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Nairaland Forum / Nairaland / General / Health / COVID-19: Rapid Test Kits Banned In Nigeria - FG (21738 Views)
Guidelines For Validation Of Rapid Test Kits In Lagos / Jack Ma Helps Africa Fight Coronavirus. Donates Masks, Test Kits To African / We Are Not Stopping Chinese, Italians, Others From Visiting Nigeria — FG (2) (3) (4)
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Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Bobyro: 8:16am On May 31, 2020 |
letout:Exactly. The lack of lather made it fade out of sales. |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by blowjohn(m): 8:16am On May 31, 2020 |
kuntash: He used the topic to get attention or trend. That's the correlation. 1 Like |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Azmanaty: 8:18am On May 31, 2020 |
Dpharisee: This is his pics Ugly in character and face 1 Like 1 Share
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Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by ikorodureporta: 8:21am On May 31, 2020 |
Some people dey go church here-o! |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Havertz(m): 8:21am On May 31, 2020 |
Do and update ur with livescore jare |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by joyandfaith: 8:22am On May 31, 2020 |
lalasticlala: It is just professional advise from mlscn. it is only nafadac and fmoh that have powers to ban use of medical devices, drugs or food/herbal supplements https://www.nafdac.gov.ng/nafdac-grants-conditional-emergency-use-approval-of-medical-devices-covid-19-antibody-and-antigen-test-kits-ppes-etc-companies/ 1 Like |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by deltateam: 8:22am On May 31, 2020 |
lalasticlala: FG doesn't want private labs to hijack the process with attendant risks of contracting and spread of the disease. Let's do the mathematics Assuming 1 test kit costs #2000. A lab attendant buys 100 pieces uses it on 100 people @ #5000 per test. Profit calculation #3000 x 100 #300 000 |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Nobody: 8:23am On May 31, 2020 |
BOOOMNAIJA:LOL... I tell u |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by EmekaBlue(m): 8:35am On May 31, 2020 |
I've met this man to introduce our test kits. Really none has being approved so far |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by neonly: 8:38am On May 31, 2020 |
BOOOMNAIJA: Dis is omo detergent now |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by neonly: 8:42am On May 31, 2020 |
Dpharisee: You totally right |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Endoscopy: 8:48am On May 31, 2020 |
Dpharisee:pls sir what is ur biusness with this man he equally has right to his opinion as u do 1 Like 1 Share |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by wristbangle: 8:54am On May 31, 2020 |
BOOOMNAIJA: OMO rocks in the olden days with nice scents on clothes. The so called packaged ones of nowadays are no match for it in this aspect. Just that the foamy/lather property of it doesn't last hence the reason it was phased out from the market. 1 Like |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by FlordFlorez(m): 8:55am On May 31, 2020 |
They want the cases to be slow and steady. They dont want it in rush. They want to continue to cashout for very long time. Infact, covid19 will still be lucrative in 9ja while it must ended in other countries. |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Openbusiness: 9:09am On May 31, 2020 |
Dpharisee:Oil dey your head. Your brain na first class professor brain |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Meel: 9:19am On May 31, 2020 |
PRESS BRIEFING ON THE PROGRESS REPORT OF PRE-MARKET VALIDATION OF SARS-CoV-2 INFECTION (COVID-19) RAPID TEST KITS (RTKs) IN NIGERIA AND UNVEILING OF GUIDELINES FOR PRIVATE MEDICAL LABORATORIES SEEKING TO PROVIDE COVID-19 TESTING BY DR. TOSAN ERHABOR, REGISTRAR/CHIEF EXECUTIVE OFFICER, MEDICAL LABORATORY SCIENCE COUNCIL OF NIGERIA (MLSCN) ON FRIDAY, MAY 29, 2020. Preamble: The Medical Laboratory Science Council of Nigeria (MLSCN) in line with its statutory functions as stipulated in Act 11 of 2003 (CAP M25 LFN 2004), section 4 (b) and (e), which mandates MLSCN to regulate Medical Laboratory Science Practice in Nigeria as well as regulate the production, importation, sales and stocking of diagnostic reagents, equipment and chemicals respectively is providing information to the public on its regulatory functions. Progress report on Pre-market validation of SARS-CoV-2 Infection (COVID-19) Rapid Test Kits (RTKs). Unveiling of Guidelines for Private Medical Laboratories seeking to provide COVID-19 testing through completely private arrangement. Firstly, let me give update on the Pre-market validation of SARS-CoV-2 Infection (COVID-19) Rapid Test Kits (RTKs). Consequent upon the