ASPEN HIV 1/2 Test Kit

Manufactured in India

Results in 10 mins

Clinical Sensitivity: 100%

Specificity: 99.8%

Cert: ISO 13485

Aspen Laboratories Pvt Ltd, India

Manufacturer: RAPID DIAGNOSTICS

Aims to provide quality products and the highest level of service for diagnostics segments. Through innovation and total commitment Aspen strive to create value for its customers

Through a combination of sustained, organic growth and an acquisition-led strategy, the company has assembled an impressive product portfolio and achieved the highest standards of excellence in marketing diagnostic products in Indian market.

ASPEN HIV 1/2 Test Kit

HIV 1/2 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus(HIV-1, HIV-2) type 1,type 2 in whole blood, serum or plasma to aid in the diagnosis of HIV infection.

Packaging included: 1 Aspen HIV Test Kit, 1 diluent, 1 twist lancet, 1 alcohol swab, 1 pipette

Directions For Use:

  1. Add 1 drop (25 µl) of Whole Blood to specimen well of test device using dropper/pipette.
  2. Then add 2 drop of buffer (40 µl )
  3. Read results in 10 minutes (Do not interpret the result after 20 minutes)

Interpretation of Results

POSITIVE:* Two or three distinct colored lines appear. One line should always appear in the
control line region (C), and another one or two apparent colored line(s) should appear in the
test line region(s) (T1 and/or T2).
*NOTE: The intensity of the color in the test line region (T1 and T2) will vary depending on
the concentration of HIV antibodies present in the specimen. Therefore, any shade of color in
the test line region (T1 and/or T2) should be considered positive.

NEGATIVE: One colored line appears in the control region (C). No apparent colored lines
appear in the test line regions (T1 and T2).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural
techniques are the most likely reasons for control line failure. Review the procedure and
repeat the test with a new test device. If the problem persists, discontinue using the test kit
immediately and contact your local distributor.

Clinical Sensitivity, Specificity and Accuracy

The HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) was evaluated a blood as in in-house clinical study and the in 2 specimens and an HIV Performance Panel that was purchased from a commercial source.

The HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) was compared to leading commercial ELISA HIV test and /or Western Blot.

Clinical Sensitivity: 100%

Specificity: 99.8%

Nano HIV 1 & 2 Test Kit

Certification: GMP, ISO-9001-2000

Sensitivity: 99.5%

Specificity: 99.7%

Results: 5-20 minutes

Sero diagnosis: IgG1, IgG2, IgG3, IgG4 , IgM & IgA antibodies

Principle

The NANO HIV 1 & 2 is a rapid immunochromatographic screening test for the detection of antibodies to HIV 1 & 2 in human serum, plasma or whole blood. The test device contains test strip immobilized with recombinant antigens of HIV1 at test line (1), HIV 2 recombinant antigen at test line (2) and control line reagent at (C) on nitrocellulose membrane and dried gold conjugate sensitized with HIV antigens and anti control line.

The specimen is applied to the sample well followed by addition of running buffer. The buffer facilitates the lateral flow of the sample and gold conjugate as well as promoting the immunologic binding of antibodies and antigen, if present in patient’s specimen. The HIV antibodies present in the patient’s specimen binds to the gold conjugate and make a immune complex. The complex migrates on the nitrocellulose membrane and is captured by the antigens immobilized in the Test line zone (1 & 2) and produces pink/purple band with varying intensity, proportional to the HIV 1& 2 antibodies in the sample. In the absence of HIV 1/2 antibodies, there is no pink/purple band in the TEST line zone (1&2). The liquid continues to migrate along the membrane and produces another pink/purple band in the CONTROL line zone (C), demonstrating that the reagents are functioning properly and validates the result.

Immobilization of proteins on nitro cellulose membrane

  • GP-41, GP 120 & p24 on test line 1 for capturing of HIV-1 antibodies.
  • GP-36 on test line 2 for capturing of HIV-2 antibodies.

