Test rapid pentru detectia HBsAg din ser sau plasma Cod: THB03

Transcription

1 Test rapid pentru detectia HBsAg din ser sau plasma Cod: THB03 INTRODUCERE: Hepatita este un termen general care indica inflamatia ficatului, care poate fi cauzata de o varietate de virusuri. Un diagnostic corect se stabileste prin analiza serului pacientului, pentru detectia antigenelor virale sau a anticorpilor specifici. Hepatita B este o infectie comuna a ficatului, care afecteaza milioane de oameni in toata lumea. Consecintele patologice severe ale infectiei cu HBV includ insuficienta hepatica cronica, ciroza si carcinomul hepatocelular. In plus, purtatorii de HBV pot transmite boala timp de multi ani. Infectia apare foarte des in copilarie si este asimptomatica, putand duce la cronicizare. ¾ din populatia lumii traieste in zone cu nivel mare al infectiei. In fiecare an sunt peste 4 milioane de cazuri clinice de hepatita B acuta si aproximativ 25% dintre purtatori - 1 milion de oameni, mor in fiecare an de hepatita cronica, ciroza sau cancer hepatic. Determinarea HBsAg identifica indivizii infectati cu HBV. Metodele imunoenzimatice () sunt considerate a fi mai sensibile si de aceea sunt larg folosite. Testele rapide se folosesc pentru detectia rapida calitativa a HBsAg din ser sau plasma. Heptatita B Panel pentru interpretarea rezultatelor Teste Rezultate Interpretare HBsAg, Anti-HBc, Anti-HBs Negativ, negativ, negativ Sensibil HBsAg, Anti-HBc, Anti-HBs Negativ, pozitiv, pozitiv Imunitate dupa infectare naturala HbsAg, Anti-HBc, Anti-HBs Negativ, negativ, pozitiv Imunitate dupa vaccinare** HbsAg, Anti-HBc, Anti-HBc IgM, Anti-HBs Pozitiv, pozitiv, pozitiv, negativ Infectie acuta HbsAg, Anti-HBc, Anti-Hbc IgM, Anti HBs Pozitiv, pozitiv, negativ, negativ Infectie cronica HbsAg, Anti-HBc, Anti-HBs Negativ, pozitiv, negativ Patru posibile interpretari* *Patru interpretari: 1. Poate fi in recuperare dupa o infectie acuta cu HBV. 2.Poate fi slab imun, test cu o sensibilitate mult prea scazuta pentru a putea detecta nivelul scazut de anti-hbs din proba. 3. Poate fi sensibil cu un rezultat anti-hbc fals pozitiv. 4. In proba poate fi prezent AgHbs la un nivel nedetectabil iar persoana poate sa aiba o infectie cronica. ** Raspunsul anticorpilor (Anti-HBs) poate fi masurat cantitativ cat si calitativ. Un raspuns protector al anticorpilor este raportat cantitativ ca sau mai multe miliunitati internationale (>miu/ml) sau calitativ ca pozitiv. Pentru un rezultat relevant testarea trebuie sa fie finalizata la 1-2 luni dupa a treia doza de vaccin. DEFINITII: *Antigen Hepatita B de Suprafata (AgHBs): marker serologic pe suprafata HBV ce poate fi detectat in ser in cantitate mare, in cazul hepatitelor acute sau cronice. Prezenta AgHBs indica faptul ca pacientul este infectat. Corpul produce in mod normal anticorpi anti-hbs ca raspuns al sistemului imunitar la infectie. *Anticorp Hepatita B de Suprafata (anti-hbs): prezenta anticorpilor anti-hbs este interpretata ca indicator de recuperare sau imunizare la infectia cu HBV. Deasemenea acesti anticorpi apar si la persoanele care au fost vaccinate impotriva hepatitei B. *Anticorpi totali Hepatita B (CORE) (Anti -HBc): Apare la declansarea simptomelor de hepatita B acuta si persista pe viata. Prezenta anticorpilor anti-hbc indica o infectie anterioara sau in curs de desfasurarea cu virus hepatic B (HBV). *Anticorpi IgM anti-hepatita B (CORE) (IgM anti-hbc): Acesti anticorpi apar in cazul infectiei acute sau recente cu HBV si sunt prezenti timp de 6 luni. SCOP: Testul rapid HBsAg este un test imunocromatografic pentru detectia calitativa a HBsAg din ser sau plasma. REACTIVI: Anticorpi anti-hbsag monoclonali, anticorpi anti-igg de soarece policlonali de capra, anticorpi anti-hbsag monoclonali conjugati cu particule