HIV 1.2.O Rapid Test Cassette 【SPECIMEN COLLECTION AND PREPARATION】 POSITIVE:* Two or three coloured lines appear.

POSITIVE:* Two or three coloured lines appear. One line should always appear in the
(Whole Blood/Serum/Plasma) control line region (C), and one or two more lines should appear in the test line region
 The HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) can be used with (T1 and/or T2) .
Instructions for use whole blood (venipuncture or fingerstick), serum or plasma. * NOTE: The intensity of the colour in the test region (T1 and/orT2) may vary depending
 To collect Fingerstick Whole Blood specimens: on the concentration of the HIV antibodies present in the specimen. Therefore, any
REF IHIV-C42 English  Wash the patient’s hand with soap and warm water or clean with an alcohol swab. shade of colour in the test region (T1 and/or T2) should be considered positive.
Allow to dry. NEGATIVE: One coloured line appears in the control region (C). No apparant lines
A rapid test for the diagnosis of human immunodeficiency virus for the qualitative detection appear in the test region (T1 and T2).
 Massage the hand without touching the puncture site by rubbing down the hand INVALID: The control line fails to appear. Insufficient specimen volume, incorrect
of antibodies against HIV type 1, type 2 and subtype O in whole blood, serum or plasma. towards the fingertip of the middle or ring finger
For in vitro diagnostic use only. operating procedure or expired tests are the most likely reasons for control band failure.
 Puncture the skin with a sterile lancet. Wipe away the first sign of blood. Review the procedure and repeat the test with a new test device. If the problem persists,
【INTENDED USE】  Gently rub the hand from wrist to palm to finger to form a rounded drop of blood
The HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) is a chromatographic discontinue using the test kit immediately and contact your local distributor.
over the puncture site. 【QUALITY CONTROL PROCEDURES】
immunoassay for the rapid and qualitative detection of antibodies to Human  Add the whole blood sample into the test cassette using a capillary tube:
Immunodeficiency Virus (HIV) type 1, type 2 and subtype O in whole blood, serum or plasma Internal procedural controls are included in the test. A colored line appearing in the control
 Add blood to the end of the capillary tube until it is filled to about 50 µl. Avoid air region (C) is an internal procedural control. It confirms sufficient specimen volume and
to aid in the diagnosis of HIV infection. bubbles.
【SUMMARY】 correct procedural technique. Control standards are not supplied with this kit; however, it is
 Place the plunger on the top of the capillary tube and then squeeze it to dispense recommended that positive and negative controls be tested as a good laboratory practice
HIV (human immunodeficiency virus) is the causative agent of acquired all the blood into the specimen well of the test cassette.
immunodeficiency syndrome (AIDS). The virion is surrounded by a lipid to confirm the test procedure and to verify proper test performance.
 Collection of whole blood samples by venipuncture: 【LIMITATIONS】
membrane which originates from the cell membrane of the host cell. There are  Collection tubes containing anticoagulants such as K2EDTA, K3EDTA, potassium
several viral glycoproteins on the envelope. Each virus contains two copies of positive- citrate, lithium heparin, sodium oxalate, sodium heparin and sodium citrate are 1. The HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) is intended for in
stranded genomic RNAs. Human immunodeficiency virus type 1 (HIV-1) infection occurs suitable. vitro diagnostic use only. The test should only be used for the detection of HIV
throughout the body and can have dramatic physical effects, such as neurocognitive antibodies in whole blood, serum or plasma samples. Neither the quantitative value nor
impairment in the central nervous system.1 HIV-1 has been isolated in patients with AIDS  Preparation of serum/plasma samples: the rate of increase of HIV antibodies can be determined by this qualitative test.
and AIDS complex and in healthy people at high potential risk of AIDS.2 HIV-1 consists of  Separate serum or plasma from blood as soon as possible to avoid haemolysis. 2. The HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) will only indicate
