Accu-Tell^® HIV Ag/Ab Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: Antibodies to HIV type 1, type 2, Subtype O and antigens to HIV P24 qualitatively in whole blood, Serum or plasma.

Specimen volume: Serum or Plasma specimen: 25μL;

                                 Venipuncture or Fingerstick Whole Blood specimen: 50μL;

Reading time: 10 minutes;

Relative sensitivity: >99.9% (95%CI*: 99.3%~100.0%);  

Relative specificity: 99.5% (95%CI*: 99.0%~99.8%);

Accuracy: 99.6% (95%CI*: 99.2%~99.8%).        

INTRODUCTION

HIV (Human Immunodeficiency Virus) is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from the host cell membrane. Several viral glycoproteins are on the envelope. During HIV infection, the p24 antigen is produced during the first few weeks and is detectable 7-9 days earlier than the appearance of HIV antibodies. As a result, the p24 antigen is an ideal marker in aiding early HIV diagnosis. 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. HIV-1 consists of Subtype M and Subtype O.

INTENDED USE

ACCU-TELL^® HIV Ag/Ab Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus(HIV) type 1,type 2 and subtype O and antigens to Human Immunodeficiency Virus(HIV) P24 in whole blood, 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, see illustration below.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μL) to the specimen area, then add 2 drops of buffer (approximately 80μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 50μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 2 drops of buffer (approximately 80μL) and start the timer. See illustration below.

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 Ag/Ab Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) has correctly identified specimens of 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 Ag/Ab Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is >99.9%, and the relative specificity is 99.9%.

Relative sensitivity: >99.9% (95%CI*: 99.3%~100.0%);  

Relative specificity: 99.5% (95%CI*: 99.0%~99.8%);

Accuracy: 99.6% (95%CI*: 99.2%~99.8%).      

*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 Ag/Ab Combo Rapid Test Cassette (Whole Blood/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 Ag/Ab Combo Rapid Test Cassette (Whole Blood/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.

Interference studies

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:              20mg/dL                                Albumin:                      2 g/dL

Creatin:                     200 mg/dL                                Hemoglobin               1.1g/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 Ag/Ab Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of HIV antibodies or antigens in whole blood, 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 Ag/Ab Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of HIV antibodies or antigens in the specimen and should not be used as the sole criteria for the diagnosis of HIV infection.

3. For confirmation, further analysis of the specimens should be performed according to local health authorities’ guidelines, such as ELISA and/or Western Blot analysis.

4. As with all rapid test cassettes, all results must be interpreted together with other clinical information available to the physician.

5. This test is intended for screening purposes only. Results should not be used to determine the serotype of HIV infections. 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.