de aur coloidal. PRINCIPIU: Testul HBsAg este un test imunocromatografic in faza solida pentru determinarea calitativa a HBsAg in probe de ser uman sau plasma. Acesta este un test two-site imunometric in care este folosita o combinatie de anticorpi monoclonali si policlonali pentru a detecta selectiv HbsAg din ser sau plasma, avand un grad ridicat de sensibilitate. Anticorpi anti-hbsag monoclonali au fost imobilizati in zona T iar anticorpi anti-igg de soarece policlonali de capra au fost imobilizati in zona C pe membrana de nitroceluloza. Anticorpi anti-hbsag monoclonali au fost conjugati cu particule de aur coloidal si lasati sa se usuce pe membrana pentru conjugat. Daca exista HBsAg in proba, acesta se leaga de anticorpii anti-hbsag monoclonali conjugati cu particule de aur coloidal. Complexul astfel format se deplaseaza mai departe prin membrana catre regiunea test T. Antigenele de suprafata ale hepatitei B se leaga de anticorpii anti-hbsag monoclonali imobilizati iar ca rezultat, HBsAg ce s-a legat deja de anticorpii anti-hbsag monoclonali mobili (conjugati cu particule de aur coloidal) raman imobilizati in zona T unde formeaza o banda colorata datorita acumularii particulelor de aur coloidal din aceasta zona, indicand un rezultat pozitiv. Daca in proba nu este prezent HBsAg, proba se deplaseaza spre zona T impreuna cu anticorpii anti-hbsag monoclonali conjugati cu particule de aur coloidal nelegati. Anticorpii anti-hbsag monoclonali imobilizati nu se pot lega de anticorpii mobili anti-hbsag conjugati cu particule de aur coloidal, deci nu se formeaza nicio banda vizibila in zona T, indicand un rezultat negativ. Indiferent de continutul de HBsAg, anticorpii anti-hbsag monoclonali mobili conjugati cu particule de aur coloidal se leaga de anticorpii anti-igg de soarece policlonali de capra in timpul in care proba traverseaza prin zona de control C. Prin urmare, acumularea de particule de aur coloidal produce o banda vizibila in zona de control C (o linie de control colorata), indicand faptul ca testul e valid. Banda de control trebuie sa fie prezenta in zona C in orice caz. Daca nu este prezenta nicio banda colorata in zona de control C inseamna ca testul este invalid. 1

2 PRECAUTII SI LIMITARI ALE TESTULUI: 1. Este destinat doar testarii in vitro, pentru uz profesional. 2. A nu se utiliza dupa data expirarii. Casetele sunt de unica folosinta, a nu se reutiliza. 3. Casetele trebuie pastrate in ambalajul original, sigilat. Nu folositi testul daca ambalajul este desigilat sau degradat. 4. Utilizati manusi de unica folosinta in timpul efectuarii testului. 5. Folositi o pipeta pentru fiecare proba in parte. 6. Manevrati probele ca fiind potential infectate. Urmariti standardele de biosecuritate pentru manevrarea si aruncarea materialelor potential infectante. 7. Testul indica numai prezenta sau absenta Anti-HBs in proba, iar rezultatele trebuie corelate si cu alte date clinice in stabilirea diagnosticului. De retinut faptul ca stabilirea unui diagnostic nu trebuie sa se bazeze pe un singur rezultat. Stabilirea diagnosticului se realizeaza de catre un expert dupa evaluarea tuturor datelor clinice. PASTRARE: Kit-ul trebuie pastrat ferit de lumina solara directa, umezeala, temperaturi ridicate sau surse de radiatii. Pastrati kit-ul la C pe toata perioada valabilitatii, asa cum este indicat pe punguta. Acesta este stabil pe toata perioada de valabilitate daca este pastrat in conditii optime. Dispozitivul de testare trebuie folosit in maxim o ora de la desigilare. Nu congelati kit-ul sau componentele acestuia. Componentele trusei: Casete test, picuratoare, instructiuni de utilizare. Materiale necesare dar nefurnizate: Eprubete, centrifuga si cronometru. Materiale recomandate dar nefurnizate: Micropipete, controale negativ si