subtype M and subtype O. Very different strains of HIV-1 were first identified in 1990 and Use only clear, non-haemolysed samples. the presence of HIV antibodies in the sample and should not be used as the sole
provisionally grouped as subtype O. This variant has similar glycoprotein markers to HIV-1,  Testing should be performed immediately after specimen collection. Do not leave the criterion for the diagnosis of HIV infection.
but only a slight difference in the protein marker. Infections caused by subtype O are rare samples at room temperature over a long period of time. Serum and plasma samples 3. For confirmation, further analysis of the samples should be performed according to the
compared to HIV-1 and HIV-2 infections. So far, they have been found in Africa can be stored at 2-8 °C for up to 3 days. For long-term storage, the samples guidelines of the local health authorities.
(Cameroon), France and Germany. HIV-2 has been isolated in West African AIDS patients should be kept below -20 °C. Whole blood collected by venipuncture should be 4. As with all diagnostic tests, all results must be interpreted together with other clinical
and in seropositive asymptomatic individuals.3 Both HIV-1, HIV-2 and subtype O trigger stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole information available to the physician.
immune responses.4 The detection of HIV antibodies in serum, plasma or whole blood blood samples. Whole blood collected by fingerstick should be tested immediately. 5. This test is intended for screening purposes only. The results are not intended to
is the most efficient and common method to determine whether a person has been  Bring specimens to room temperature prior to testing. Frozen specimens must be determine the serotype of HIV infection.
infected with HIV and to test blood and blood products for HIV. Despite the completely thawed and mixed well prior totesting. Specimens should not be frozen and 6. Because of possible cross-reactivity, the appearance of lines in both T1 and T2 does not
differences in their biological properties, serological activities and genome sequences of thawed repeatedly. necessarily indicate co-infection of HIV-1, HIV-2 and subtype O.
HIV-1, HIV-2 and subtype O show strong antigenic cross-reactivity.  If specimens are to be transported, they should be packed in compliance with local 7. If the test result is negative and clinical symptoms persist, additional testing using other
The HIV 1.2.O Rapid test Cassette (Whole Blood/Serum/Plasma) is a rapid test for the regulations. clinical methods is recommended. A negative result does not at any time preclude the
qualitative detection of antibodies against HIV type 1, type 2 and/or subtype O in whole possibility of HIV infection.
blood, serum or plasma samples. 【MATERIALS】
Materials Provided
【PRINCIPLE】
The HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative ● Test cassettes ● Pipettes
membrane-based immunoassay for the detection of antibodies against HIV-1, HIV-2 ● Buffer (0.02% NaN3 + 0.025% Kanamycinsulfate) ● Package insert 【EXPECTED VALUES】
and subtype O in whole blood, serum or plasma. The membrane is pre-coated with The HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) was compared with a
recombinant HIV antigens in the test line region T1 and T2. The T1 test line is pre- Materials required but not provided
commercial HIV ELISA test. The correlation between these two systems is 99.6%.
coated with HIV-1 and subtype O antigen, and the T2 test line is pre-coated with HIV-2
 Collection tubes 【PERFORMANCE CHARACTERISTICS】
antigen. During the test, the whole blood, serum or plasma sample reacts with HIV  Centrifuge (Serum/Plasma) Timer
 Lancets (only for fingerstick) Sensitivity and Specificity
antigen-coated particles in the test strip. The mixture then migrates upward on the
 Heparinised sample capillaries and dosing flasks (only for fingerstick) The HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) correctly identified
membrane chromatographically by capillary action and reacts with recombinant HIV
seroconversion panel samples and was compared to a leading commercial ELISA HIV test
antigen on the membrane in the test line region. If the sample contains antibodies against
【TEST PROCEDURE】 using clinical samples. The results show that the relative sensitivity of the HIV 1.2.O Rapid
HIV-1 and/or subtype O or HIV-2, a coloured line appears in the test line region. If the
