Month: October 2017

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%

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 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