pozitiv. RECOLTAREA SI PREGATIREA PROBELOR: Testul se poate efectua folosind probe de ser sau plasma. Pentru a evita hemoloiza, serul sau plasma trebuie separate cat mai repede posibil. Pentru probele de ser: sangele se recolteaza intr-o eprubeta fara anticoagulant, se lasa pobele timp de 30 de minute pentru a se coagula, se centrifugheaza (4000 rpm, minute) si se foloseste serul obtinut. Pentru probele de plasma: pentru evitarea coagularii sangelui, proba se recolteaza in eprubete ce contin anticoagulant (EDTA, heparina, citrat). Se centrifugheaza (4000 rpm, minute) si se foloseste plasma obtinuta. Nu utilizati probe tulburi sau hemolizate. Daca probele de ser sau plasma nu pot fi testate in ziua recoltarii, pastrati-le la frigider sau la congelator. Evitati ciclurile repetate de inghet-dezghet. Inainte de testare aduceti probele la temperatura camerei. Probele congelate trebuie dezghetate si bine omogenizate inainte de testare. Probele ce prezinta turbiditate trebuie centrifugate. Folosirea probelor congelate/decongelate trebuie evitata pe cat posibil datorita riscului de blocare a membranei din cauza debriurilor rezultate. MOD DE LUCRU: 1. Inainte de inceperea testarii, aduceti toate componentele kit-ului si probele la temperatura camerei ( C). Deschideti punguta si scoateti dispozitivul. 2. Aspirati ser/plasma in pipeta si pipetati 3 picaturi (0μl) in godeul casetei destinat probei. Evitati formarea bulelor de aer. 3. In functie de concentratia de HBsAg din proba, testul poate prezenta un timp de reactie si de 5 minute. Rezultatul trebuie citit dupa 15 minute precum este indicat mai jos. A nu se citi rezultatul dupa mai bine de 20 de minute dupa testare, rezultatele aparute dupa 20 de minute sunt considerate invalide. INTERPRETAREA REZULTATELOR Negativ: Apare numai o banda colorata in regiunea C, antigenul HBs nu exista in proba. Pozitiv: Doua benzi colorate sunt vizibile. Pe langa banda de control din regiunea C, mai apare o banda distincta in regiunea T, indicand existenta antigenului HBs in proba respectiva. Concentratiile scazute de HBsAg pot duce la formarea unei benzi slabe in regiunea T. Oricat de slaba ar fi intensitatea benzii aparuta in regiunea T, testul trebuie interpretat ca fiind pozitiv. Invalid: Testul este invalid daca nu apare banda de control. In acest caz, este necesara repetarea testului cu un nou dispozitiv. CONTROLUL CALITATII: Controlul intern al dispozitivului este inclus pe membrana de nitroceluloza, in regiunea C. Dupa efectuarea testului, utilizatorul va observa o linie colorata in zona C a testului ceea ce indica un rezultat negativ si doua linii colorate in zonele T si C ale testului ceea ce indica un rezultat pozitiv. Aparitia liniei C este considerata procedura de control a testului indicand faptul ca s-a adaugat un volum suficient de proba precum si faptul ca rezultatul este valid. Control suplimentar: Se recomanda utilizarea controlului, pozitiv si negativ altele decat controlul inclus in caseta, pentru a confirma buna performanta a trusei. 2

3 CARACTERISTICI DE PERFORMANTA: Acest test HBsAg poate detecta toate subtipurile antigenelor de suprafata ale virusului hepatitei B. Numar subiecti Stare proba Stare proba Anti-HBs Test efectuat pentru Rezultat comparare rezultat 420 Infectat natural Pozitiv 0% 54 Donator Negativ 0% 250 Clinica Negativ 0% 276 Femei insarcinate Negativ 0% 150 Factor reumatoid (FR) Negativ 0% Bilirubina Negativ 0% Hemoglobina Negativ 0% Trigliceride Negativ 0% Anti-HCV Negativ Standard WHO 0% Valoare Cut-off este de 0.26 IU/ml (0.5 ng/ml) Sensibilitate: 0% Specificitate: 0% +predictiv V: 0% - predictiv V: 0% Paneluri de seroconversie: Utilizandu-se testul rapid HBsAg Turklab au fost realizate 30 panele de seroconversie, ca referinta a fost folosita o determinare. Toate