Packaging include: 1 feather blood lancet, 1 alcohol swab, 1 pipette, 1 Nano HIV 1/2 Test Kit, 1 package insert, 1 clear plastic glove,

Test Procedure

  • Allow the kit components & test specimen to come at room temperature if stored in refrigerator.
  • Remove as many as test devices required for the testing from pouch by tearing along notch provided.
  • Lay down the test device on flat surface and mention patient’s ID number.
  • Dispense one drop (20µl) of serum, plasma or whole blood using provided dropper or micro pipette into sample well (S).
  • Add 2-3 drops of running buffer using provided dropper bottle or dropper into sample well (S).
  • Read the result in result window within 5-20 minutes of specimen and running buffer addition.

Note: Used test devices, droppers, gloves, blood / serum collection tubes, swab, lancets etc. should be discarded as per norms of Biomedical waste management.

Interpretation

Positive: The appearance of pink/purple line at ‘1’ in addition to control line at ‘C’ indicates that specimen contains antibodies of HIV-1. The appearance of test line at ‘2’ in addition to control line at ‘C’ indicates that specimen contains antibodies of HIV-2. The appearance of test line at ‘1’ & ‘2’ in addition to control line at ‘C’ indicates that specimen contains antibodies of HIV-1 & 2. The intensity of lines at ‘1’, ‘2’ and ‘C’ may vary with each other.

Negative: The appearance of no pink/purple lines at ‘1’ & ‘2’ and only one pink/purple line at ‘C’ indicates that specimen does not contain antibodies of HIV 1 & 2 and specimen should be considered negative. A negative result after 20 minutes of incubation indicates that there is no detectable level of antibodies in patient’s specimen.

Invalid: If there is no distinct pink/purple line visible at ‘C’, the test is invalid and it is recommended to repeat the test again.

 

 

 

Company’s manufacturing facility in Amritsar – Punjab.

Certification: GMP, ISO-9001-2000

Alere Determine HIV 1/2 Test Kit (WHO Certified)

Alere has a 3rd generation rapid HIV test, 3rd generation meaning it only detects antibodies. Here are the information:

Intended use:
Alere Determine® HIV-1/2 is an in vitro, visually read, qualitative immunoassay for the
detection of antibodies to HIV-1 and HIV-2 in human serum, plasma or whole blood. The
test is intended as an aid to detect antibodies to HIV-1/HIV-2 from infected individuals.

By detecting all known subtypes of HIV, Alere Determine™ HIV-1/2 will help healthcare workers across the world diagnose individual infection, prevent mother-to-child transmission, monitor HIV prevalence and screen blood donations.

With its simple one-step procedure for serum/plasma or two-step procedure for whole blood, the Alere Determine™ HIV-1/2 is quick and easy to use, delivering clear, dependable results in just 15 minutes.

Certification: WHO

Made in Japan

In this limited performance evaluation using a panel of 1079 biological specimens, we
observed aninitial (sensitivity (95% CI) of 100% (99.1% – 100%) and an initial specificity (95%
CI) of 97.87% (96.4% – 98.8%) compared to the reference assays. The final sensitivity (95% CI)
was 100% (99.1% – 100%) and the final specificity (95% CI) was 98.93% (97.8% – 99.6%)
compared to the reference assays. In this study, 0.3% of the overall results were recorded as
indeterminate. Results were interpreted independently by three technicians; the interreader
variability was 1.4%. The invalid rate was 0.3% for initial testing and 0.1% for repeat
testing.

Results in 15 minutes

Usage Guide

 

What’s your CD4 and Viral Load

Quick guide to test results

CD4 counts
l Between 500 and 1200 = usual for people who don’t have HIV
l Above 350 = HIV treatment isn’t usually recommended
l Below 350 = HIV treatment is recommended
lBelow 200 = there is a higher risk of illnesses and infections, so HIV treatment is recommended

Your doctor may give your CD4 results as a percentage
l Above 29% = similar to a CD4 count of above 500
l Below 14% = similar to a CD4 count of below 200

Viral load
l Between 100,000 and 1 million = high
l Below 10,000 = for people with HIV not on treatment, this is low
l Below 50 = known as an ‘undetectable’ viral load. The aim of HIV treatment
is to have an undetectable viral load.

How long should i wait before taking a herpes blood test?

