Accu-Tell^® HIV 1/2 Rapid Test Cassette (Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: Antibodies to HIV type 1 and type 2 in Serum or plasma;

Specimen volume: Serum or Plasma Specimen: 25μL;

Reading time: 10 minutes;

Relative sensitivity: >99.99% (97.5%CI*: 97.20%~100.0%);  

Relative specificity: 99.88% (95%CI*: 99.57%~99.99%);

Accuracy: 99.89% (95%CI*: 99.60%~99.99%).      

INTRODUCTION

HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from host cell membrane. Several viral glycoproteins are on the envelope. Each virus contains two copies of positive-sense genomic RNAs. HIV 1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy people with high potential risk for developing AIDS.1 HIV 2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals. Both HIV 1 and HIV 2 elicit immune response. Detection of HIV antibodies in serum, plasma is the most efficient and common way to determine whether an individual has been exposed to HIV and to screen blood and blood products for HIV.

INTENDED USE

ACCU-TELL^® HIV 1/2 Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) type 1 and type 2 in serum or plasma to aid in the diagnosis of HIV infection.

TEST PROCEDURE

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.

2.  Place the cassette on a clean and level surface.

For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25μL) to the specimen area, then add 1 drop of buffer (approximately 40μL),and start the timer.

3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL^® HIV 1/2 Rapid Test Cassette (Serum/Plasma) has correctly identified specimens of a seroconversion panel and has been compared to a leading commercial ELISA HIV test using clinical specimens. The results show that the relative sensitivity of ACCU-TELL^® HIV 1/2 Rapid Test Cassette (Serum/Plasma) is >99.99% and the relative specificity is 99.88%.

Relative sensitivity: >99.99% (97.5%CI*: 97.20%~100.0%);  

Relative specificity: 99.88% (95%CI*: 99.57%~99.99%);

Accuracy: 99.89% (95%CI*: 99.60%~99.99%).      

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of four specimens: a negative, a low positive, a medium positive and a high positive. The negative, low positive, medium positive and high positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 15 independent assays on the same four specimens: a negative, a low positive, a medium positive and a high positive. Three different lots of ACCU-TELL^® HIV 1/2 Rapid Test Cassette (Serum/Plasma) have been tested over a 3-day period using negative, low positive, medium positive and high positive specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL^® HIV 1/2 Rapid Test Cassette (Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV, Syphilis, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following potentially interfering substances were added to HIV negative and positive specimens.

Acetaminophen:       20 mg/dL           Caffeine:         20 mg/dL

Acetylsalicylic Acid:  20 mg/dL           Gentisic Acid: 20 mg/dL

Ascorbic Acid:                2g/dL            Albumin:              2 g/dL

Creatin:                   200 mg/dL           Hemoglobin:   1.1 mg/dL

Bilirubin:                         1g/dL           Oxalic Acid:     600mg/dL

None of the substances at the concentration tested interfered in the assay.

LIMITATIONS

1. ACCU-TELL^® HIV 1/2 Rapid Test Cassette (Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of HIV antibodies in serum or plasma specimens only. Neither the quantitative value nor the rate of increase in HIV antibodies can be determined by this qualitative test.

2. ACCU-TELL^® HIV 1/2 Rapid Test Cassette (Serum/Plasma) will only indicate the presence of HIV antibodies in the specimen and should not be used as the sole criteria for the diagnosis of HIV infection.

3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of HIV infection.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.