cele 30 seroconversii au fost bine identificate. Aceasta evaluare indica faptul ca trusa de teste rapide rapid HbsAg Turklab poseda o sensibilitate echivalenta cu cea a unei metode marca CE. Reactivitate incrucisata: Reactivitatea incrucisata a fost testata cu probele de mai jos, nu a fost observata reactivitate incrucisata cu testul rapid HBsAg: - Anticorpi anti HCV cu probe din ser/plasma, - Ser/ plasma din probe recoltate de la femei insarcinate. Interferente: Urmatoarele substante potential interferente au fost testate cu testul rapid HBsAg: hemoglobina, bilirubina, trigliceridele, factor reumatoid (FR). Nu au fost observate interferente. Probele hemolizate nu ar trebui folosite deoarece pot genera rezultate invalide sau false. Trusa este destinata utilizarii cu probe din ser/plasma. Utilizarea de sange integral poate genera rezultate invalide sau false. BIBLIOGRAFIE: 1. Hollinger FB, Liang TJ. Hepatitis B Virus. In: Knipe DM et al., eds. Fields Virology, 4th ed. Philadelphia, Lippincott Williams & Wilkins, 2001: patitis/ whocdscsrlyo20022/en/index1.html 2. Ganem D, Schneider RJ. Hepadnaviridae: The Viruses and Their Replication. In: Knipe DM et al., eds. Fields Virology, 4th ed. Philadelphia, Lippincott Williams & Wilkins, 2001: World Health Organization. Introduction of hepatitis B vaccine into childhood immunization services.geneva, WHO, 2001 (unp ublished document WHO/V&B/01.31 available on request from Department of Vaccines and Biologicals, World Health Organization, 1211 Geneva 27, Switzerland) DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control and PreventionDivision of Viral Hepatitis 5. Current information on Rapid Diagnostic Tests - Rapid Tests for Hepatitis Diagnostic Overview / PATH-a catalyst for global health, 2006, TR RO: en , Rev: (A) ms V. EN:

4 i n v itr o d i agnosti c test Product Code: THB03 Hepatitis B Virus Surface Antigen Cassette Test. BACKGROUND INFORMATION INTENDED USE HBsAg Test is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human serum / plasma. REAGENTS Anti-HBs monoclonal antibody, goat anti-mouse IgG polyclonal antibody and anti-hbs monoclonal antibody conjugated with colloidal gold particles. METHOD PRECAUTIONS AND LIMITATIONS STORAGE SAMPLE COLLECTION AND PREPARATION INSTRUCTION FOR USE SENSITIVE ONE STEP TEST Detection in Serum / Plasma Only for professional in vitro diagnostic use Hepatitis is a general term meaning inflammation of the liver and can be caused by a variety of different viruses such as hepatitis A, B, C, D and E. Since the development of jaundice is a characteristic feature of liver disease, a correct diagnosis can only be made by testing patients' sera for the presence of specific anti-viral antigens or antibodies. Of the many viral causes of human hepatitis few are of greater global importance than hepatitis B virus (HBV).Hepatitis B is a serious and common infectious disease of the liver, affecting millions of people throughout the world. The severe pathological consequences of persistent HBV infections include the development of chronic hepatic insufficiency, cirrhosis, and hepatocellular carcinoma (HCC). In addition, HBV carriers can transmit the disease for many years. Infection occurs very often in early childhood when it is asymptomatic and often leads to the chronic carrier state. More than 2000 million people alive today have been infected with HBV at some time in their lives. Of these, about 350 million remain infected chronically and become carriers of the virus. Three quarters of the world's population live in areas where there are high levels of infection. Every year there are over 4 million acute clinical cases of HBV, and about 25% of carriers, 1 million people a year, die from chronic active hepatitis, cirrhosis or primary liver