IVD

2. Store Aehealth HCV rapid quantitative test cassette at 2～30℃, shelf lifeis up to 18 months.
3. Test cassette should be used within 1 hour after opening the pack.
MATERIALS SUPPLIED
HCV（Hepatitis C Virus Antibody）Rapid Test
（Immunofluorescence Assay） 25 Test Cassette
1 Test Cassette IC Card
For in vitro diagnostic use only. For professional use only. 1 Tube Whole Blood Buffer
PRODUCT NAME 1 Instructions for Use

MATERIALS REQUIRED BUT NOT PROVIDED

HCV（Hepatitis C Virus Antibody）Rapid Test（Immunofluorescence Assay）

SPECIFICATION Transfer Pipette Set (10 μL, 100 μL size)

Specimen Collection Containsers
1 test/kit, 10 tests/kit, 20 tests/kit, 25 tests/kit, 50 tests/kit, 100 tests/kit；
Sterile Lancets (for Fingerstick Whole Blood only)
INTENDED USE Alcohol Pads
Centrifuge (for Plasma/Serum only)
The HCV Rapid Test along with Aehealth FIA Meter is intended for vitro determination of Hepatitis C
Virus Antibody（ HCV） in human whole blood, serum or plasma. Timer

SUMMARY WARNINGS AND PRECAUTIONS

Hepatitis C virus (HCV) is an envelope, single stranded positive sense RNA (9.5 kb) virusbelonging to the family 1. This kit is for in vitro diagnostic use only.
of Flaviviridae. Six major genotypes and series of subtypes of HCVhave been identified. Isolated in 1989, HCV 2. Do not mix components from different kit lots.
is now recognized as the major cause fortransfusion associated non-A, non-B hepatitis. The disease is 3. Do not use test kit beyond the expiration date.
characterized with acute andchronic form. More than 50% of the infected individuals develop severe, life 4. Do not use test cassette if its lot # does not match with IC card # that is inserted onto the equipment.
threateningchronic hepatitis with liver cirrhosis and hepatocellular carcinomas. Since the introduction in 1990 5. The Aehealth HCV rapid test kit is only operational in the Aehealth FIA meter.
of anti-HCV screening of blood donations, the incidence of this infection in transfusion recipients has been 6. Do not use the test cassette if the pouch is punctured or not well sealed.
significantly reduced. Clinical studies show that significant amount of HCV infected individuals develop antibodies 7. The test cassette and meter should be used away from vibration and magnetic field. During normal usage, the Meter
to NS5 non-structural protein of the virus. For this, the tests include antigens from the NS5 region of the viral itself may cause vibration, which should be regarded as normal.
genome in addition to NS3 (c200), NS4 (c200) and the Core (c22). 8. Use separate clean pipette tips and detection buffer vials for different specimens.
9. Blood specimens, used test cassettes, pipette tips and detector buffer vials should be handled and disposed in
Cut-off：100
.Cut-off≥100, Positive， Hepatitis C Virus Antibody is detected in sample tested; accordance with standard procedures and relevant regulations of microbiological hazard materials.
10. The results should be interpreted by the physician along with clinical findings and other laboratory test results.
Cut-off＜100, Negative， Hepatitis C Virus Antibody is not detected or the concentration of Hepatitis C Virus
Antibody in sample been tested is lower than detection limit. SPECIMEN COLLECTION AND PREPARATION
Note: Individual reference range is suggested to be established for each laboratory.
The test can be performed with serum or plasma or whole blood.
PRINCIPLE OF THE PROCEDURE
For Whole Blood Collected by Venipuncture:
The Aehealth HCV Rapid Test is based on fluorescence immunoassay technology. The Aehealth
1. Using standard phlebotomy procedure, collect a venipuncture whole blood specimen using a blood collection tube
HCV Rapid test uses a sandwich immunodetection method, when sample is added to the sample well
of the test cassette, the fluorescence-labeled detector HCV antigen binds to HCV antibody in blood specimen. with suitable anticoagulant (EDTA recommended).
As the sample mixture migrates on the nitrocellulose matrix of test strip by capillary action, the complexes of 2. It is recommended that specimens should be tested immediately. Do not leave the specimens at room
detector antigen and HCV antibody are captured to HCV antigen that has been immobilized on test strip. Thus temperature for prolonged periods. If the specimens are not tested immediately, they may be stored at℃～8℃.
2
the more HCV antibody is in blood specimen, the more complexes are accumulated on test strip. Signal intensity 3. It’s not suitable to test the whole blood samples storing at 2℃～8℃for more than 2 days.
of fluorescence of detector antigen reflects amount of HCV captured and Aehealth FIA Meter shows HCV
For Serum and Plasma:
qualitative test results in blood specimen.
1. Separate the serum/plasma from blood as soon as possible to avoid hemolysis.
STORAGE AND STABILITY 2. Test should be performed immediately after the specimens have been collected. Do not leave the specimens
at room temperature for prolonged periods. Specimens may be stored at 2℃～8℃ for up to 3 days. For longterm
1. Store the detection buffer at 2～30℃. The buffer is stable up to 18 months.
storage, specimens should be kept below -20℃.
TEST PROCEDURE INDEX OF CE SYMBOLS

