Note: To be followed only for Convalescent Plasma collection for treating COVID-19 patients as a national emergency protocol. Reversal of donor selection criteria as per Drugs & Cosmetic act to be considered after the pandemic ends. For references Drugs & Cosmetic act to be referred before deciding on taking up plasma collection. Few criteria are modified in the best interests & benefits of donors & patient safety in view of national emergency.

Method of collection: Apheresis Primary criteria:

  1. Donor should have reports of confirmed positivity by RT PCR for COVID -19 infection.

  2. Donor should have recovered completely and have completed14 days period after recovery.

  3. Donor should have report of Confirmed RT PCR Negativity, twice or at two occasions 24 hrs. apart.

  4. Donor should have report of high titer (>1: 1000) antibody of IgM & IgG antibody against Novel Corona virus infection by ELISA.

  5. Donor should have neutralization antibody pertaining to COVID-19 (Titer>40) by ELISA

  6. ABO matching with the patient blood group

  7. Non-Reactive for HIV, HBsAg, HCV, Malaria & Syphilis

  8. Donor Should provide Consent for collection of his plasma, as per the protocol.

Secondary Selection Criteria as Per Drug & Cosmetic Act & Rules (Amended Latest: 2020)

S. No

Query point

Criteria

(Individual case by case decision)

Additional opinion needed

in case of

1

Age

18-50 years

If age > 50 years up to 60

years

2

Gender

Preferably Males & Nulliparous

females

Multiparous females

3

Well being

Donor shall be in good health and mentally alert to understand & provide consent for the plasma

collection

Donor should have recovered from Recent infection from COVID -19

is accepted as per current national

emergency

Differently abled persons

4

Volume to be

collected

400 ml

In case of more volume to

be collected

5

Weight of the donor

Minimum 50 kg

6

Accessibility to Vein

Prominent cubital veins preferably on two arms or at

least one arm

Central line placement and collection

7

Frequency of donation

At least 48 hours interval after platelet/

plasma – apheresis shall be kept

(not more than 2 times

a week, limited to 24 in one year)

Additional donations

If donor has donated any other blood or blood components previously

8

BP

Systolic / diastolic: Not less than 100 / 60 and up to 150 /

90

Above 150 /90

9

Pulse

60-100, regular

Any variation to be

reviewed

10

Temperature

Afebrile: 98.4 F

11

Respiration

Donor shall be free from

respiratory difficulty / disease

12

Hemoglobin / CBC

>= 12.5 g/dl; with Normal

Values

Any abnormal values

13

Female donors

Should not be pregnant, breast feeding, recently aborted (in

last 6 months)

14

Surgeries

No major surgery in last 6

months

Minor surgeries

15

Risk of TTIs

No risk procedures in last 6

months

Like tattoos, blood

transfusion

The following diseases & disorders are permanently deferred from blood donation in view of their health conditions. Few mild cases are accepted as per the table. –

System

Permanent deferred Conditions

Accepted conditions

Respiratory

Asthmatics with or without

treatment / steroids

Chronic sinusitis

Mild URTI till symptoms subside

& Off treatment one week after last dose of medicine

Cardiac

Open heart surgery

Active cardiac related symptoms like chest pain, shortness of breath, pedal oedema etc.

Coronary Heart Disease

Angina Pectoris

Rheumatoid Heart Disease with

residual damage

CNS

Convulsions / Epilepsy

Migraine if not severe

Schizophrenia

Anxiety & mood disorders if vitals

stable

Endocrine Disorders

Diabetics on Insulin or MODS

Diabetics on oral medications

provided no Immunosuppression is suspected

Recently diagnosed Diabetics or

dose modified recently

Diabetics on oral medications

without any vascular lesions

Diabetics with suspected

Immunosuppression treatments

Thyroid disorders like

Hypothyroid on

Euthyroid

thyroxine

if

status & no symptoms

Thyrotoxicosis / Graves Disease

Malignant thyroid disorders

Other Endocrine disorders

Gastro Intestinal system

Viral Hepatitis infection

Known Hep A & E infection after one

year from recovery

Chronic

Failure

Liver

Disease

/ Liver

Jaundice due to H/o

assymptomatic gall stones

Chronic ulcer / malignancy

Assymptomatic APD / GERD / mild

/ uncomplicated hernia

Immuno Suppression

PLHA or K/c/o HIV or AIDS

Persons on immunosuppression treatments for autoimmune

disorders

Infectious Conditions

STDs like syphilis / Gonorrhoea

Measels / Mumps/ Chicken pox –

after 2 weeks

Leishmaniasis

Malaria after 3 months

Leprosy

Typhoid after 6 months

Dengue / Chikungunya after 6

months

Zika / West Nile infection after 4

months

Tuberculosis after 2 year following

confirmation of recovery

Renal System

Chronic Renal infection / CKD /

CRF

Acute UTI after

complete recovery

2

weeks

after

Acute pyelonephritis after 6

months after complete recovery

Others

Chronic AutoImmune Disorders

Polycythemia vera

Bleeding disorders: (un)explained

Malignancy

Severe allergic disorders

Haemoglobinopathies

Medications

Insulin

Anti-arrhythmic, Anticonvulsions, Anticoagulant, Antithyroid drugs, Cytotoxic drugs,

Cardiac Failure Drugs (Digitalis)

Oral contraceptive Analgesics, Vitamins

Mild sedative and tranquillizers Allopurinol

Cholesterol lowering medication

Other medications have individual deferral periods ranging from few days to 6 months and the individual decisions will be taken – To be referred to Drugs & Cosmetic Act & rules 2020.