cancer. Detection of Hepatitis B surface antigen (HBsAg) identifies individuals infected with the hepatitis B virus. Quantitative enzyme immunoassay () methods are considered to be the most sensitive tests and are widely used at well-equipped reference centers or central blood banks. Rapid tests are intended for qualitative detection of HBsAg in human serum, plasma or whole blood wherever methods are impractical or cannot be sustained. Tests HBsAg, anti-hbc, IgM anti-hbc, anti-hbs HBsAg, anti-hbc, IgM anti-hbc, anti-hbs Interpretation of the Hepatitis B Panel Results, negative, negative, positive, positive, negative, positive Positive, positive, positive, negative Positive, positive, negative, negative, positive, negative HBsAg Interpretation Susceptible Immune due to natural infection Immune due to hepatitis B vaccination ** Acutely infected Chronically infected Four interpretations possible * * Four Interpretations: 1. Might be recovering from acute HBV infection. 2. Might be distantly immune and test not sensitive enough to detect very low level of anti-hbs in serum. 3. Might be susceptible with a false positive anti-hbc. 4. Might be undetectable level of HBsAg present in the serum and the person is actually chronically infected. ** Antibody response (anti-hbs) can be measured quantitatively or qualitatively. A protective antibody response is reported quantitatively as or more milliinternational units ( miu/ml) or qualitatively as positive. Post-vaccination testing should be completed 1-2 months after the third vaccine dose for results to be meaningful. DEFINITIONS * Hepatitis B Surface Antigen (HBsAg): A serologic marker on the surface of HBV. It can be detected in high levels in serum during acute or chronic hepatitis. The presence of HBsAg indicates that the person is infectious. The body normally produces antibodies to HBsAg as part of the normal immune response to infection. * Hepatitis B Surface Antibody (anti-hbs): The presence of anti-hbs is generally interpreted as indicating recovery and immunity from HBV infection. Anti-HBs also develops in a person who has been successfully vaccinated against hepatitis B. * Total Hepatitis B Core Antibody (anti-hbc): Appears at the onset of symptoms in acute hepatitis B and persists for life. The presence of anti-hbc indicates previous or ongoing infection with hepatitis B virus (HBV) in an undefined time frame. * IgM Antibody to Hepatits B Core Antigen (IgM anti-hbc): This antibody appears during acute or recent HBV infection and is present for about 6 months. HBsAg Test uses solid-phase immunochromatographic technology for the qualitative detection of HBsAg in human serum /plasma. The test is a two-site immunometric assay in which a combination of monoclonal and polyclonal antibodies is used to selectively detect HBsAg in samples with a high degree of sensitivity. Anti-HBs monoclonal antibody was immobilized on the test area T and goat anti-mouse IgG antibody was immobilized on the control area C of the nitrocellulose membrane. Anti-HBs monoclonal antibody conjugated with colloidal gold particles was dried on a conjugate pad. Sample is introduced from sampling pad. If there is HBsAg in the sample, HBsAg binds to the mobile anti-hbs monoclonal antibodies conjugated with colloidal gold particles. Together they move to the test area T. Hepatitis B surface antigens bind to the immobilized anti-hbs monoclonal antibodies and as a result of this, HBsAg that have already bound to mobile anti-hbs monoclonal antibodies (conjugated with colloidal gold particles) become immobilized in the test area T thus creating a visible colored signal due to the accumulation of colloidal gold particles in the test area T (a colored test line), indicating positive test result. If there is no HBsAg