LEAVE NO PATIENTS BEHIND

Determine™ HBsAg 2, with an analytical sensitivity of just 0.1 IU/mL, is a highly sensitive, easy-to-use rapid lateral flow test

Enables accurate identification of HBsAg-positive patients with results in just 15 minutes

Detects major HBsAg vaccine escape mutants

Ideal for use in a wide variety of healthcare settings

These deaths could be prevented with vaccination and protective measures.

In high HBV prevalence areas, the WHO recommends that all adults have routine access to and be offered HBsAg serological testing with linkage to prevention, care and treatment services. ²

Here are some concrete actions to take once these populations are screened:

icon1-1

Prevent HBV infection by identifying persons suitable for vaccination.

icon1-2

Prevent HBV transmission by identifying and educating all infected people.

icon1-3

Prevent health deterioration by providing recommendations on food and medicines for infected people to avoid.

icon1-4

Provide treatment to patients who need it.

FROM THE FEBRUARY 2017 GUIDELINES ON HEPATITIS B AND C TESTING, AS WRITTEN BY THE WORLD HEALTH ORGANIZATION (WHO)

WHO TO TEST FOR CHRONIC HBV INFECTION

TESTING APPROACH AND POPULATION

RECOMMENDATIONS*

General population testing

  1. In settings with a ≥2% or ≥5% 1 HBsAg seroprevalence in the general population, it is recommended that all adults have routine access to and be offered HBsAg serological testing with linkage to  prevention, care and treatment services.
    General population testing approaches should make use of existing community- or health facility-based testing opportunities or programmes such as at antenatal clinics, HIV or TB clinics.
    Conditional recommendation, low quality of evidence

Routine testing in pregnant women

  1. In settings with a ≥2% or ≥5% 1 HBsAg seroprevalence in the general population, it is recommended that HBsAg serological testing be routinely offered to all pregnant women in antenatal clinics 2 , with linkage to prevention, care and treatment services. Couples and partners in antenatal care settings should be offered HBV testing services.
    Strong recommendation, low quality of evidence

Focused testing in most affected populations

  1. In all settings (and regardless of whether delivered through facility- or community-based testing), it is recommended that HBsAg serological testing and linkage to care and treatment services be offered to the following individuals:
  • Adults and adolescents from populations most affected by HBV infection 3 (i.e. who are either part of a population with high HBV seroprevalence or who have a history of exposures and/or high-risk behaviours for HBV infection);
  • Adults, adolescents and children with a clinical suspicion of chronic viral hepatitis 4 (i.e. symptoms, signs, laboratory markers);
  • Sexual partners, children and other family members, and close household contacts of those with HBV infection 5 ;
  • Health-care workers: in all settings, it is recommended that HBsAg serological testing be offered and hepatitis B vaccination given to all health-care workers who have not been vaccinated previously (Adapted from existing guidance on Hepatitis B vaccination 6)

    Strong recommendation, low quality of evidence

Blood donors
Adapted from existing 2010 WHO guidance (Screening donated blood for transfusion
transmissible infections 7)

  1. In all settings, screening of blood donors should be mandatory with linkage to care, counselling and treatment for those who test positive.
Abbreviations: HBsAg: Hepatitis B surface antigen; PWID: People who inject drugs; MSM: Men who have sex with men *The GRADE system (Grading of Recommendations, Assessment, Development and Evaluation) was used to categorise the strength of recommendations as strong or conditional (based on consideration of the quality of evidence, balance of benefits and harms, acceptability, resource use and programmatic feasibility) and the quality of evidence as high, moderate, low or very low.
  1. A threshold of ≥2% or ≥5% seroprevalence was based on several published thresholds of intermediate or high seroprevalence. The threshold used will depend on other country considerations and epidemiological context.
  2. Many countries have chosen to adopt routine testing in all pregnant women, regardless of seroprevalence in the general population, and particularly where seroprevalence ≥2%. A full vaccination schedule including birth dose should be completed in all infants, in accordance with WHO position paper on Hepatitis B vaccines 2009.6
  3. Includes those who are either part of a population with higher seroprevalence (e.g. some mobile/migrant populations from high/intermediate endemic countries, and certain indigenous populations) or who have a history of exposures or high-risk behaviours for HBV infection (e.g. PWID, people in prisons and other closed settings, MSM and sex workers, HIV-infected persons, partners, family members and children of HBV infected persons).
  4. Features that may indicate underlying chronic HBV infection include clinical evidence of existing liver disease, such as cirrhosis or hepatocellular carcinoma (HCC), or where there is unexplained liver disease, including abnormal liver function tests or liver ultrasound.
  5. In all settings, it is recommended that HBsAg serological testing with hepatitis B vaccination of those who are HBsAg negative and not previously vaccinated be offered to all children with parents or siblings diagnosed with HBV infection or with clinical suspicion of hepatitis, through community- or facility-based testing.
  6. WHO position paper. Hepatitis B vaccines. Weekly epidemiological record. 2009;4 (84):405–20.
  7. Screening donated blood for transfusion transmissible infections. Geneva: World Health Organization; 2010
    Original Source:
    World Health Organization. Guidelines on Hepatitis B and C Testing February 2017. https://apps.who.int/iris/bitstream/handle/10665/254621/9789241549981-eng.
    pdf;jsessionid=36D2C766E7471A095B4CC9D485E5F601?sequence=1. Updated 2017. Accessed March 2020.
Please note that the Determine™ HBsAg 2 should not be used for screening of donated blood.

