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[Biological Tests
Sl no |
Group of products, materials or items tested |
Specific tests or types of tests performed |
Specification, standard (method) or technique used |
Range of testing/ Limit of detection |
MU
(± ) |
1. |
Enzymes & Hormones
1. Streptokinase bulk
2. Streptokinase inj. |
Clot Lysis |
Clot formation and lysis within 30 min with human plasma and no lysis with bovine plasma.
Ref: IP2007 |
4000 IU/ml – 10000 IU/ml |
Not applicable |
2. |
Blood Products
1.Human Albumin –
5%, 20%, 25% |
Stability |
The content of the final container remain unchanged, as determined by visual inspection, after heating at 570C for 50 hrs when compared to its control consisting of a sample from the same lot which has not undergone this heating.
Ref: IP2007 |
---- |
Not applicable |
3. |
Blood Products
1.Human Albumin –
5%, 20%, 25% |
Immunodiffusion Double, Ouchterlony |
Precipitation tests with suitable range of species –specific antisera which give positive results for the presence of proteins of human origin and negative results with antisera specific to plasma proteins of other test.
Immunodiffusion Double, Ouchterlony
Ref: IP2007 |
0.3%-0.078% protein |
Not applicable |
4. |
Enzymes & Hormones
1. Streptokinase bulk
2. Streptokinase inj.
3. Heparin inj. |
Sterility |
Direct inoculation method, Membrane and Closed Methods
Ref: IP2007 |
---- |
Not applicable |
Recombinant Product
1. rh-Insulin inj.
2. rh-Insulin Glargine inj. |
-DO- |
Closed Methods
Ref: USP |
---- |
5. |
Enzymes & Hormones
1. Streptokinase bulk
2. Streptokinase inj. |
Abnormal Toxicity |
Animal test on mice and guinea pigs
Should comply with the monograph
Ref: IP2007 |
---- |
Not applicable |
6. |
Blood Products
Human Albumin –
5%, 20%, 25% |
Pyrogen Test |
Animal Tests on Rabbits
Ref: IP2007 |
---- |
Sl no |
Group of products, materials or items tested |
Specific tests or types of tests performed |
Specification, standard (method) or technique used |
Range of testing/ Limit of detection |
MU
(± ) |
7. |
Enzymes & Hormones
1. Streptokinase bulk
2. Streptokinase inj.
3. Heparin inj. |
Bacterial Endotoxin – Lal Test – Gel clot |
Gel Clot Method
Should not more than 23.33EU/ml of Streptokinase 10000IU/ml
and should not be more than 0.03EU/ml for Heparin
Ref: IP2007 |
0.5 EU/ml to 0.125 EU/ml |
Not applicable |
Recombinant Product
1. rh-Insulin inj.
2. rh-Insulin Glargine inj. |
-DO- |
Less than 80 IU / 100 IU
Ref: EP / BP/ USP |
0.03 EU/ml –
0.06 EU/ml
Lysate sensitivity as per maximum valid dilution. |
Not applicable |
8. |
Blood Products
Albumin-5%, 20%, 25% |
HAEM |
Not more than 0.15 at 403 nm
In-house control/ Human albumin-Sigma
Ref: IP2007 |
0.0017 – 2.3 OD at 403 nm ( 1.75 mg to 0.85 µg of haem ) |
In process |
9. |
Immuno diagnostic kits
1. Diagnostic kits for HIV 1 & 2 Antibody & Antigen |
Rapid test |
- Immuno-chromatography Method
- Immuno-filtration method
- Immuno-dot assay
Ref. : WHO Reports
- HIV Assays: Operational characteristic ; Report 11 (1999) and Report 14 (2004).
- HBsAg Assays: Operational characteristics; Report 2 (2004).
- HCV Assays: Operational characteristics; January 2001.
Drugs Controller General of India’s Letter No.26-1/Misc/2003-DC, dated12.06.03, Directorate General of Health Services (Drug Control Section) |
Sensitivity
HIV > 99.5%
HCV > 99%
HBsAg > 99%
Specificity
HIV > 98%
HCV > 98%
HBsAg > 98% |
In process |
2. Diagnostic Kits for HCV Antibody |
3. Diagnostic Kits for HBs Antigen |
10. |
-DO- |
ELISA |
Ref. : as above |
-DO- |
In process |
11. |
-DO- |
Confirmatory assays
|
- Immuno – Blot --- HIV & HCV
- Neutralization assay --- HBsAg
Ref. : as above |
-DO- |
In process |
12. |
Diagnostic Kits for Syphilis |
Rapid test |
|
---- |
In process |
Sl no |
Group of products, materials or items tested |
Specific tests or types of tests performed |
Specification, standard (method) or technique used |
Range of testing/ Limit of detection |