in the sample then sample moves to the test area T together with unbound (free) anti-hbs monoclonal antibodies conjugated with colloidal gold particles. Immobilized anti-hbs monoclonal antibodies can not bind to mobilized anti-hbs monoclonal antibodies conjugated with colloidal gold particles, therefore no visible colored signal in the test area T (no colored test line) can be obtained, indicating negative test result. Regardless of HBsAg content of the liquid sample, mobile anti-hbs monoclonal antibodies conjugated with colloidal gold particles, bind to immobilized goat anti-mouse IgG antibodies while liquid sample is passing through the control area C. Therefore accumulation of colloidal gold particles produces a visible colored signal in the control area C (a colored control line), indicating a valid test result. Colored line should be visible in the control area C in every case; if no visible colored line in control area C, test result should be indicated as invalid. 1. For professional and in vitro diagnostic use only. 2. Do not use test kit beyond expiry date. The test device is single use. Do not reuse. 3. The test device should remain in its original sealed pouch until usage. Do not use the test if the seal is broken or the pouch is damaged. 4. Wear disposable gloves while performing the test. 5. Use a new dropper for each sample. 6. All patient samples should be handled as taking capable of transmitting disease into consideration. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of samples. 7. This test will indicate only the presence or absence of HBsAg in the sample, and should not be used as the only basis for the diagnosis of hepatitis viral infection. As with all diagnostic tests, it should be kept in mind that an identification diagnosis can't be based on a single test result.diagnosis can only be reached by an expert after the evaluation of all clinical and laboratory findings. Test device should be kept away from direct sunlight, moisture, heat and radiation sources. Store at 4-30 C (39-86 F). Do not freeze. The test in the original packaging retains stable until expiry date at storage conditions. The test device should be used in maximum one hour after the foil is opened. Kit components : Test cassettes, droppers and instructions for use. Additional materials required but not provided : Sample collection tube, centrifuge and timer. Additional materials recommended but not provided : Micropipettes to deliver mentioned amount of sample in the test procedure, negative and positive control materials. The test can be performed using serum or plasma. To avoid hemolysis, serum or plasma should be separated from blood as soon as possible. For Serum Samples: Collect blood into a collection tube without anticoagulant, leave to settle for 30 minutes for blood coagulation and then centrifuge the blood. At the end of centrifuge period remaining supernatant is used as serum.(centrifugation time & speed: minutes, 4000 rpm) For Plasma Samples: Collect blood into a collection tube with anticoagulants (EDTA, heparin, citrate should be used) to avoid coagulation of blood sample and then centrifuge the blood. At the end of centrifuge period supernatant is used as plasma.(centrifugation time & speed: minutes, 4000 rpm) Do not use turbid, hemolyzed samples. If the sample cannot be tested on the day of collection, store the serum, plasma samples in a refrigerator or freezer. Do not freeze and thaw the serum, plasma samples repeatedly. Bring the samples to room temperature before testing. Frozen samples must be completely thawed and mixed well prior to testing. Turbid test samples should be centrifuged. Using of frozen and thawed samples should be avoided whenever possible, due to the blocking of the membrane by the debris.