placement of an advert by MLSCN in four National Daily Newspapers on the 30th March, 2020 requesting for the submission of COVID-19 test kits by manufacturers or their sales representatives in the country for the purposes of validation. A total of eleven (11) In-Vitro Diagnostics; one (1) Polymerase Chain Reaction based kit, nine (9) Rapid Test Kits (2 Antigen based and 7 Antibody based kits) and 1Viral Transport Medium (VTM) were received for validation at the MLSCN Public Health In-Vitro Diagnostics Control Laboratory, Yaba, Lagos, Nigeria. However, out of the seven (7) Antibody based RTKs submitted for validation, only 4 of the RTKs met validation inclusion criteria. The validation of the PCR based kits and Antigen based Rapid Test Kits are ongoing. Goals and Objectives of the Validation of Rapid Test Kits: Goals: To validate the laboratory performance characteristics of Rapid Test Kits using Real-Time-Polymerase Chain Reaction method as reference standard for the detection of SARS-CoV-2 infection. Objectives: The report addressed the following specific objectives: To determine the sensitivity and specificity of the kits To determine the accuracy of the test kits To determine the inter-reader variability of the test results of the kits Results: Rapid Test Kits Characteristics Observed Performance (%) Generally Acceptable Minimum (95% CI) PRODUCT A Sensitivity 29.0 (22.6 - 37. ≥ 95% Specificity 94.0 (83.5 - 98.7) ≥ 95% Accuracy 45.8 (39.0 - 52.7) ≥ 95% PRODUCT B Sensitivity 51.4 (41.5 - 61.3) ≥ 95% Specificity 81.6 (68.0 -91.2) ≥ 95% Accuracy 61.0 (53.2 - 68.5) ≥ 95% PRODUCT C Sensitivity 22.1 (13.2 - 32.6) ≥ 95% Specificity 90.2 (78.6 - 96.7) ≥ 95% Accuracy 49.2 (40.3 - 57.4) ≥ 95% PRODUCT D Sensitivity 37.7 ( 26.9-49.4) ≥ 95% Specificity 85.1 (71.7 - 93. ≥ 95% Accuracy 55.6 ( 46.8 -64.2) ≥ 95% NOTE: PRODUCTS A, B, C, D ARE NOT THE BRANDED NAMES OF THE RTKs, THEY ARE USED FOR THE PURPOSE OF THIS BRIEFING. HOWEVER, THE FMoH HAVE THE COMPREHENSIVE REPORT. Observations: From the results above, the performance characteristics of four (4) COVID-19 Rapid Test Kits validated, fell below the generally acceptable minimum for In-vitro Diagnostics (IVD sensitivity and specificity of 95%). Therefore, none were approved for the purposes of diagnosis and surveillance in Nigeria. It became clear from the standardized validation done by MLSCN, that the manufacturers’ claims as contained in the product insert about Sensitivity, Specificity and Accuracy are not always correct. In this case, we observed a significant standard deviation, an indication that Rapid Test kits that are not validated poses higher risks of providing false positive and negative results. Comments: Though, all the Rapid Test kits validated, fulfilled the requirement to perform laboratory test without the need of equipment and were able to produce results in less than twenty (20) minutes. However, for a rapid test kit to be deployed for disease surveillance and diagnosis, it must be able to detect a disease-causing agent when it is present and to return a negative result if the causative agent is absent, i.e. it must possess good sensitivity so it can detect the presence of the disease and must equally have good specificity so that no interfering substances can lead to a false positive instead of true negative results in the absence of the etiological agent of the disease. Therefore, for a kit to be considered reliable for laboratory diagnosis and disease surveillance, the kit should have a high sensitivity and specificity. A kit performing very well in one of these characteristics without the other renders it unsuitable for diagnostic testing. It is also unsuitable if both characteristics are low. The four kits in this report have not met the expected performance characteristics of sensitivity and specificity to qualify their deployment for the purposes of testing in disease surveillance and routine diagnosis. MLSCN Validation Verdicts: The four (4) Rapid Test Kits validated so far, are NOT APPROVED for the purposes of diagnosis and surveillance of SARS-CoV-2 Infection in Nigeria. They are therefore NOT APPROVED for marketing in Nigeria. No SARS-CoV-2 Rapid Test kit is currently approved for use in Nigeria. We are using this opportunity to caution against the use of any non-validated Rapid Test Kits for COVID-19 testing in Nigeria as this will attract sanctions in accordance with the law. Secondly, let me also use this opportunity to unveil the Guidelines for Private Medical Laboratories seeking to provide COVID-19 testing through completely private arrangement. This guidance document has been developed by MLSCN in collaboration with NCDC, to guide engagement with the private sector medical laboratories to help accelerate the availability of COVID-19 diagnostic testing for the duration of the public health emergency in Nigeria. For these private