Refer to Aehealth FIA meter operation manual for the complete instructions on use of the test. The test should be
operated in room temperature. IVD In Virto Diagnostic
medical Device 2 Do Not Reuse

Step1: Preparation
Expiration Date Consult Instructions
For Use
Check/ swipe the IC card information to the equipment.
Step2: Loading
30℃
Store at 2-30℃ Date of Manufacturer
2℃

Serum / plasma: take 100μL of serum or plasma samples, load it onto the sample well of the test cassette;
Whole blood: take 120μL of whole blood sample, load it onto the sample well of the test cassette, immediately Manufacturer LOT Batch Code
add a drop of whole blood buffer to the sample well;
Warning, please refer to the
Step3: Testing ！ instruction in the annex
Keep Dry

Quick Test: After 15 minutes of sample adding reaction, insert the detection card into the carrier of the fluorescence Avoid overexposuer to the
immunoassay analyzer, click the “Test” button on the “Quick test” page, enter the information, and click “test” the CE Mark
sun
instrument will automatically detect and print the results; Don’t use the product when
the package is damaged Biological Risks
Timming Test: Insert the detection card into the carrier of the fluorescence immune analyzer immediately after
adding the sample, double click the "Timing test" button, enter the information and click “test”, after the automatic
EC REP Authorized Representative in the European Community
incubation countdown is over, click test, automatically detect, give the test results and print.

LIMITATIONS OF PROCEDURE Please read this user manual carefully before operating to ensure proper use.
Document No: 30900072 Version: 1.0
1. This test has been developed for testing human whole blood, serum and plasma specimen.
2. The results of Aehealth HCV Rapid Test should be evaluated with all clinical and laboratory data available. BASIC INFORMATION
If HCV test results do not agree with the clinical evaluation, additional tests should be performed.
3. The false positive results may come from cross-reactions with some similar antibodies in blood; and similar AEHEALTH LIMITED
epitopes from non-specific components in blood capturing fluorescent labeled antibodies. Address: Unit G25 Waterfront Studios, 1 Dock Road, London, United Kingdom, E161AH
4. EDTA other than anticoagulants (e.g. heparin or citrate) is suggested to use for plasma. Email: sales@aehealth.uk
5. Other factors may interfere with Aehealth HCV Rapid Test and may cause erroneous results. These EC REP MedNet EC-REP GmbH
include technical or procedural errors, as well as additional substances in blood specimens. Borkstrasse 10, 48163 Muenster, Germany
BIBLIOGRAPHY OF SUGGESTED READING

1.Choo Q-L,Weiner AJ, Overby LR, Kuo G, Houghton M. (1990) Hepatitis C Virus: themajor causative agent of viral
non-A, non-B hepatitis. Br Med Bull 46: 423-441.Choo Q-L,Weiner AJ, Overby LR, Kuo G, Houghton M. (1990)
Hepatitis C Virus: themajor causative agent of viral non-A, non-B hepatitis. Br Med Bull 46: 423-44.
2.Alter H J, Purcell RH,Shih JW, Melpolder JC, Houghton M, Choo Q-L, Kuo G.Detection of antibody to hepatitis C
virus in prospectively followed transfusion recipients with acute and chronic non-A, non-B hepatitis. N Engl J Med
1989;321:1494-500.
3.Choo Q-L, Weiner AJ, Overby LR, Kuo G, Houghton M. Hepatitis C virus: the majorcausative agent of viral non-A,
non-B hepatitis. Br Med Bull 1990; 46:423-41.