Alere Hepatitis Products

Presenter: Indra Bagus Nugroho

DMaleo Hotel, Mamuju

29th April 2017

CONFIDENTIAL. INTERNAL USE ONLY.

RDTs (Immunochromatography Assay)

Add
Sample Test Control
Conjugate
Line line

Colloidal gold
conjugated

CONFIDENTIAL. INTERNAL USE ONLY.

 Keuntungan RDTs
Hasil dapat segera diketahui pada hari yang sama (20 menit)
Tidak membutuhkan alat, tetapi tenaga harus dilatih
Akurasi cukup bagus: sensitivitas >99%; spesifisitas >99%
Sample dapat menggunakan serum/plasma/whole blood
Volume spesimen sedikit
Tanpa harus ada listrik dan air yang stabil (minim limbah)
Mudah mengintepretasikan hasil
Mudah cara penyimpanannya (bisa pada suhu kamar), tidak perlu
khusus di lemari pendingin dengan suhu (2-8)0 C
Shelf life atau masa kadaluarsa 24 bulan (2 tahun) sejak masa produksi
Untuk pemeriksaan skala terbatas (1-40 test per hari)
Harga relatif murah
Rapid test sangat cocok untuk digunakan di daerah perifer yg
tidak/kurang lengkap fasilitasnya serta jumlah pasien/hari tidak terlalu
banyak (< 40 sample/minggu)

CONFIDENTIAL. INTERNAL USE ONLY.

Rapid Test = Screening
(Kualitatif)

CONFIDENTIAL. INTERNAL USE ONLY. 3

 Meaning of Marker and Feature

SD BIOLINE HBs Ag and SD BIOLINE HBs Ag WB

Earliest Indicator Detection Limit Sensitivity : 100%

of Acute HBV : 1ng/ml Specificity : 100%
infection Evaluated by WHO

CONFIDENTIAL. INTERNAL USE ONLY. 4

 SD BIOLINE HBsAg

One step immunochromatographic assay

Hepatitis B surface antigens detection

Detection Limit : 1 ng/ml

Sensitivity : 100%

Specificity : 100%

Specimen : serum / plasma / whole blood

Evaluated by WHO, BBLK

CONFIDENTIAL. INTERNAL USE ONLY.

SD BIOLINE HBsAg

CONFIDENTIAL. INTERNAL USE ONLY.

SD BIOLINE HBsAg Procedures

CONFIDENTIAL. INTERNAL USE ONLY. 7

 SD Hepatitis B Evaluation

SD BIOLINE HBs Ag Evaluation Data WHO

CONFIDENTIAL. INTERNAL USE ONLY.

 SD Hepatitis B Evaluation

SD BIOLINE HBs Ag Evaluation Data - CDC

CONFIDENTIAL. INTERNAL USE ONLY.

 SD Hepatitis B Evaluation

SD BIOLINE HBs Ag Evaluation Data - BBLK

CONFIDENTIAL. INTERNAL USE ONLY.

 SD Hepatitis B Troubleshooting
How should HBsAg be stored?
2-30 C

What type of patient sample do I have to use?

Human serum, plasma and whole blood
For whole blood and plasma specimens, EDTA collection tube must be used.
For whole blood collection by Fingerstick, EDTA capillary tube must be used.
For testing whole blood specimens, Chase Buffer is required.

How critical is the timing?

The timing is critical and you cannot obtain the correct results if you do not
follow the instruction exactly.

CONFIDENTIAL. INTERNAL USE ONLY.

 SD Hepatitis B Troubleshooting
How long are the results stable?
The result can be read at 20 minutes

The Test Line was fainter than the Control Line, what does this mean?
The test result is positive even if the Test Line appears lighter or darker than
the Control Line.

No line has appeared in the Control Window, what does this mean?
The test is invalid. You will have to use a new device and run the test again.

What is the shelf-life of SD BIOLINE HBsAg?

Up to a maximum of 24 months from the date of manufacture

CONFIDENTIAL. INTERNAL USE ONLY.

 SD Hepatitis B Troubleshooting
If I add whole blood and forget to add chase buffer will the test still run?
You cannot obtain the correct result. It should be tested again.

Would a negative result conclude that a patient does not have Hepatitis
B?
No diagnostics test provides absolute assurance that a sample does not
contain low levels of HBsAg such as those present at a very early stage of
infection. Therefore, a negative result at any time does not preclude the
possibility of exposure to or infection with HBsAg.

What are the storage conditions for Serum and Plasma samples?
Serum and plasma samples should be stored at 2-8C if the test is to be run
within 7 days of collection. If testing is delayed more than 7 days, the sample
should be frozen (-20C or colder).
CONFIDENTIAL. INTERNAL USE ONLY.
 SD Hepatitis B Troubleshooting
What are the storage conditions for whole blood samples?
Whole blood collected by venipuncture should be stored at 2-8C if the test is
to be run within 7 days of collection. Do not freeze whole blood samples.
Whole blood collected by fingerstick should be tested immediately.

What volume does the EDTA capillary tube deliver?

SD: 100l

Can cloudy serum or plasma samples be used with the Determine tests?
No. Specimens showing particulate matter or turbidity should be centrifuged
before testing in order to avoid providing erroneous results.

CONFIDENTIAL. INTERNAL USE ONLY.

 SD Hepatitis B Troubleshooting
By detecting early markers of Hepatitis B infection, the Alere rapid HBsAg helps
to diagnose acute infection and confirm chronic infection - allowing healthcare
professionals to initiate prompt and appropriate follow-up action for infected
patients.

Easy to use and highly flexible, the Alere rapid HBsAg requires minimal
training, no equipment and can be relied upon for fast, accurate diagnosis in
the most basic of healthcare settings.

Refrigeration storage is not required with the Alere rapid and it has built in
flexibility to be used with whole blood or serum/plasma, collected either by a
fingerstick or venous puncture.

CONFIDENTIAL. INTERNAL USE ONLY.

CONFIDENTIAL. INTERNAL USE ONLY.