New -15% HIV (p24) Antigen Home Test

HIV (p24) Antigen Home Test Cassette

screening to detect p24 antigen to HIV type 1 only 3 to 6 weeks post exposure


  • WHO confirmed for home HIV testing.
  • Window period 3 to 6 weeks post exposure
  • Sensitivity 99.9% – Specificity 99.9%
  • Easy to use, detailed instruction manual.
  • Fast visible result in 20 minutes.
  • Discreet and anonymous shipping.
  • 24 / 7 Online Support


HIV and Aids

HIV is a virus that is usually transmitted through unprotected sexual intercourse. So by not having unprotected sex can you protect yourself against HIV. There is no cure for HIV but there are medications that slow the disease. Without HIV medications lead sooner or later to other diseases. The condition is usually called AIDS.

No symptoms.

The most common is to not get any symptoms associated with that you get HIV. How long it then takes until you feel that you have HIV varies from person to person, but it could be several years. During that time usually feel as usual and did not notice anything of the infection.

Early Symptoms

Approximately two to three weeks after getting HIV get some so-called primary HIV infection. Then you can for example get

  •     fever
  •     sore throat
  •     swollen, tender lymph nodes
  •     diarrhea
  •     muscle
  •     headache
  •     bright red, irregular rash on his back and chest, and sometimes the face, arms and legs.
  •     The early symptoms disappear by themselves, usually within a few weeks.


How long it then takes until you notice something more varies from person to person, but it could be several years. During that time usually feel as normal.

Late Symptoms

After a long period of time, usually several years, you get the first signs that your immune system is weakened. It may prove that

  •     fatigue
  •     night sweats
  •     shingles
  •     dandruff Eczema on Face
  •     fungus in the mouth.


If the immune system becomes even more impaired you can get tumors or severe infections with bacteria, fungi or parasites. This type of infection is rare in people who have a healthy immune system. It is the condition known as AIDS.

HIV (p24) 5th Generation blood sample self-test (+ all sub types)

screening tests for hiv1 + all Sub Types: (A,B,C,D,E,F,G,H and O) 3 to 6 weeks post exposure

 

HIV P24 %th Generation Test

A rapid test for the diagnosis of Human Immunodeficiency Virus to detect p24 antigen to HIV type 1 qualitatively in Whole Blood Sample. For Home in vitro diagnostic use only.

 

Intended Use

The HIV p24 Antigen Rapid Test Cassette (Whole Blood Sample) is a rapid chromatographic immunoassay for the qualitative detection of p24 antigen to Human Immunodeficiency Virus(HIV) type 1 in whole blood, serum or plasma to aid in the diagnosis of HIV infection

 

Summary

The HIV p24 antigen is a small piece of protein that is found on the capsule of the HIV virus. When a person is infected with HIV, these bits of protein can be found floating in the blood. The HIV p24 antigen rapid test is the test that detects these bits of protein. This test was first developed as a HIV screening test but rapidly ran out of favor due to the development of more advanced NAAT tests1.

 

The window period for p24 testing is also very small. This test alone is only accurate for between 3 and 6 weeks post exposure. So it is a test with very limited applications unless combined with HIV 4th Generation antigen test. The presence of p24 antigen in the blood indicated a recent HIV infection.

 

The HIV p24 Antigen Rapid Test Cassette (Whole Blood Sample) is a rapid test to qualitatively detect the presence of p24 antigen to HIV 1 in whole blood, serum or plasma specimen. The test utilizes latex conjugate HIV p24 antibody to selectively detect p24 antigen to the HIV type 1 in whole blood sample.

 

Priciple

The HIV p24 Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of p24 antigen to HIV type 1 in whole blood, serum or plasma. The membrane is pre-coated with mouse anti-HIV p24 antibody. During testing, the whole blood, serum or plasma specimen reacts with HIV p24 antibody coated particles in the test Cassette.

 

The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with HIV p24 antibody on the membrane in the test line region.  If the specimen contains p24 antigen to HIV type 1, a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain p24 antigen to HIV type 1, a colored line will not appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

 

Reagents

The test contains HIV type 1 p24 antibody coated particles and mouse anti-HIV p24 antibody coated on the membrane

 

Quality Controll

A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

 

Control standards are not supplied with this test Cassette; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance

 

Limitations

The HIV p24 Antigen Rapid Test Cassette (Whole Blood sample) is for in vitro diagnostic use only. The test should be used for the detection of HIV p24 antigen in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in HIV p24 antigen can be determined by this qualitative test.

 

The HIV p24 Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of p24 antigen to HIV type 1 in the specimen and should not be used as the sole criteria for the diagnosis of HIV infection

 

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.

 

Preformace Characteristics

 

Sensitivity and Specificity

TheHIV p24 Antigen Rapid Test Cassette (Whole Blood Sample) has been compared to a leading commercial ELISA HIV test using clinical specimens. The results show that the relative sensitivity of the HIV p24 Antigen Rapid Test Cassette (Whole Blood Sample) is 96.7% and the relative specificity is 99.3%.

 


Relative sensitivity: 96.7% (95%CI*: 82.8%~99.9%);    
Relative specificity: 99.3% (95%CI*: 97.6%~99.9%);
Accuracy: 99.1% (95%CI*: 97.4%~99.8%).     

 

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 the HIV p24 Rapid Test Cassette (Whole Blood sample) 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

The HIV p24 Rapid Test Cassette (Whole Blood sample) 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.

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HIV (p24) Antigen Home Test

Approved for home use!

used by World Health Organization: WHO

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