DETERMINE™ HBSAG 2 IS SIMPLE TO USE AND FACILITATES RAPID AND ACCURATE HEPATITIS B DIAGNOSIS IN MANY HEALTHCARE SETTINGS

SIMPLE PROCEDURE

ORDER INFORMATION

PRODUCT NAME PRODUCT CODE
Determine ™ HBsAg 2 (20 Tests, CE) 7D2946
Determine ™ HBsAg 2 (100 Tests, CE) 7D2947
Determine ™ HBsAg 2 (20 Tests, Non-CE) 7D2942
Determine ™ HBsAg 2 (100 Tests, Non-CE) 7D2943
Determine ™ HBsAg 2 SET (Non-CE)
Includes 100 Tests, Chase Buffer, 100 EDTA
Capillaries, 100 Sterilized Blood Lancets
7D2943SET
Chase Buffer (2.5 mL, 100 Tests) 7D2243
EDTA Capillaries (100 Tests, CE) 7D2227
EDTA Capillaries (100 Tests, Non-CE) 7D2222

PRODUCT SPECIFICATIONS

Method Lateral Flow
Sensitivity Analytical Sensitivity of 0.1 IU/mL
Specificity 99.6 %
Time to Result 15 Minutes
Storage Conditions 2°C–30°C
Test Conditions 18°C–40°C
Sample Volume 50 μL
Test Shelf Life 18 Months
Sample Types Serum/Plasma, Fingerstick Whole Blood and Venipuncture Whole Blood
  1. WHO Hepatitis B Key Facts July 18 2019. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b.
  2. WHO Guidelines on Hepatitis B and C Testing, Feb 2017. https://apps.who.int/iris/bitstream/handle/10665/254621/9789241549981-eng.pdf;jsessionid=36D2C766E7471A095B4CC9D485E5F601?sequence=1
Weight 0,2 kg

Reviews

There are no reviews yet.

Be the first to review “7D2942 – Det HBsAg S/P 20T”

Your email address will not be published. Required fields are marked

No Spesifikasi Product
1 Nama Produk DETERMINE™ HBsAg 2
2 Merk DETERMINE
3 Pabrik Abbott Diagnostic Medical Co., Ltd. Chiba, Japan
4 Negara Asal Jepang
5 Prinsip Pemeriksaan Immunochromatography Test
6 Kemasan 1 boks terdiri atas;
  • 100 Test Card
  • Test card terbungkus aluminium foil dalam kemasan asli pabrik dan tercantum masa kadaluwarsa
7 Kemampuan Deteksi
  • Mendeteksi Antigen Permukaan Virus Hepatitis B (HBsAg) dengan batas deteksi 0.1 IU/mL dalam sampel serum, plasma, dan whole blood manusia
  • Dapat mendeteksi 14 jenis mutan HBsAg
  • Hasil deteksi diperoleh dalam waktu 15 menit
8 Hasil Test Kualitatif
9 Spesimen Serum, Plasma, Whole blood
10 Volume Sampel 50 µl serum/plasma/whole blood (khusus whole blood ditambahkan 1 tetes Chase Buffer)
11 Sensitivitas & Spesifisitas Sensitivitas 98,6% dan Spesifisitas 100%
12 Suhu Penyimpanan 2-30ºC
13 Kadaluarsa 18 bulan dari tanggal produksi
14 No Katalog 7D2942
15 Registrasi Terdaftar di Kementrian Kesehatan RI
16 No Registrasi KEMENKES RI AKL 20305911113

Download Quick Reference Guide