medical laboratories, providing a public sector function, NCDC and its partners will continue to support the provision of reagents and consumables so that testing is conducted at no cost to the patient. Prospective Private Medical laboratories for COVID-19 testing must be granted approval by MLSCN in collaboration with NCDC in accordance with this Guidelines. However, those not granted this special approval and proceed to conduct COVID-19 testing, will be considered to have contravened the provisions of Section 4 (h) of MLSCN Act – “Medical Laboratories Regulations for Inspection, Approval, Monitoring and Accreditation” and will be sanctioned in line with the provisions of the said Regulation. These guidelines are available on MLSCN website www.mlscn.gov.ng. Please be properly guided. Conclusion The validation of other Rapid Test Kits for SARS-CoV-2 Infection is ongoing, as Nigerians will be informed when suitable test kits meet minimum validation requirements. MLSCN assures the Federal and State Ministries of Health and indeed the government of Nigeria of its commitment to ensuring quality healthcare delivery as enshrined in the statute books. Dr. Tosan Erhabor Registrar/CEO 1 Like |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Meel: 9:22am On May 31, 2020 |
joyandfaith: NAFDAC is empowered to regulate drugs, MLSCN has the power to ban any reagents they deem not worthy of use for diagnosis. it is in there act. MlSCN act To regulate the production, importation, sales and stocking of diagnostic laboratory reagents and chemicals. 1 Like |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Adex2442: 9:23am On May 31, 2020 |
BOOOMNAIJA: Is this not omo detergent? |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by donnie(m): 9:40am On May 31, 2020 |
Primusinterpares: You shall all be vaccinated |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by donnie(m): 9:43am On May 31, 2020 |
DominusPrime: Which kind yeye checking. Na him dem never check the herbal solutions wey dey our country since? Abeg they should chop WHO money quietly and leave us alone. |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Offpoint: 9:51am On May 31, 2020 |
BOOOMNAIJA:Lol, the baddest detergent then... Good old days |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by adekS1(m): 9:51am On May 31, 2020 |
Heavensent01:I just think l shd let u know that in any situation in Nigeria either good or bad someone must gain from it either legitimately or illegitimately. Its not only in Nigeria ppl are cashing out thru this,its the same in US too.in any misfortune someone must gain frm it,it now depend on wat services u r rendering thats highly essential. Its normal some ppl are being made millionaires thru this Covid-19 wrk e.g hypo company av make millions thru this Covid-19 cos their sales went up during this period,a lot of ppl are using their product especially frontline health workers involved in Covid-19 response who use Hypo a lot as part of their chemicals for disinfection. I pray God wl gv us the grace to patiently ask questions on wat we dont know so as nt to just be misinforming ppl.tnx 1 Like |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Originalsly: 10:03am On May 31, 2020 |
Good move. Why allow inaccurate kits to be used?.... those against the ban... would you like to go do an HIV test and told you're positive?... but you are not? |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by davidbanner(m): 10:28am On May 31, 2020 |
TheRealProphet: wetin man go do 1 Like |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Nobody: 10:29am On May 31, 2020 |
davidbanner: |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Nwaonyishi69: 10:33am On May 31, 2020 |
The importers did not pay their tites to the regulating persons. |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by MayenKudi: 10:43am On May 31, 2020 |
Morray:true that, if they could validate it everyone could easily get tested, meanwhile have you considered getting the Camon 15 premier? |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Danielkupiejo: 10:50am On May 31, 2020 |
Which one be indomie generation stop that nonsense, I dont know y u find fun in everything, tins dey advance u dey shout indomie generation tell me wot generation are u ? BOOOMNAIJA: |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by joyandfaith: 10:53am On May 31, 2020 |
Meel: they do not have the power. try to read nadfac act very well. even pcn does not regulate importation and safety concerns on drugs. pcn can only advice nafdac. |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by Rodwave: 11:03am On May 31, 2020 |
BOOOMNAIJA:LOL back in the days. |
Re: COVID-19: Rapid Test Kits Banned In Nigeria - FG by seproperties(m): 11:18am On May 31, 2020 |
The Government should Provide enough then . |
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