for Food Safety :
1)For Antibiotics Residue : Nitrofurans (AOZ,AMOZ, AHD, SEM), Streptomycin , Sulfonamides , Chloramphenicol , Quinolone , Beta-Lactam&Tetracycline Combo (2 in 1), β-Lactams & Streptomycin & Chloramphenicol & Tetracyclines Combo (4 in 1), Beta-Lactam, Tetracycline test
2) For Beta-Agonist Residue : Ractopamine, Clenbuterol ,Salbutamol
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