 

Dear Doctor,

I have been exposed to my girlfriend who has genital herpes and now i develop rash on my penis. I have visited a clinic and they diagnosed me this rashes as fungal infection. My question is, how many weeks after my 1st outbreak should i wait to make sure i build up enough antibodies to test for blood test for Herpes test kit?

Jake

*********

Dear Jake,

Quite many doctors incorrectly diagnose herpes as jock itch, or fungal infection, ingrown hairs, frictions, or even yeast infection. For herpes, it will takes about 12-16 weeks after your first exposure to herpes in order to give the virus antibody enough time to show up in your blood stream.

If you take a blood test now, and the result is positive, then it is high possibility that you were already infected with the HSV2 virus BEFORE your encounter with this last person.

Statistics show that @ 20% of all US adults and 1 in every 4 women have the HSV-2 virus, and over 50% carry the HSV-1 virus (either orally or genitally), but most of them DON’T EVEN KNOW IT. This is because most people have mild, infrequent or even NO symptoms. And most doctors don’t routinely give blood tests for herpes even when they are testing you for other STD’s – unless you SPECIFICALLY request a herpes blood test. So most people have never been tested for herpes! Some people who become infected with herpes don’t have their first outbreak until YEARS after they were first infected. So unless you had a negative herpes blood test prior to having sex with this last person, you’ll never really know if you got herpes from HER, or someone else BEFORE her. It is possible to spread herpes even when there are no symptoms. Just think – one in every four of your previous sexual partners had genital herpes and probably didn’t know it! Safe Sex is always the best policy.

 

Herpes Blood Test Kit

Blood tests can be used when a person has no visible symptoms but has concerns about having herpes. Blood tests do not actually detect the virus; instead, they look for antibodies (the body’s immune response) in the blood.

IgM vs. IgG

When an individual contracts herpes, the immune system responds by developing antibodies to fight the virus: IgG and IgM. Blood tests can look for and detect these antibodies, as the virus itself is not in blood.

**IgG appears soon after infection and stays in the blood for life.

**IgM is actually the first antibody that appears after infection, but it may disappear thereafter.

IgM tests are not recommended because of three serious problems:

1. Many assume that if a test discovers IgM, they have recently acquired herpes. However, research shows that IgM can reappear in blood tests in up to a third of people during recurrences, while it will be negative in up to half of persons who recently acquired herpes but have culture-document first episodes. Therefore, IgM tests can lead to deceptive test results, as well as false assumptions about how and when a person actually acquired HSV. For this reason, we do not recommend using blood tests as a way to determine how long a person has had herpes. Unfortunately, most people who are diagnosed will not be able to determine how long they have had the infection.

2. In addition, IgM tests cannot accurately distinguish between HSV-1 and HSV-2 antibodies, and thus very easily provide a false positive result for HSV-2. This is important in that most of the adult population in the U.S. already has antibodies to HSV-1, the primary cause of oral herpes. A person who only has HSV-1 may receive a false positive for HSV-2.

3. IgM tests sometimes cross-react with other viruses in the same family, such as varicella zoster virus (VZV) which causes chickenpox or cytomegalovirus (CMV) which causes mono, meaning that positive results may be misleading.

The accurate herpes blood tests detect IgG antibodies. Unlike IgM, IgG antibodies can be accurately broken down to either HSV-1 or HSV-2. A recent study corroborates this finding: labs that used non-gG-based tests for herpes had high false-positive rates for HSV-2 antibodies (14-88% saying the blood sample was positive for HSV-2) in samples that were actually only positive for HSV-1 antibodies. But 100% of the labs using gG-based tests accurately reported that the blood sample was negative for HSV-2 .

The challenge here is that the time it takes for IgG antibodies to reach detectable levels can vary from person to person. For one person, it could take just a few weeks, while it could take a few months for another. So even with the accurate tests, a person could receive a false negative if the test is taken too soon after contracting the virus. For the most accurate test result, it is recommended to wait 12 – 16 weeks from the last possible date of exposure before getting an accurate, type-specific blood test in order to allow enough time for antibodies to reach detectable levels.