5 TEST PROCEDURE 1. Bring the tests and serum / plasma samples to room temperature, Take the test out of its pouch. 2. Draw serum / plasma into dropper and put 3 drops (0 µl) into the sample well of the cassette. Avoid the formation of any air bubbles. 3. Depending on the HBsAg concentration in the sample, the test can react even in 5 minutes. Results should be read at 15 minutes as shown below. Do not interpret results beyond 20 minutes, results forming after 20 minutes should be regarded as invalid. INTERPRETATION OF RESULTS : Only one colored line is visible in C area, indicating that hepatitis B surface antigen does not exist. Positive: Two colored lines are visible in C and T areas, indicating that hepatitis B surface antigen exists. Low concentration of hepatitis B surface antigen may cause a faint line in T area. Even such a faint line in T area should be regarded as positive. Invalid: No colored line is visible or only one colored line is visible in T area; test should be repeated using a new test device. NEGATIVE POSITIVE INVALID INVALID QUALITY CONTROL Tests have built in procedural quality control features. When the test is complete, the user will see a colored line in the C area of the test on negative samples and a colored line in the T and C area on positive samples. The appearance of the control C line is considered as an internal procedural control. This line indicates that sufficient volume of sample was added as well as valid test result. It is recommended that a negative control and a positive control be used to verify proper test performance as an external control. Users should follow appropriate federal, state and local guidelines concerning the external quality controls. PERFORMANCE EVALUATION HBsAg Test can detect all subtypes of hepatitis B virus surface antigens. Study Number Cut-off: 0,26 IU/mL (0,5 ng/ml french ng ) Sample Status Sample HBsAg Status Comparative Assay Used Result Naturally acute or chronic infected Blood donors Clinical Pregnant women Rheumatoid Factor (RF) Bilirubin Hemoglobin Triglycerides Anti-HCV Positive WHO Standard Sensitivity : Specificity : + Predictive V : - Predictive V : Seroconversion panels: 30 seroconversion panels for Türklab HBsAg Test were conducted where was the reference assay. All 30 seroconversions were properly detected by the Türklab HBsAg Test which reacted positive with the appearance of a line at C area for the control and with another line at T area for the test sample. The predicate assay also detected the seroconversion of all 30 panels. This evaluation indicates that Türklab HBsAg Test has demonstrated an equivalent performance in the diagnostic sensitivity compared to the CE-marked assay. Cross Reactivity: Cross reactivity has been tested with below samples, no cross reactivity was found with the HBsAg Test. - Anti-HCV positive serum / plasma samples, - Serum / plasma samples from pregnant women. Interferences: Following potentially interfering substances were tested with HBsAg Test: Hemoglobin, Bilirubin, Triglycerides, Rheumatoid Factor (RF). No interference was observed. Hemolytic samples should not be used since they can cause to invalid or false results. The test is designed for serum / plasma samples. Using whole blood samples may cause invalid or false results. REFERENCES 1. Hollinger FB, Liang TJ. Hepatitis B Virus. In: Knipe DM et al., eds. Fields Virology, 4th ed. Philadelphia, Lippincott Williams & Wilkins, 2001: whocdscsrlyo20022/en/index1.html 2. Ganem D, Schneider RJ. Hepadnaviridae: The Viruses and Their Replication. In: Knipe DM et al., eds. Fields Virology, 4th ed. Philadelphia, Lippincott Williams & Wilkins, 2001: World Health Organization. Introduction of hepatitis B vaccine into childhood immunization services.geneva, WHO, 2001 (unpublished document WHO/V&B/01.31 available on request from Department of Vaccines and Biologicals, World Health Organization, 1211 Geneva 27, Switzerland) DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control and PreventionDivision of Viral Hepatitis 5. Current information on Rapid Diagnostic Tests - Rapid Tests for Hepatitis Diagnostic Overview / PATH-a catalyst for global health, 2006, TÜRKLAB TIBBİ MALZEMELER SAN. ve TİC. A.Ş. ITOB 031 Sokak No: 15 Tekeli Menderes Izmir / TURKEY T: ï F: ï ï info@turklab.com.tr Manufacturer Consult instruction for use Attention, see instruction for use In vitro diagnostic medical device n For single use only Number of test Catalog number Storage temperature Lot number Expiry date Instruction For Use Preparation Date: Rev.6 C08.THBG.01