MU
(± ) |
13. |
Blood grouping reagents |
Potency (Titre) |
Tube Method |
1. Anti-A |
-DO- |
Cells |
Titre |
A1 |
1:256 |
1:2 to 1:4096 or above |
In process |
A2 |
1:128 |
A2B |
1:64 |
2. Anti-B |
-DO- |
B |
1:256 |
A1B |
1:128 |
3. Anti-A,B |
-DO- |
A1 |
1:256 |
B |
1:256 |
A2 |
1:128 |
4.Anti-D(IgM) |
-DO- |
R1r or R1R2 |
IS |
370C |
1:64 - 1:128 |
1:128 - 1:256 |
5. Anti-D(IgM+IgG) |
-DO- |
R1r or R1R2 |
1:32 - 1:64 |
1:128 - 1:256 |
6. Anti-D(IgG) |
-DO- |
R1r or R0r |
> in-house / Working standard |
7. Anti-A1(Lectin) |
-DO- |
A1(2) |
1:8 (1+) |
1:1 to 1:128 or above |
A1B (2) |
1:4 (+) |
8. Anti-H(Lectin) |
-DO- |
O (2) |
1:8 (1+) |
A2(2) |
1:4 (+) |
A1(2) |
1:1 – 1:2 (1+) |
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14. |
1. Anti-A |
Potency (Avidity)
|
Slide Method |
------ |
In process |
Cells |
Avidity (Seconds) |
A1 |
3 - 4 |
A2 |
5 - 6 |
A2B |
5 - 6 |
2. Anti-B |
-DO- |
B |
3 - 4 |
A1B |
5 - 6 |
3. Anti-A,B |
-DO- |
A1 |
3 - 4 |
B |
3 - 4 |
A2 |
5 - 6 |
4.Anti-D(IgM) |
-DO- |
R1r or R1R2 |
5 - 10 |
5. Anti-D(IgM+IgG) |
-DO- |
R1r or R1R2 |
10 - 20 |
Sl no |
Group of products, materials or items tested |
Specific tests or types of tests performed |
Specification, standard (method) or technique used |
Range of testing/ Limit of detection |
MU
(± ) |
15 |
1. Anti-A |
Potency (Intensity)
|
Slide Method |
Not Applicable |
Not Applicable |
Cells |
Intensity |
A1 |
3+ |
A2 |
2+ to 3+ |
A2B |
4+ |
2. Anti-B |
-DO- |
B |
4+ |
A1B |
2+ to 3+ |
3. Anti-A,B |
-DO- |
A1 |
4+ |
B |
4+ |
A2 |
3+ |
4.Anti-D(IgM) |
-DO- |
R1r or R1R2 |
3+ |
5. Anti-D(IgM+IgG) |
-DO- |
R1r or R1R2 |
3+ |
6. Anti-A1(Lectin) |
-DO- |
A1(2) |
2+ to 3+ |
7. Anti-H(Lectin) |
-DO- |
O (2) |
3+ to 4+ |
A2(2) |
2+ |
A1(2) |
< 2+ |
Sl no |
Group of products, materials or items tested |
Specific tests or types of tests performed |
Specification, standard (method) or technique used |
Range of testing/ Limit of detection |
MU
(± ) |
16. |
1. Anti-A |
Specificity |
Tube Method |
Not Applicable |
Not Applicable |
Cells |
Specificity |
A1 |
Positive |
A2 |
Positive |
A2B |
Positive |
B |
Negative |
O |
Negative |
2. Anti-B |
-DO- |
B |
Positive |
A1B |
Positive |
A1 |
Negative |
O |
Negative |
3. Anti-A,B |
-DO- |
A1 |
Positive |
B |
Positive |
A2 |
Positive |
Ax |
Positive |
O |
Negative |
4.Anti-D(IgM) |
-DO- |
R1r or R1R2 |
Positive |
IAT - Negative |
Negative |
5. Anti-D(IgM+IgG) |
-DO- |
R1r or R1R2 |
Positive |
IAT - Negative |
Negative |
6. Anti-D( IgG) |
-DO- |
R1r or R0r (Sensitized) |
Positive |
R1r or R0r (Unsensitized) |
Negative |
7. Anti-A1 (Lectin) |
-DO- |
A1(2) |
Positive |
A1B (2) |
Positive |
A2(2) |
Negative |
A2B(2) |
Negative |
B(2) |
Negative |
O(2) |
Negative |
8. Anti-H (Lectin) |
-DO- |
O (2) |
Positive |
A2(2) |
Positive |
A1(2) |
Weak Positive |
Oh (2) |
Negative |
Sl no |
Group of products, materials or items tested |
Specific tests or types of tests performed |
Specification, standard (method) or technique used |
Range of testing/ Limit of detection |
MU
(± ) |
17. |
1. Anti-A |
Reactivity
Rouleaux/
Haemolysis/Prozone |
Microscopic and Tube Method |
Not Applicable |
Not Applicable |
Cells |
Reactivity(Rouleaux/Haemolysis/Prozone) |
A1 |
Absent |
A2 |
Absent |
A2B |
Absent |
B |
Absent |
O |
Absent |
2. Anti-B |
-DO- |
B |
Absent |
A1B |
Absent |
A1 |
Absent |
O |
Absent |
3. Anti-A,B |
-DO- |
A1 |
Absent |
B |
Absent |
A2 |
Absent |
Ax |
Absent |
O |
Absent |
4.Anti-D(IgM) |
-DO- |
R1r or R1R2 |
Absent |
IAT - Negative |
Absent |
5. Anti-D(IgM+IgG) |
-DO- |
R1r or R1R2 |
Absent |
IAT - Negative |
Absent |
6. Anti-D( IgG) |
-DO- |
R1r or R0r (Sensitized) |
Absent |
R1r or R0r (Unsensitized) |
Absent |
7. Anti-A1 (Lectin) |
-DO- |
A1(2) |
Absent |
A1B (2) |
Absent |
A2(2) |
Absent |
A2B(2) |
Absent |
B(2) |
Absent |
O(2) |
Absent |
8. Anti-H (Lectin) |
-DO- |
O (2) |
Absent |
A2(2) |
Absent |
A1(2) |
Absent |
Oh (2) |
Absent |
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