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before Test Cassette (Whole Blood/Serum/Plasma) is > 99.9% and the relative specificity is
sample contains antibodies against HIV-1 and/or subtype O as well as HIV-2, two
use. 99.9%.
coloured lines appear in the test line region. Both options indicate a positive result.
Due to possible cross-reactivity of HIV-1, HIV-2 or subtype O seropositivity, two test lines 1. Bring the pouch to room temperature before opening it. Remove the test cassette from the
may occur in some cases. If the sample does not contain HIV-1, subtype O and/or sealed pouch and use it within one hour.
HIV-2 antibodies, no coloured line appears in the test region, which indicates a 2. Place the cassette on a clean, level surface. HIV 1.2.O-
negative result. To serve as a procedure control, a colored line will always appear Serum or plasma samples: Hold the pipette vertically and add 1 drop of serum Method
Rapid Test Cassette Correlation
in the control line region, indicating that proper volume of specimen has been added or plasma (approx. 25 µl) to the specimen well, then add 1 drop of buffer (approx. Results Positive Negative
and that the membrane had the intended capillary action. 40 µl) and start the timer. See illustration below.
Whole blood sample (venipuncture): Hold the pipette vertically and add 2 drops >99.9%
【REAGENTS】 HIV-1 360 0
of whole blood (approx. 50 µl) to the specimen well. Then add 1 drop of buffer (360/360)
The test contains recombinant HIV type 1, type 2 and subtype O coated particles and HIV >99.9%
type 1, type 2 and subtype O recombinant antigens applied to the membrane. (approx. 40 µl) and start the timer. See illustration below. HIV-2 100 0
3. Whole blood sample (fingerstick): Fill the capillary tube and add approximately 50 µl whole (100/100)
【PRECAUTIONS】 Positive
blood to the specimen well. Then add 1 drop of buffer (approx. 40 µl) and start the timer. HIV-1 Serotypes A-K
40 0 >99.9% (40/40)
 For professional in vitro diagnostic use only. Do not use after expiration date indicated See illustration below. (non-B-subtypes)
on the package. 4. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the >99.9%
Total 500 0
 Do not eat, drink or smoke in the area where the specimens and kits are handled. result after 20 minutes. (500/500)
 Do not use the test if its foil pouch is damaged. ELISA 99.9%
1 Drop of Serum or 2 Drops of Whole Blood donations 2 1498
 Handle all specimens as if they containinfectious agents. Observe established (1498/1500)
Plasma Blood (Venous)
precautions against microbiological hazards throughout the procedure and follow the >99.9%
Clinical negative 0 200
standard procedures for proper disposal of specimens. (200/200)
 Wear protective clothing such as laboratory coats, disposable gloves and eye 1 Drop of Buffer 1 Drop of Buffer Negative samples >99.9%
Negative 0 200
protectionwhen specimens are assayed. from pregnant women (200/200)
 The used testing materials should be discarded in accordancewith local, state and/or Positive Possibly interfering >99.9%
0 100
federal regulations. samples (100/100)
 Testing should be performed within one hour after opening the pouch. A relative 99.9%
Total 2 1998
humidity >60% and a temperature > 30 ℃ can particularly affect the results. (1998/2000)
50 µl of Whole Blood 99.9%
Negative Total Result 502 1998
(Fingerstick) (2498/2500)
Relative sensitivity =500/500= >99.9% (95%CI*: 99.4%~100.0%)
1 Drop of Buffer Relative specificity =1998/(1998+2)=99.9%(95%CI*: 99.6%~100%)
【STORAGE AND STABILITY】 Accuracy =(500+1998)/(500+2+1998)=99.9%(95%CI*: 99.7%~99.99%)
Store in the sealed pouch either at room temperature or refrigerated (2-30 °C). The test Invalid * Confidence intervals
is stable until the expiry date printed on the sealed pouch. The test must remain in Serum vs. Plasma
the sealed pouch until use. Once opened, the bottle of buffer solution can be stored for Sensitivity in seropositive paired serum and plasma samples
1.5 months at room temperature or refrigerated (2-30 °C). DO NOT FREEZE. Do not use 【INTERPRETATION OF RESULTS】
after the expiry date.
(See illustration above) A total of 60 serum and plasma seropositive pairs were tested with the HIV1.2.O Rapid
Test Cassette (Whole Blood/Serum/Plasma).
There was a good correlation of test results between serum and plasma with HIV
seropositive samples.

Number of samples Correlation (HIV 1.2.O Rapid

Sample type tested Test)
Paired Serum 60 >99.9%(60/60)
Paired Plasma 60 >99.9%(60/60)
Specificity in seronegative paired serum and plasma samples
A total of 130 seronegative paired serum and plasma from healthy volunteers were tested
with HIV 1.2.O Rapid Test Cassettes (Whole Blood/Serum/Plasma).
There was a good correlation of test results between serum and plasma with HIV
seronegative samples.
Number of samples Correlation (HIV 1.2.O Rapid
Sample type
tested Test)
Paired Serum 130 >99.9%(130/130)
Paired Plasma 130 >99.9%(130/130)
Accuracy
Intra Assay
Within-run precision was determined using 10 replicates of four samples: one negative,
one low, one medium and one high. The negative, low positive, medium positive and high
positive values were correctly detected > 99% of the time.

Inter Assay
Inter-run precision was determined by 10 replicates of four samples: one negative,
one HIV-1 low positive, one HIV-1 medium positive and one HIV-2 positive. Three
different batches of the HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma)
were tested with negative, HIV-1 low positive, intermediate HIV-1 samples and HIV-2
positive samples. The samples were correctly identified in more than 99% of the cases.
Cross-reactivity
The HIV1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) was tested with
positive HBc, HBs, HCV,HLTV I / II, HEV, rheumatoid factor (RF), CMV, EBV, malaria,
SYP and HSV samples. The results showed no cross-reactivity.
Interference Studies
The following potentially interfering substances were added to HIV-negative and positive
samples.
Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL
Acetylsalicylic acid: 20 mg/dL Gentisic acid 20 mg/dL
Ascorbic acid: 2g/dL Creatine: Albumin: 2 g/dL
200 mg/dL Bilirubin: 1g/dL Haemoglobin 1.1g/dL
Oxalic acid: 600mg/dL
None of the substances in the tested concentration caused interference with the
test.
【LITERATURE REFERENCES】
1. Bednar MM, et al. Compartmentalization, viral evolution, and viral latency of HIV in the
CNS. Curr HIV/AIDS Rep. 2015;12:262–271.
2. Chang, SY, Bowman, BH, Weiss, JB, Garcia, RE and White, TJ. The origin of HIV-1
isolate HTLV-IIIB. Nature (1993) 3;363:466-9
3. Arya, SK, Beaver, B, Jagodzinski, L, Ensoli, B, Kanki, PJ,Albert, J, Fenyo, EM, Biberfeld,
G, Zagury, JF and Laure, F. New human and simian HIV-related retroviruses possess
functional transactivator (tat) gene. Nature (1987) 328:548-550
4. Caetano JA Immunologic aspects of HIV infection. Acta Med Port (1991) 4 Suppl
1:52S-58S
5. Sholukh AM, et al. Defense-in-depth by mucosally administered anti-HIV dimeric IgA2
and systemic IgG1 mAbs: complete protection of rhesus monkeys from mucosal SHIV
challenge. Vaccine. 2015;33:2086–2095.
6. Bolton DL, et al. Human immunodeficiency virus type 1 monoclonal antibodies suppress
acute simian-human immunodeficiency virus viremia and limit seeding of cell-
associated viral reservoirs. J Virol. 2016;90:1321–1332
Index Of Symbols
Read instructions for use Tests per kit Authorized
Representative

In vitro diagnostic Do not reuse

medical device Use by

Store between 2-30 Batch Code

REF Catalog number

Do not use if the package

is damaged

Reference number: RP5346100

Effective date: 2020-09-15